MEDICAL DEVICES REGULATIONS

SUBSIDIARY LEGISLATION 427.44

MEDICAL DEVICES REGULATIONS

21st March, 2010

LEGAL NOTICE 210 of 2008, as amended by Legal Notice 320 of 2020.

(1) The title of these regulations is the Medical Devices

Regulations.

(2)

These regulations transpose the following Directives

(a) Council Directive 93/42/EEC * of 14th June 1993 on

the approximation of the laws of the Member States

relating to medical devices;

(b) Council Directive 2003/12/EC † of 3rd February 2003

on the reclassification of breast implants in the

framework of Directive 93/42/EEC concerning

medical devices;

(c) Council Directive 2003/32/EC ‡ of 23rd April 2003

introducing detailed specifications as regards the

requirements laid down in Council Directive 93/42/

EEC with respect to medical devices manufactured

utilising tissues of animal origin;

(d) Council Directive 2005/50/EC § of 11th August 2005

on the reclassification of hip, knee and shoulder joint

replacements in the framework of Council Directive

93/42/EEC concerning medical devices;

(e) Directive 2007/47/EC ** of the European Parliament

and of the Council of 5th September 2007 amending

Council Directive 90/385/EEC on the approximation

of the laws of the Member States relating to active

implantable medical devices, Council Directive 93/42/

EEC concerning medical devices and Directive 98/8/

EC concerning the placing of biocidal products on the

market.

(3)

The following transitional measures will remain applicable

(a) The placing on the market and putting into service of

*OJ No. L.169, 12-07-1993, p.1. Directive as last amended by Regulation (EC) No.

1882/2003 of the European Parliament and of the Council of 29 September 2003

adapting to Council Decision 1999/468/EC the provisions relating to committees

which assist the Commission in the exercise of its implementing powers laid down in

instruments subject to the procedure referred to in Article 251 of the EC Treaty (OJ

No. L.284, 31-10-2003, p.1).

†OJ No. L.28, 04-02-2003, p.43.

‡OJ No. L.105, 26-04-2003, p.18. These regulations lay down detailed specifications

in relation to risks of transmitting transmissible spongiform encephalopathies (TSE)

under normal conditions of use to patients or others, via medical devices manufactured

utilising animal tissue which is rendered non-viable or non-viable products derived

from animal tissue.

§OJ No.L.210, 12-08-2005, p.41.

**OJ No. L.247, 21-09-2007, p.21.

MEDICAL DEVICES

medical devices which have been subjected to EEC

pattern approval in accordance with Directive 76/764/

EEC shall be accepted until 30th June 2004.

(b) The placing on the market of devices which conform

to the rules in force in Malta on 31st December 1994

shall be accepted for a period of five years following

the adoption of Directive 93/42/EEC. The putting into

service of such devices shall be accepted until 30th

June 2001 at the latest.

(c) Holders of EC design-examination certificates or EC

type-examination certificates issued before 1st April

2004 for medical devices referred to in the definition

for "medical device manufactured utilising tissues of

animal origin" in regulation 3 shall apply for a

complementary EC design-examination certificate or

EC

type-examination

certificate attesting

to

compliance with the specifications laid down in

Schedule XIII.

(d) The placing on the market and the putting into service

of medical devices referred to in definition for

"medical device manufactured utilising tissues of

animal origin" in regulation 3 which are covered by an

EC design-examination certificate or an EC type-

examination certificate issued before 1st April 2004

shall be accepted until 20th September 2004.

(e) Breast implants placed on the market before 1st

September 2003 pursuant to regulation 6(3)(a) or

6(3)(b)(iii) shall be subject to a conformity

reassessment procedure as Class III medical devices

before 1st March 2004.

(f)

By way of derogation from regulation 6(10), the

decisions on breast implants taken by the notified

bodies before 1st September 2003 under regulation

6(3)(a) may not be extended.

(g) Hip, knee and shoulder replacements that have been

subject to a conformity assessment procedure pursuant

to regulation 6(3)(a) before 1st September 2007 shall

be subject to a complementary conformity assessment

under section 4 of Schedule II leading to an EC

design-examination certificate before 1st September

2009. This provision does not preclude a manufacturer

from submitting an application for conformity

assessment based on regulation 6(1)(b).

(h) Hip, knee and shoulder replacements that have been

subject to a conformity assessment procedure pursuant

to regulation 6(3)(b)(iii) before 1st September 2007

may be subject to a conformity assessment as Class III

medical devices pursuant to regulation 6(1)(b)(i) or

(ii) before 1st September 2010. This provision does

not preclude a manufacturer from submitting an

application for conformity assessment based on

regulation 6(1)(a).

(i)

The placing on the market and the putting into service

of hip, knee and shoulder replacements covered by a

Decision in accordance with regulation 6(3)(a) issued

before 1st September 2007 shall be accepted until 1st

September 2009.

(j)

The placing on the market of hip, knee and shoulder

replacements which are covered by a Decision in

accordance with regulation 6(3)(b)(iii) issued before

1st September 2007, shall be accepted until 1st

September 2010 and permitted to be put into service

beyond this date.

(1) These regulations shall apply to medical devices and

their accessories as follows

(a) for the purposes of these regulations, accessories shall

be treated as medical devices in their own right; and

(b) both medical devices and accessories shall hereinafter

be termed "devices".

(2)

(a) Devices shall be divided into Classes I, IIa, IIb and III.

Classification shall be carried out in accordance with

Schedule IX. In the event of a dispute between the

manufacturer and the notified body concerned,

resulting from the application of the classification

rules, the matter shall be referred for decision to the

Medicines Authority if the notified body is designated

in Malta.

(b) By way of derogation from the rules set out in

Schedule IX, breast implants shall be reclassified as

medical devices falling within Class III. By way of

derogation from the rules set out in Schedule IX, hip,

knee and shoulder replacements shall be reclassified as

medical devices falling within Class III.

(c) When it is considered that -

(i)

application of the classification rules set out in

Schedule IX requires a decision with regard to

the classification of a given device or category

of devices; or

(ii) a given device or family of devices should be

classified, by way of derogation from the

provisions of Schedule IX, in another class; or

(iii) the conformity of a device or family of devices

should, by way of derogation from article 6, be

established by applying solely one of the given

procedures chosen from among those referred to

in article 6 of these regulations; or

(iv) a decision is required as to whether a particular

product or product group falls within one of the

definitions for "accessory", "custom-made

device",

"device

intended

for

clinical

investigations", "in vitro diagnostic medical

device" or "medical device" in article 3,

the Medicines Authority shall submit a duly

substantiated request to the Commission and ask it to

take the necessary measures.

(3)

(a) For the purposes of these regulations, the Medicines

Authority will act as Malta’s national competent

authority in terms of the Committee referred to in

Article 6 of Directive 93/42/EEC and with respect to

the exchange of information, necessary to enable these

r e g u l a t i o n s t o b e a p p l i e d u n i f o r m l y, w i t h o t h e r

Member States and the Commission.

(b) For the purposes of these regulations, the Medicines

Authority will act as Malta’s national competent

authority with respect to exchange of experience

organised by the Commission in order to coordinate

the uniform application of these regulations.

For the purposes of these regulations, the following

definitions shall apply

"accessory" means an article which whilst not being a device is

intended specifically by its manufacturer to be used together with a

device to enable it to be used in accordance with the use of the

device intended by the manufacturer of the device;

"animal tissues" covered by these regulations are those tissues

originating from bovine, ovine and caprine animal species, as well

as deer, elk, mink and cats;

"authorised representative" means any natural or legal person

established in the Community or in Malta who, explicitly

designated by the manufacturer, acts and may be addressed by

authorities and bodies in the Community or in Malta instead of the

manufacturer with regard to the latter’s obligations under these

regulations;

"cell" means the smallest organised unit of any living form

which is capable of independent existence and of replacement of its

own substance in a suitable environment;

"CE marking" means marking as set out in Schedule XII;

"clinical data" means the safety and, or performance information

that is generated from the use of a device. Clinical data are sourced

from

(a) any clinical investigation of the device concerned; or

(b) any clinical investigation or other study reported in the

scientific literature, of a similar device for which

equivalence to the device in question can be

demonstrated; or

(c) published and, or unpublished reports on other clinical

experience of either the device in question or a similar

device for which equivalence to the device in question

can be demonstrated;

"the Community" means the European Community;

"custom-made device" means any device specifically made in

accordance with a duly qualified medical practitioner’s written

prescription which gives, under his responsibility, specific design

characteristics and is intended for the sole use of a particular

patient. The prescription may also be made out by any other person

authorised by virtue of his professional qualifications to do so.

Mass-produced devices which need to be adapted to meet the

specific requirements of the medical practitioner or any other

professional user shall not be considered to be custom-made

devices;

"derivative" means a material obtained from an animal tissue by

a manufacturing process such as collagen, gelatine, monoclonal

antibodies;

"device intended for clinical investigation" means any device

intended for use by a duly qualified medical practitioner when

conducting investigations, as referred to in Schedule X, in an

adequate human clinical environment. For the purpose of

conducting clinical investigation, any other person who, by virtue

of his professional qualifications, is authorised to carry out such

investigation shall be accepted as equivalent to a duly qualified

medical practitioner;

"device subcategory" means a set of devices having common

areas of intended use or common technology;

"generic device group" means a set of devices having the same or

similar intended uses or commonality of technology allowing them

to be classified in a generic manner not reflecting specific

characteristics;

"Harmonised Standard" means a technical specification adopted

by the European Committee for Standardisation (CEN) or the

E u r o p e a n C o m m i t t e e f o r E l e c t r o t e c h n i c a l St a n d a r d i s a t i o n

(CENELEC) or the European Telecommunications Standards

Institute (ETSI), upon a remit from the European Commission in

accordance with the Notification Procedure Regulations;

"inactivation" means a process by which the ability to cause

infection or pathogenic reaction by transmissible agents is reduced;

"in vitro diagnostic medical device" means any medical device

which is a reagent, reagent product, calibrator, control material, kit,

instrument, apparatus, equipment or system, whether used alone or

in combination, intended by the manufacturer to be used in vitro for

the examination of specimens, including blood and tissue

donations, derived from the human body, solely or principally for

the purpose of providing information

(a) concerning a physiological or pathological state, or

(b) concerning a congenital abnormality, or

(c) to determine the safety and compatibility with

potential recipients, or

(d) to monitor therapeutic measures;

"specimen receptacles" are those devices, whether vacuum-type

or not, specifically intended by their manufacturers for the primary

containment and preservation of specimens derived from the

human body for the purpose of in vitro diagnostic examination. For

the purposes of these regulations, specimen receptacles are

considered to be in vitro diagnostic medical devices. Products for

general laboratory use are not in vitro diagnostic medical devices

unless such products, in view of their characteristics, are

specifically intended by their manufacturer to be used for in vitro

diagnostic examination;

"intended purpose" means the use for which the device is

intended according to the data supplied by the manufacturer on the

labelling, in the instructions and, or in promotional materials;

"manufacturer" means the natural or legal person with

responsibility for the design, manufacture, packaging and labeling

of a device before it is placed on the market under his own name,

regardless of whether these operations are carried out by that

person himself or on his behalf by a third party

(a) provided that the obligations of these regulations to be

met by manufacturers also apply to the natural or legal

person who assembles, packages, processes, fully

refurbishes and, or labels one or more ready-made

products and, or assigns to them their intended

purpose as a device with a view to their being placed

on the market under his own name;

(b) provided further that the first proviso to this definition

does not apply to the person who, while not a

manufacturer within the meaning of this definition,

assembles or adapts devices already on the market to

their intended purpose for an individual patient;

"medical device" means any instrument, apparatus, appliance,

software, material or other article, whether used alone or in

combination, including the software intended by its manufacturer

to be used specifically for diagnostic and, or therapeutic purposes

and necessary for its proper application, intended by the

manufacturer to be used for human beings for the purpose of -

(a) diagnosis, prevention,

monitoring,

treatment

or

alleviation of disease,

(b) diagnosis, monitoring, treatment, alleviation of or

compensation for an injury or handicap,

(c) investigation, replacement or modification of the

anatomy or of a physiological process,

(d) control of conception,

and which does not achieve its principal intended action in or on

the human body by pharmacological, immunological or metabolic

means, but which may be assisted in its function by such means;

"medical device manufactured utilising tissues of animal origin"

means medical devices manufactured utilising animal tissue which

is rendered non-viable or non-viable products derived from animal

tissue. This definition does not apply to medical devices

manufactured utilising tissues of animal origin which are not

intended to come into contact with the human body or which are

intended to come into contact with intact skin only;

"Medicines Authority" means the Authority as established under

article 4 of the Medicines Act;

"National Standard transposing the Harmonised Standard" means

a Standard issued by one of the members of CEN/CENELEC/ETSI

which is declared and noted to be identical to the Harmonised

Standard originally issued by CEN/CENELEC/ETSI;

"non-viable" means having no potential for metabolism or

multiplication;

"notified body" means a body notified to the Commission and to

the Member States of the Community, assessed according to the

criteria laid down in Schedule XI and appointed to carry out the

procedures referred to in regulations 6(1) to (12). The names of

such bodies are published in the OJ;

"OJ" means the Official Journal of the European Union;

"placing on the market" means the first making available in

return for payment or free of charge of a device other than a device

intended for clinical investigation, with a view to distribution and,

or use on the Community or Maltese market, regardless of whether

it is new or fully refurbished;

"putting into service" means the stage at which a device has been

made available to the final user as being ready for use on the

Community or local market for the first time for its intended

purpose;

"reduction, elimination or removal" means a process by which

the number of transmissible agents is reduced, eliminated or

removed in order to prevent infection or pathogenic reaction;

"single use device" means a device intended to be used once only

for a single patient;

"source country" means the country in which the animal was

born, has been reared and, or has been slaughtered;

"starting materials" means raw materials or any other product of

animal origin out of which, or with the help of which, devices

referred to in the definition for "medical devices manufactured

utilizing tissues of animal origin" are produced;

"tissue" means an organisation of cells and, or extra-cellular

constituents;

"transmissible agents" means unclassified pathogenic entities,

prions and such entities as bovine spongiform encephalopathies

agents and scrapie agents;

"TSE certificate" means the TSE certificate of suitability issued

by the European Directorate for the Quality of Medicines.

(1) The provisions of these regulations are applicable to all

imported medical devices as well as to those manufactured for the

local or Community market.

(2) Where a device is intended to administer a medicinal

product within the meaning of article 2 of the Medicines Act, that

device shall be governed by these regulations, without prejudice to

the provisions of the Medicines Act with regard to the medicinal

MEDICAL DEVICES

product

Provided that

(a) if such a device is placed on the market in such a way

that the device and the medicinal product form a single

integral product which is intended exclusively for use

in the given combination and which is not reusable,

that single product shall be governed by the Medicines

Act; and

(b) the relevant essential requirements of Schedule I shall

apply as far as safety and performance-related device

features are concerned.

(3)

(a) Where a device incorporates, as an integral part, a

substance which, if used separately, may be considered

to be a medicinal product within the meaning of article

2 of the Medicines Act and which is liable to act upon

the body with action ancillary to that of the device, that

device shall be assessed and authorised in accordance

with these regulations.

(b) Where a device incorporates, as an integral part, a

substance which, if used separately, may be considered

to be a medicinal product constituent or a medicinal

product derived from human blood or human plasma

within the meaning of article 2 of the Medicines Act

and which is liable to act upon the human body with

action ancillary to that of the device, hereinafter

referred to as a human blood derivative, that device

shall be assessed and authorised in accordance with

these regulations.

(4) Subject to the definition of a "medical device manufactured

utilising tissues of animal origin" in article 3, no person shall place

on the Maltese or Community market or put into service a device

manufactured utilising either animal tissue which is rendered non-

viable or non-viable products derived from animal tissues unless

(a) there is, in respect of that device, a risk analysis and

risk management scheme which is in accordance with

the requirements of these regulations, in particular

regulations 7(1) to (10) and Schedule XIII; and

(b) the manufacturer of the device has fulfilled his

obligations under the procedures within that scheme.

(5)

These regulations shall not apply to

(a) in vitro diagnostic devices, as defined in the definition

for "in vitro diagnostic medical device" in article 3;

(b) active implantable devices covered by Directive 90/

385/EEC, as implemented by the Active Implantable

Medical Devices Regulations;

(c) medicinal products covered by the Medicines Act. In

deciding whether a product falls under that Directive

or these regulations, particular account shall be taken

of the principal mode of action of the product;

(d) cosmetic products covered by the Cosmetic Products

Regulations;

(e) human blood, blood products, plasma or blood cells of

human origin or to devices which incorporate at the

time of placing on the market such blood products,

plasma or cells, with the exception of devices referred

to in regulation 4(3)(b);

(f)

transplants or tissues or cells of human origin nor to

product incorporating or derived from tissues or cells

of human origin, with the exception of devices

referred to in regulation 4(3)(b);

(g) transplants or tissues or cells of animal origin, unless a

device is manufactured utilising animal tissue which is

rendered non-viable or non-viable products derived

from animal tissue.

(6) Where a device is intended by the manufacturer to be used

in accordance with both the provisions on personal protective

equipment in the Personal Protective Equipment Regulations and

these regulations, the relevant basic health and safety requirements

of the Personal Protective Equipment Regulations shall also be

fulfilled.

(7) These regulations constitute a specific directive within the

meaning of regulation 4(5) of the Electromagnetic Compatibility

Regulations.

(8) These regulations shall not affect the application of the

Nuclear Safety and Radiation Protection Regulations, nor of the

Ionising Radiation Medical Exposure Control Regulations.

(1) The devices must meet the essential requirements set

out in Schedule I which apply to them, taking account of the

intended purpose of the devices concerned.

(2) All necessary steps shall be taken to ensure that devices

may be placed on the market and, or put into service only if they

comply with the requirements laid down in these regulations when

duly supplied and properly installed, maintained and used in

accordance with their intended purpose

(a) Where a relevant hazard exists, devices which are also

machinery within the meaning of regulation 3.1.1 of

the Machinery Regulations, shall also meet the

essential health and safety requirements set out in

Schedule I to the extent to which those essential health

and safety requirements are more specific than the

essential requirements set out in Schedule I.

(b) All necessary steps shall be taken to ensure that

devices referred to in the definition for "medical

device manufactured utilising tissues of animal origin"

in article 3 are placed on the market and put into

service only if they comply with the provisions of

these regulations and with the specifications laid down

in Schedule XIII.

(3) Devices, other than devices which are custom-made or

intended for clinical investigations, considered to meet the

essential requirements referred to in sub-regulation (1) must bear

the CE marking of conformity when they are placed on the market.

(4) The CE marking of conformity, as shown in Schedule XII,

must appear in a visible, legible and indelible form on the device or

its sterile pack, where practicable and appropriate, and on the

instructions for use. Where applicable, the CE marking must also

appear on the sales packaging. The CE marking shall be

accompanied by the identification number of the notified body

responsible for implementation of the procedures set out in

Schedules II, IV, V and VI.

(5) It is prohibited to affix marks or inscriptions which are

likely to mislead third parties with regard to the meaning or the

graphics of the CE marking. Any other mark may be affixed on the

device, to the packaging or to the instruction leaflet accompanying

the device provided that the visibility and legibility of the CE

marking is not thereby reduced.

(6)

(a) Compliance with the essential requirements referred to

in sub-regulation (1) shall be presumed in respect of

devices which are in conformity with the relevant

national standards adopted pursuant to the harmonised

standards the references of which have been published

in the OJ.

(b) For the purposes of these regulations, reference to

harmonised standards also includes the monographs of

the European Pharmacopoeia notably on surgical

sutures and on interaction between medicinal products

and materials used in devices containing such

medicinal products, the references of which have been

published in the OJ.

(7) Where the devices are subject to other Directives

concerning other aspects and which also provide for the affixing of

the CE marking, the latter shall indicate that the devices also fulfil

the provisions of the other Directives

Provided that should one or more of these Directives allow

the manufacturer, during a transitional period, to choose which

arrangements to apply, the CE marking shall indicate that the

devices fulfil the provisions only of those Directives applied by the

manufacturer. In this case, the particulars of these Directives, as

published in the OJ, must be given in the documents, notices or

instructions required by the Directives and accompanying such

devices.

(8) No obstacle shall be created to the placing on the market or

the putting into service of devices bearing the CE marking provided

for in sub-regulations (3) to (5) which indicate that they have been

the subject of an assessment of their conformity in accordance with

the provisions of regulation 6(1) to (12).

(9)

No obstacle shall be created to

(a) devices intended for clinical investigation being made

available to medical practitioners or authorised

persons for that purpose if they meet the conditions

laid down in regulation 9(1) to (8) and in Schedule

VIII; and

(b) custom-made devices being placed on the market and

put into service if they meet the conditions laid down

in regulation 6(1) to (12) in combination with

Schedule VIII; Class IIa, IIb and III devices shall be

accompanied by the statement referred to in Schedule

VIII, which shall be available to the particular patient

identified by name, an acronym or a numerical code.

Such devices shall not bear the CE marking.

(10) At trade fairs, exhibitions and demonstrations, no obstacle

shall be created to the showing of devices which do not conform to

these regulations, provided that a visible sign clearly indicates that

such devices cannot be marketed or put into service until they have

been made to comply.

(11) When a device reaches the final user, regardless of whether

it is for professional or other use, the information which must be

made available to the user and the patient in accordance with

section 13 of Schedule I, shall be provided in, at least, the Maltese

or English language.

(1) In the case of devices falling within Class III, other

than devices which are custom-made or intended for clinical

investigations, the manufacturer shall, in order to affix the CE

marking, either

(a) follow the procedure relating to the EC declaration of

conformity set out in Schedule II relating to full

quality assurance system; or

(b) follow the procedure relating to the EC type-

examination set out in Schedule III, coupled with

(i)

the procedure relating to the EC verification set

out in Schedule IV; or

(ii) the procedure relating to the EC declaration of

conformity set out in Schedule V relating to

production quality assurance.

(2) In the case of devices falling within Class IIa, other than

devices which are custom-made or intended for clinical

investigations, the manufacturer shall, in order to affix the CE

marking, follow the procedure relating to the EC declaration of

conformity set out in Schedule VII, coupled with either

(a) the procedure relating to the EC verification set out in

Schedule IV; or

(b) the procedure relating to the EC declaration of

conformity set out in Schedule V relating to

production quality assurance;

(c) the procedure relating to the EC declaration of

conformity set out in Schedule VI relating to product

quality assurance.

Instead of applying these procedures, the manufacturer may

also follow the procedure referred to in sub-regulation (3)(a).

(3) In the case of devices falling within Class IIb, other than

devices which are custom-made or intended for clinical

investigations, the manufacturer shall, in order to affix the CE

marking, either

(a) follow the procedure relating to the EC declaration of

conformity set out in Schedule II relating to full

quality assurance; in this case, section 4 of Schedule II

is not applicable; or

(b) follow the procedure relating to the EC type-

examination set out in Schedule III, coupled with

(i)

the procedure relating to the EC verification set

out in Schedule IV; or

(ii) the procedure relating to the EC declaration of

conformity set out in Schedule V relating to

production quality assurance; or

(iii) the procedure relating to the EC declaration of

conformity set out in Schedule VI relating to

product quality assurance.

(4) In the case of devices falling within Class I, other than

devices which are custom-made or intended for clinical

investigations, the manufacturer shall, in order to affix the CE

marking, follow the procedure referred to in Schedule VII and draw

up the EC declaration of conformity required before placing the

device on the market.

(5) In the case of custom-made devices, the manufacturer shall

follow the procedure referred to in Schedule VIII and draw up the

statement set out in that Schedule before placing each device on the

market.

The manufacturer of such devices may be requested to

submit a list of devices which have been into service in Malta to the

Medicines Authority.

(6) During the conformity assessment procedure for a device,

the manufacturer and, or the notified body shall take account of the

results of any assessment and verification operations which, where

appropriate, have been carried out in accordance with these

regulations at an intermediate stage of manufacture.

(7) The

manufacturer

may

instruct

his

authorised

representative to initiate the procedures provided for in Schedules

III, IV, VII and VIII.

(8) Where the conformity assessment procedure involves the

intervention of a notified body, the manufacturer, or his authorised

representative, may apply to a body of his choice within the

framework of the tasks for which the body has been notified.

(9) The notified body may require, where duly justified, any

information or data, which is necessary for establishing and

maintaining the attestation of conformity in view of the chosen

procedure.

(10) Decisions taken by the notified bodies in accordance with

Schedules II, III, V and VI shall be valid for a maximum of five

years and may be extended on application, made at a time agreed in

the contract signed by both parties, for further periods of a

maximum length of five years.

(11) The records and correspondence relating to the procedures

referred to in sub-regulations (1) to (5) shall be in the Maltese or

English language or in another Community language acceptable to

the notified body.

(12) By derogation from sub-regulations (1) to (5), the

Medicines Authority, after consulting the Superintendent of Public

Health, may authorise, on duly justified request, the placing on the

market and putting into service, within the Maltese territory, of

individual devices for which the procedures referred to in sub-

regulations (1) to (5) have not been carried out and the use of which

is in the interest of protection of health.

(1) With respect to medical devices referred to in the

definition for "medical device manufactured utilising tissues of

animal origin" in article 3, the following regulations shall apply in

addition to the provisions mentioned in regulation 6(1) to (12) that

apply to them.

(2) Collagen, gelatine or tallow used for the manufacturing of

medical devices, shall meet at least the requirements as fit for

human consumption.

(3) All necessary steps shall be taken to ensure that devices

referred to in the definition in sub-regulation (1) are placed on the

market and put into service only if they comply with the provisions

of these regulations and the specifications laid down in Schedule

XIII.

(4) Conformity assessment procedures for medical devices

referred to in the definition in sub-regulation (1) shall include the

evaluation of their compliance with the essential requirements laid

down in Schedule I and the specifications laid down in Schedule

XIII.

(5) Before lodging an application for a conformity assessment

pursuant to regulation 6(1), the manufacturer of medical devices

referred to in the definition in sub-regulation (1) shall carry out the

risk analysis and the risk management scheme set out in Schedule

XIII.

(6) In order to assess the conformity of devices referred to the

definition in sub-regulation (1) with the provisions of these

regulations and with the specifications laid down in Schedule XIII,

the Medicines Authority shall verify that bodies notified under

regulations 13(1) to (8) have up-to-date knowledge of these

devices. If, on the basis of that verification, it is necessary to

amend the tasks of a notified body, the Medicines Authority shall

notify the Commission and other Member States accordingly.

(7) Notified bodies shall evaluate the manufacturer’s risk

analysis and risk management strategy, and in particular

(a) the information provided by the manufacturer;

(b) the justification for the use of animal tissues or

derivatives;

(c) the results of elimination and, or inactivation studies

or of literature search;

(d) the manufacturer’s control of the sources of raw

materials, finished products and subcontractors;

(e) the need to audit matters related to sourcing, including

third party supplies.

(8) Notified bodies shall, during the evaluation of the risk

analysis and risk management in the framework of the conformity

assessment procedure, take account of the TSE certificate of

suitability referred to in the definition for "TSE certificate" in

article 3, for starting materials, where available.

(9) Except for medical devices using starting materials for

which a TSE certificate has been issued as referred to in sub-

regulation (8), national bodies shall, through the Regulatory Affairs

Directorate, seek the opinion of the competent authorities of the

other Member States on their evaluation of and conclusions on the

risk analysis and risk management of the tissues or the derivatives

intended to be incorporated in the medical device as established by

the manufacturer.

(10) Before issuing an EC design-examination certificate or an

EC type-examination certificate, the notified bodies shall give due

consideration to any comments received within twelve weeks from

the date on which the opinion of the national competent authorities

was sought.

(1) By way of derogation from regulations 6(1) to (12), the

following sub-regulations shall apply to systems and procedure

packs.

(2) Any natural or legal person who puts devices bearing the

CE marking together within their intended purpose and within the

limits of use specified by their manufacturers, in order to place

them on the market as a system or procedure pack, shall draw up a

declaration by which he states that

(a) he has verified the mutual compatibility of the devices

in accordance with the manufacturers’ instructions and

has carried out his operations in accordance with these

instructions; and

(b) he has packaged the system or procedure pack and

supplied relevant information to users incorporating

relevant instructions from the manufacturers; and

(c) the whole activity is subjected to appropriate methods

of internal control and inspection.

(3) Where the conditions above are not met, as in cases where

the system or procedure pack incorporate devices which do not

bear a CE marking or where the chosen combination of devices is

not compatible in view of their original intended use, the system or

procedure pack shall be treated as a device in its own right and as

such be subjected to the relevant procedure pursuant to regulation

6(1) to (12).

(4) Any natural or legal person who sterilises, for the purpose

of placing on the market, systems or procedure packs referred to in

sub-regulations (2) and (3) or other CE-marked medical devices

designed by their manufacturers to be sterilised before use, shall, at

his choice, follow one of the procedures referred to in Schedule II

or Schedule V. The application of the above-mentioned Schedules

and the intervention of the notified body are limited to the aspects

of the procedure relating to the obtaining of sterility until the

sterile package is opened or damaged. The person shall draw up a

declaration stating that sterilisation has been carried out in

accordance with the manufacturer’s instructions.

(5) The products referred to in sub-regulations (2) to (4) shall

not themselves bear an additional CE marking. They shall be

accompanied by the information referred to in section 13 of

Schedule I which includes, where appropriate, the information

supplied by the manufacturers of the devices which have been put

together. The declarations referred to in sub-regulations (2) to (4)

shall be kept at the disposal of the Medicines Authority for a period

of five years.

(1) In the case of devices intended for clinical

investigations to be conducted in Malta, the manufacturer or the

authorised representative shall follow the procedure referred to in

Schedule VIII and notify the Medicines Authority by means of the

statement mentioned in section 2(b) of Schedule VIII.

(2)

(a) In the case of devices falling within Class III and

implantable and long-term invasive devices falling

within Class IIa or IIb, the manufacturer may

commence the relevant clinical investigation at the end

of a period of sixty days after notification, unless the

Medicines Authority have notified him within that

period of a decision to the contrary based on

considerations of public health or public policy.

(b) However, manufacturers may be authorised by the

Medicines Authority to commence the relevant clinical

investigations before the expiry of the period of sixty

days, in so far as the Ethics Committee, established by

the Clinical Trials Regulations, has issued a

favourable opinion on the programme of investigation

in question, including its review of the clinical

investigation plan.

(3) In the case of devices other than those referred to in sub-

regulation (2), manufacturers may be authorised by the Medicines

Authority to commence clinical investigations immediately after

the date of notification, provided that the Ethics Committee

mentioned above has issued a favourable opinion on the

programme of investigation in question including its review of the

clinical investigation plan.

(4)

The

clinical

investigations

must

be

conducted

in

accordance with the provision of Schedule X.

(5)

(a) If necessary, any appropriate steps to ensure public

health and public policy shall be taken according to the

Public Health Act.

(b) Where a clinical investigation is refused or halted, the

Medicines Authority shall communicate such decision

and the grounds thereof to all Member States and the

Commission. Where a significant modification or

temporary interruption of a clinical investigation has

been called, the Medicines Authority shall inform the

Member States concerned about such actions and the

grounds for the actions taken.

(6)

(a) The manufacturer or his authorised representative shall

notify the Medicines Authority and the competent

authorities of the other Member States concerned of

the end of the clinical investigation, with a

justification in case of early termination.

(b) In the case of early termination of the clinical

investigation on safety grounds, the notification

referred to in paragraph (a) shall be communicated by

the Regulatory Affairs Directorate to all Member

States and the Commission.

(c) The manufacturer or his authorised representative

shall keep the report referred to in section 2(c)(vii) of

Schedule X at the disposal of the Medicines Authority

and the competent authorities of the other Member

States concerned.

(7) The provisions of sub-regulations (1) and (2) do not apply

where the clinical investigations are conducted using devices which

are authorised in accordance with regulation 6(1) to (12) to bear the

CE marking unless the aim of these investigations is to use the

devices for a purpose other than that referred to in the relevant

conformity assessment procedure. The relevant provisions of

Schedule X remain applicable.

(1) Where it is ascertained that the devices referred to in

regulation 5(8) and (9)(b), when correctly installed, maintained and

used for their intended purpose, may compromise the health and, or

safety of patients, users or, where applicable, other persons, all

appropriate interim measures shall be taken by the Medicines

Authority to withdraw such devices from the market or prohibit or

restrict their being placed on the market or put into service.

(2) If a device which is not in conformity with the relevant

requirements bears the CE marking, all appropriate measures shall

be taken with regard to those responsible for affixing the marking.

(3) The Medicines Authority shall take the necessary steps to

ensure that any information brought to his knowledge, in

accordance with the provisions of these regulations, regarding the

incidents mentioned below involving a Class I, IIa, IIb or III device

is recorded and evaluated centrally

(a) any malfunction or deterioration in the characteristics

and, or performance of a device, as well as any

inadequacy in the labelling or the instructions for use

which might lead to or might have led to the death of a

patient or user or to a serious deterioration in his state

of health;

(b) any technical or medical reason in relation to the

characteristics or performance of a device for the

reasons referred to in paragraph (a), leading to a

systematic recall of devices of the same type by the

manufacturer.

(4) The Medicines Authority shall be immediately informed of

a n y s u c h m e a s u r e s t ak en u n d e r s u b - r e g u l a t i o n s ( 1 ) t o ( 3 ) ,

indicating the reasons for such decision and, in particular, whether

non-compliance is due to

(a) failure to satisfy the essential requirements referred to

in regulation 5(1);

(b) incorrect application of the standards referred to in

regulation 5(6), in so far as it is claimed that the

standards have been applied;

(c) shortcomings in the standards themselves.

(5)

(a) The necessary steps shall be taken to ensure that the

manufacturer of the device concerned, or his

authorised representative, is also informed of the

incidents referred to in sub-regulation (3).

(b) An assessment of the incidents mentioned in sub-

regulation (3) will be carried out by the Medicines

Authority, if possible together with the manufacturer

or his authorised representative.

(6)

Any decision taken pursuant to these regulations -

(a) to refuse or restrict the placing on the market or the

putting into service of a device or the carrying out of

clinical investigations; or

(b) to withdraw devices from the market,

shall state the exact grounds on which it is based. Such decisions

shall be notified without delay to the party concerned, who shall at

the same time be informed of the remedies available to him under

the Maltese law and of the time limits to which such remedies are

subject.

(7) In the event of a decision as referred to in sub-regulation

(6), the manufacturer shall have an opportunity to put forward his

viewpoint in advance, unless such consultation is not possible

because of the urgency of the measure to be taken.

(8) Where the Medicines Authority considers, in relation to a

given product or group of products, that, in order to ensure the

protection of health and safety and, or to ensure that public health

requirements are observed, such products should be withdrawn

from the market, or their placing on the market and putting into

service should be prohibited, restricted or subjected to particular

requirements, any necessary and justified transitional measures

may be taken.

The Medicines Authority shall immediately inform the Commission

and all other Member States of any measures taken in pursuance of

sub-regulations (1) to (10), giving the reasons for such decisions..

(9)

Without prejudice to sub-regulations (1), (2) and (4)

(a) where it is established that the CE marking has been

affixed unduly or is missing in violation of these

regulations, the manufacturer or his authorised

representative shall be obliged to end the infringement

under conditions imposed by the Medicines Authority;

and

(b) where non-compliance continues, all appropriate

measures shall be taken by the Medicines Authority to

restrict or prohibit the placing on the market of the

product in question or to ensure that it is withdrawn

from the market, in accordance with the procedure as

laid down in sub-regulations (1), (2) and (4).

(10) The provisions of sub-regulation (9) shall also apply where

the CE marking has been affixed in accordance with the procedures

in these regulations, but inappropriately, on products that are not

covered by these regulations.

11.(1)(a) Any manufacturer who has his registered place of

business in Malta and, under his own name, places

devices on the market in accordance with the

procedures referred to in regulation 6(4) and (5) and

any other natural or legal person engaged in the

activities referred to in regulation 8(1) to (5) shall

inform the Medicines Authority of his registered place

of business and the description of the devices

concerned.

(b) For all medical devices of Classes IIa, IIb and III, all

data allowing the identification of such devices

together with the label and instructions for use, may be

requested when such devices are put into service in

Malta.

(2)

(a) Where a manufacturer who places a device on the

Maltese or Community market under his own name

does not have a registered place of business in a

Member State, he shall designate a single authorised

representative in the European Union.

(b) When the authorised representative referred to herein

has a registered place of business in Malta, he shall

inform the Regulatory Affairs Directorate of the

details referred to in sub-regulation (1).

(3) The Medicines Authority shall, on request, inform the other

Member States and the Commission of the details referred to in

sub-regulations (1) and (2) given by the manufacturer or authorised

representative.

(1) Regulatory data in accordance with these regulations

shall be stored in a European databank accessible to the competent

authorities to enable them to carry out their tasks relating to these

regulations on a well-informed basis. The databank shall contain

the following

(a) data relating to registration of manufacturers and

authorised representatives and devices in accordance

with regulation 11(1) to (3), excluding data related to

custom-made devices;

(b) data relating to certificates issued, modified,

supplemented, suspended, withdrawn or refused

according to the procedures, as laid down in Schedules

II to VII;

(c) data obtained in accordance with the vigilance

procedure as defined in regulations 10(3) and (5);

(d) data relating to clinical investigations referred to in

regulation 9(1) to (8).

(2) Data shall be forwarded in a standardised format by the

Medicines Authority.

(3) The provisions of sub-regulations (1) and (2) shall be

implemented not later than 5th September 2012.

(1) The Medicines Authority shall notify the Commission

and other Member States of the bodies which it has designated for

carrying out the tasks pertaining to the procedures referred to in

regulation 6(1) to (12) and the specific tasks for which the bodies

have been designated.

(2) The Medicines Authority shall apply the criteria set out in

Schedule XI for the designation of bodies. Bodies that meet the

criteria laid down in the national standards which transpose the

relevant harmonised standards shall be presumed to meet the

relevant criteria.

(3) The Medicines Authority shall withdraw the notification

referred to in sub-regulation (1) if it finds that the body no longer

meets the criteria referred to i n sub-regulation (2). It shall

immediately inform the other Member States and the Commission

thereof.

(4) The notified body and the manufacturer, or his authorised

representative, shall lay down, by common accord, the time limits

for completion of the assessment and verification operations

referred to in Schedules II to VI.

(5)

(a) The notified body shall inform the Regulatory Affairs

Directorate about all certificates issued, modified,

supplemented, suspended, withdrawn or refused and

the other notified bodies within the scope of these

regulations about certificates suspended, withdrawn or

refused and, on request, about certificates issued.

(b) The notified body shall also make available, on

request, all additional relevant information.

(6)

(a) Where a notified body finds that pertinent

requirements of these regulations have not been met or

are no longer met by the manufacturer or where a

certificate should not have been issued, it shall, taking

account of the principle of proportionality, suspend or

withdraw the certificate issued or place any restrictions

on it unless compliance with such requirements is

ensured by the implementation of appropriate

corrective measures by the manufacturer.

(b) In the case of suspension or withdrawal of the

certificate or of any restriction placed on it or in cases

where an intervention of the competent authority may

become necessary, the notified body shall inform the

Regulatory

Affairs

Directorate

thereof.

The

Regulatory Affairs Directorate shall inform the other

Member States and the Commission.

(7) The notified body shall, on request, supply all relevant

information and documents including budgetary documents,

required to enable the Regulatory Affairs Directorate to verify

c om p l i a n c e w i t h t h e r e q ui r e m en ts o f S c h e d u l e XI t o t h e s e

regulations.

(8) All necessary actions shall be taken to ensure that the

notified bodies which are responsible pursuant to regulation 6(1) to

(4) for conformity assessment take account of any relevant

information regarding the characteristics and performance of such

devices, including in particular the results of any relevant tests and

verification already carried out under pre-existing Maltese law,

regulations or administrative provisions in respect of such devices.

(1) Without prejudice to the existing national provisions and

practices on medical secrets, the Medicines Authority shall ensure that

all the parties involved in the application of these regulations are

bound to observe confidentiality with regard to all information

obtained in carrying out their tasks. This does not affect the obligation

of the Medicines Authority with regard to mutual information and the

dissemination of warnings, nor the obligation of the persons concerned

to provide information under criminal law.

(2) The following information shall not be treated as

confidential

(a) information on the registration of persons responsible

for placing devices on the market in accordance with

regulation 11(1) to (3);

(b) information to users sent out by the manufacturer,

authorised representative or distributor in relation to a

measure according to regulation 10(5)(b);

(c) information contained in certificates issued, modified,

supplemented, suspended or withdrawn.

Deleted by Legal Notice 320 of 2020.

Schedule I

Based on Annex I of Directive 93/42/EEC

ESSENTIAL REQUIREMENTS

I

GENERAL REQUIREMENTS

(1) The devices must be designed and manufactured in such a way that, when

used under the conditions and for the purposes intended, they will not compromise

the clinical condition or the safety of patients, or the safety and health of users or,

where applicable, other persons, provided that any risks which may be associated

with their intended use constitute acceptable risks when weighed against the benefits

to the patient and are compatible with a high level of protection of health and safety.

This shall include

(a) reducing, as far as possible, the risk of use error due to the ergonomic

features of the device and the environment in which the device is

intended to be used (design for patient safety), and

(b) consideration of the technical knowledge, experience, education and

training and where applicable the medical and physical conditions of

intended users (design for lay, professional, disabled or other users).

(2) The solutions adopted by the manufacturer for the design and construction

of the devices must conform to safety principles, taking account of the generally

acknowledged state of the art. In selecting the most appropriate solutions, the

manufacturer must apply the following principles in the following order

(a) eliminate or reduce risks as far as possible (inherently safe design and

construction),

(b) where appropriate take adequate protection measures including alarms

if necessary, in relation to risks that cannot be eliminated,

(c) inform users of the residual risks due to any shortcomings of the

protection measures adopted.

(3) The devices must achieve the performances intended by the manufacturer

and be designed, manufactured and packaged in such a way that they are suitable for

one or more of the functions referred to in the definition of a “medical device” in

regulation 3, as specified by the manufacturer.

(4) The characteristics and performances referred to in sections 1, 2 and 3 of

this Schedule must not be adversely affected to such a degree that the clinical

conditions and safety of the patients and, where applicable, of other persons are

compromised during the lifetime of the device as indicated by the manufacturer,

when the device is subjected to the stresses which can occur during normal

conditions of use.

(5) The devices must be designed, manufactured and packed in such a way that

their characteristics and performances during their intended use will not be

adversely affected during transport and storage taking account of the instructions

and information provided by the manufacturer.

(6)

(a) Any undesirable side-effect must constitute an acceptable risk when

weighed against the performances intended.

(b) Demonstration of conformity with the essential requirements must

include a clinical evaluation in accordance with Schedule X to these

regulations.

II

REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

(7)

Chemical, physical and biological properties

(a) The devices must be designed and manufactured in such a way as to

guarantee the characteristics and performances referred to in section I

of this Schedule on the ‘General Requirements’. Particular attention

must be paid to

(i)

the choice of materials used, particularly as regards toxicity and,

where appropriate, flammability,

(ii) the compatibility between the materials used and biological

tissues, cells and body fluids, taking account of the intended

purpose of the device,

(iii) where appropriate, the results of biophysical or modelling

research whose validity has been demonstrated beforehand.

(b) The devices must be designed, manufactured and packed in such a way

as to minimize the risk posed by contaminants and residues to the

persons involved in the transport, storage and use of the devices and to

the patients, taking account of the intended purpose of the product.

Particular attention must be paid to the tissues exposed and to the

duration and frequency of exposure.

(c) The devices must be designed and manufactured in such a way that they

can be used safely with the materials, substances and gases with which

they enter into contact during their normal use or during routine

procedures; if the devices are intended to administer medicinal products

they must be designed and manufactured in such a way as to be

compatible with the medicinal products concerned according to the

provisions and restrictions governing these products and that their

performance is maintained in accordance with the intended use.

(d) Where a device incorporates, as an integral part, a substance which, if

used separately, may be considered to be a medicinal product as defined

in article 2 of the Medicines Act and which is liable to act upon the

body with action ancillary to that of the device, the quality, safety and

usefulness of the substance must be verified by analogy with the

methods specified in Annex I to Directive 2001/83/EC.

(i)

For the substances referred to in the first paragraph, the notified

body shall, having verified the usefulness of the substance as part

of the medical device and taking account of the intended purpose

of the device, seek a scientific opinion from one of the competent

authorities designated by the Member States or the European

Medicines Agency (EMEA) acting particularly through its

committee in accordance with Regulation (EC) No 726/2004 * on

the quality and safety of the substance including the clinical

benefit and risk profile of the incorporation of the substance into

the device. When issuing its opinion, the competent authority or

the EMEA shall take into account the manufacturing process and

the data related to the usefulness of incorporation of the substance

into the device as determined by the notified body.

(ii) Where a device incorporates, as an integral part, a human blood

derivative, the notified body shall, having verified the usefulness

of the substance as part of the medical device and taking into

*Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying

down Community procedures for the authorisation and supervision of medicinal products for human and

veterinary use and establishing a European Medicines Agency (OJ L.136)

account the intended purpose of the device, seek a scientific

opinion from the EMEA, acting particularly through its

committee, on the quality and safety of the substance including

the clinical benefit and risk profile of the incorporation of the

human blood derivative into the device. When issuing its opinion,

the EMEA shall take into account the manufacturing process and

the data related to the usefulness of incorporation of the substance

into the device as determined by the notified body.

(iii) Where changes are made to an ancillary substance incorporated in

a device, in particular related to its manufacturing process, the

notified body shall be informed of the changes and shall consult

the relevant medicines competent authority (the one involved in

the initial consultation), in order to confirm that the quality and

safety of the ancillary substance are maintained. The competent

authority shall take into account the data related to the usefulness

of incorporation of the substance into the device as determined by

the notified body, in order to ensure that the changes have no

negative impact on the established benefit and risk profile of the

addition of the substance in the medical device.

(iv) When the relevant medicines competent authority (the one

involved in the initial consultation) has obtained information on

the ancillary substance, which could have an impact on the

established benefit and risk profile of the addition of the

substance in the medical device, it shall provide the notified body

with advice, whether this information has an impact on the

established benefit and risk profile of the addition of the

substance in the medical device or not. The notified body shall

take the updated scientific opinion into account in reconsidering

its assessment of the conformity assessment procedure.

(e) The devices must be designed and manufactured in such a way as to

reduce to a minimum the risks posed by substances leaking from the

device. Special attention shall be given to substances which are

carcinogenic, mutagenic or toxic to reproduction, in accordance with

the Dangerous Substances (Notification) Regulations.

(i)

If parts of a device (or a device itself) intended to administer and,

or remove medicines, body liquids or other substances to or from

the body, or devices intended for transport and storage of such

body fluids or substances, contain phthalates which are classified

as carcinogenic, mutagenic or toxic to reproduction, of category 1

or 2, in accordance with the Dangerous Substances (Notification)

Regulations, these devices must be labelled on the device itself

and, or on the packaging for each unit or, where appropriate, on

the sales packaging as a device containing phthalates.

(ii) If the intended use of such devices includes treatment of children

or treatment of pregnant or nursing women, the manufacturer

must provide a specific justification for the use of these

substances with regard to compliance with the essential

requirements, in particular of this paragraph, within the technical

documentation and, within the instructions for use, information

on residual risks for these patient groups and, if applicable, on

appropriate precautionary measures.

(f)

Devices must be designed and manufactured in such a way as to reduce,

as much as possible, risks posed by the unintentional ingress of

substances into the device taking into account the device and the nature

of the environment in which it is intended to be used.

(8)

Infection and microbial contamination

(a) The devices and manufacturing processes must be designed in such a

way as to eliminate or reduce as far as possible the risk of infection to

the patient, user and third parties. The design must allow easy handling

and, where necessary, minimize contamination of the device by the

patient or vice versa during use.

(b)

(i)

Tissues of animal origin must originate from animals that have

been subjected to veterinary controls and surveillance adapted to

the intended use of the tissues.

(ii) Notified bodies shall retain information on the geographical

origin of the animals.

(iii) Processing, preservation, testing and handling of tissues, cells and

substances of animal origin must be carried out so as to provide

optimal security. In particular safety with regard to viruses and

other transmissible agents must be addressed by implementation

of validated methods of elimination or viral inactivation in the

course of the manufacturing process.

(c) Devices delivered in a sterile state must be designed, manufactured and

packed in a non-reusable pack and, or according to appropriate

procedures to ensure that they are sterile when placed on the market and

remain sterile, under the storage and transport conditions laid down,

until the protective packaging is damaged or opened.

(d) Devices delivered in a sterile state must have been manufactured and

sterilised by an appropriate, validated method.

(e) Devices intended to be sterilised must be manufactured in appropriately

controlled (e.g. environmental) conditions.

(f)

Packaging systems for non-sterile devices must keep the product

without deterioration at the level of cleanliness stipulated and, if the

devices are to be sterilised prior to use, minimise the risk of microbial

contamination; the packaging system must be suitable taking account of

the method of sterilisation indicated by the manufacturer.

(g) The packaging and, or label of the device must distinguish between

identical or similar products sold in both sterile and non-sterile

condition.

(9)

Construction and environmental properties

(a) If the device is intended for use in combination with other devices or

equipment, the whole combination, including the connection system

must be safe and must not impair the specified performances of the

devices. Any restrictions on use must be indicated on the label or in the

instructions for use.

(b) Devices must be designed and manufactured in such a way as to remove

or minimize as far as is possible

(i)

the risk of injury, in connection with their physical features,

including the volume/pressure ratio, dimensional and where

appropriate ergonomic features,

(ii) risks connected with reasonably foreseeable environmental

conditions, such as magnetic fields, external electrical influences,

electrostatic discharge, pressure, temperature or variations in

pressure and acceleration,

(iii) the risks of reciprocal interference with other devices normally

used in the investigations or for the treatment given,

(iv) risks arising where maintenance or calibration are not possible (as

with implants), from ageing of materials used or loss of accuracy

of any measuring or control mechanism.

(c) Devices must be designed and manufactured in such a way as to

minimize the risks of fire or explosion during normal use and in single

fault condition. Particular attention must be paid to devices whose

intended use includes exposure to flammable substances or to

substances which could cause combustion.

(10) Devices with a measuring function

(a) Devices with a measuring function must be designed and manufactured

in such a way as to provide sufficient accuracy and stability within

appropriate limits of accuracy and taking account of the intended

purpose of the device. The limits of accuracy must be indicated by the

manufacturer.

(b) The measurement, monitoring and display scale must be designed in

line with ergonomic principles, taking account of the intended purpose

of the device.

(c) The measurements made by devices with a measuring function must be

expressed in legal units conforming to the provisions of the Metrology

Act.

(11) Protection against radiation

(a) General

Devices shall be designed and manufactured in such a way that

exposure of patients, users and other persons to radiation shall be

reduced as far as possible compatible with the intended purpose, whilst

not restricting the application of appropriate specified levels for

therapeutic and diagnostic purposes.

(b) Intended radiation

(i)

Where devices are designed to emit hazardous levels of radiation

necessary for a specific medical purpose the benefit of which is

considered to outweigh the risks inherent in the emission, it must

be possible for the user to control the emissions. Such devices

shall be designed and manufactured to ensure reproducibility and

tolerance of relevant variable parameters.

(ii) Where devices are intended to emit potentially hazardous, visible

and, or invisible radiation, they must be fitted, where practicable,

with visual displays and, or audible warnings of such emissions.

(c) Unintended radiation

Devices shall be designed and manufactured in such a way that

exposure of patients, users and other persons to the emission of

unintended, stray or scattered radiation is reduced as far as possible.

(d) Instructions

The operating instructions for devices emitting radiation must give

detailed information as to the nature of the emitted radiation, means of

protecting the patient and the user and on ways of avoiding misuse and

of eliminating the risks inherent in installation.

(e) Ionising radiation

(i)

Devices intended to emit ionizing radiation must be designed and

manufactured in such a way as to ensure that, where practicable,

the quantity, geometry and quality of radiation emitted can be

varied and controlled taking into account the intended use.

(ii) Devices emitting ionizing radiation intended for diagnostic

radiology shall be designed and manufactured in such a way as to

achieve appropriate image and, or output quality for the intended

medical purpose whilst minimizing radiation exposure of the

patient and user.

(iii) Devices emitting ionizing radiation, intended for therapeutic

radiology shall be designed and manufactured in such a way as to

enable reliable monitoring and control of the delivered dose, the

beam type and energy and where appropriate the quality of

radiation.

(12) Requirements for medical devices connected to or equipped with an energy

(a) Devices incorporating electronic programmable systems must be

designed to ensure the repeatability, reliability and performance of these

systems according to the intended use. In the event of a single fault

condition (in the system) appropriate means should be adopted to

eliminate or reduce as far as possible consequent risks.

(b) For devices which incorporate software or which are medical software

in themselves, the software must be validated according to the state of

the art taking into account the principles of development lifecycle, risk

management, validation and verification.

(c) Devices where the safety of the patients depends on an internal power

supply must be equipped with a means of determining the state of the

power supply.

(d) Devices where the safety of the patients depends on an external power

supply must include an alarm system to signal any power failure.

(e) Devices intended to monitor one or more clinical parameters of a patient

must be equipped with appropriate alarm systems to alert the user of

situations which could lead to death or severe deterioration of the

patient's state of health.

(f)

Devices must be designed and manufactured in such a way as to

minimize the risks of creating electromagnetic fields which could

impair the operation of other devices or equipment in the usual

environment.

(g) Protection against electrical risks

Devices must be designed and manufactured in such a way as to avoid,

as far as possible, the risk of accidental electric shocks during normal

use and in single fault condition, provided the devices are installed

correctly.

(h) Protection against mechanical and thermal risks

(i)

Devices must be designed and manufactured in such a way as to

protect the patient and user against mechanical risks connected

with, for example, resistance, stability and moving parts.

(ii) Devices must be designed and manufactured in such a way as to

reduce to the lowest possible level the risks arising from vibration

generated by the devices, taking account of technical progress and

of the means available for limiting vibrations, particularly at

source, unless the vibrations are part of the specified

performance.

(iii) Devices must be designed and manufactured in such a way as to

reduce to the lowest possible level the risks arising from the noise

emitted, taking account of technical progress and of the means

available to reduce noise, particularly at source, unless the noise

emitted is part of the specified performance.

(iv) Terminals and connectors to the electricity, gas or hydraulic and

pneumatic energy supplies which the user has to handle must be

designed and constructed in such a way as to minimize all

possible risks.

(v) Accessible parts of the devices (excluding the parts or areas

intended to supply heat or reach given temperatures) and their

surroundings must not attain potentially dangerous temperatures

under normal use.

(i)

Protection against the risks posed to the patient by energy supplies or

substances

(i)

Devices for supplying the patient with energy or substances must

be designed and constructed in such a way that the flow-rate can

be set and maintained accurately enough to guarantee the safety

of the patient and of the user.

(ii) Devices must be fitted with the means of preventing and, or

indicating any inadequacies in the flow-rate which could pose a

danger.

(iii) Devices must incorporate suitable means to prevent, as far as

possible, the accidental release of dangerous levels of energy

from an energy and, or substance source.

(j)

The function of the controls and indicators must be clearly specified on

the devices.

Where a device bears instructions required for its operation or indicates

operating or adjustment parameters by means of a visual system, such

information must be understandable to the user and, as appropriate, the

patient.

(13) Information supplied by the manufacturer

(a) Each device must be accompanied by the information needed to use it

safely and properly, taking account of the training and knowledge of

potential users, and to identify the manufacturer.

(i)

This information comprises the details on the label and the data in

the instructions for use.

(ii) As far as practicable and appropriate, the information needed to

use the device safely must be set out on the device itself and, or

on the packaging for each unit or, where appropriate, on the sales

packaging. If individual packaging of each unit is not practicable,

the information must be set out in the leaflet supplied with one or

more devices.

(iii) Instructions for use must be included in the packaging for every

device. By way of exception, no such instructions for use are

needed for devices in Class I or IIa if they can be used safely

without any such instructions.

(b) Where appropriate, this information should take the form of symbols.

Any symbol or identification colour used must conform to the

harmonized standards. In areas for which no standards exist, the

symbols and colours must be described in the documentation supplied

with the device.

(c) The label must bear the following particulars

(i)

the name or trade name and address of the manufacturer. For

devices imported in Malta, in view of their distraction locally or

in the Community, the label, or the outer packaging, or

instructions for use, shall contain in addition the name and

address of the authorised representative where the manufacturer

does not have a registered place of business in Malta or in the

Community;

(ii) the details strictly necessary to identify the device and the

contents of the packaging especially for the users;

(iii) where appropriate, the word ‘STERILE’;

(iv) where appropriate, the batch code, preceded by the word ‘LOT’,

or the serial number;

(v) where appropriate, an indication of the date by which the device

should be used, in safety, expressed as the year and month;

(vi) where appropriate, an indication that the device is for single use.

A manufacturer’s indication of single use must be consistent

across the Community;

(vii) if the device is custom-made, the words ‘custom-made device’;

(viii) if the device is intended for clinical investigations, the words

‘exclusively for clinical investigations’;

(ix) any special storage and, or handling conditions;

(x) any special operating instructions;

(xi) any warnings and, or precautions to take;

(xii)

year of manufacture for active devices other than those covered

by section 13(c)(v) of this Schedule. This indication may be

included in the batch or serial number;

(xiii) where applicable, method of sterilisation;

(xiv) in the case of a device within the meaning of regulation 4(3)(b) of

these regulations, an indication that the device contains a human

blood derivative.

(d) If the intended purpose of the device is not obvious to the user, the

manufacturer must clearly state it on the label and in the instructions for

(e) Wherever reasonable and practicable, the devices and detachable

components must be identified, where appropriate in terms of batches,

to allow all appropriate action to detect any potential risk posed by the

devices and detachable components.

(f)

Where appropriate, the instructions for use must contain the following

particulars

(i)

the details referred to in section 13(c) of this Schedule, with the

exception of sections (iv) and (v);

(ii) the performances referred to in section 3 of this Schedule and any

undesirable side-effects;

(iii) if the device must be installed with or connected to other medical

devices or equipment in order to operate as required for its

intended purpose, sufficient details of its characteristics to

identify the correct devices or equipment to use in order to obtain

a safe combination;

(iv) all the information needed to verify whether the device is

properly installed and can operate correctly and safely, plus

details of the nature and frequency of the maintenance and

calibration needed to ensure that the devices operate properly and

safely at all times;

(v) where appropriate, information to avoid certain risks in

connection with implantation of the device;

(vi) information regarding the risks of reciprocal interference posed

by the presence of the device during specific investigations or

treatment;

(vii)

the necessary instructions in the event of damage to the sterile

packaging and, where appropriate, details of appropriate methods

of resterilisation;

(viii) if the device is reusable, information on the appropriate processes

to allow reuse, including cleaning, disinfection, packaging and,

where appropriate, the method of sterilisation of the device to be

resterilised, and any restriction on the number of reuses.

Where devices are supplied with the intention that they be

sterilised before use, the instructions for cleaning and sterilisation

must be such that, if correctly followed, the device will still

comply with the requirements in sections 1 to 6 of this Schedule.

If the device bears an indication that the device is for single use,

information on known characteristics and technical factors known

to the manufacturer that could pose a risk if the device were to be

re-used. If in accordance with section 13(a) of this Schedule no

instructions for use are needed, the information must be made

available to the user upon request;

(ix) details of any further treatment or handling needed before the

device can be used (for example, sterilisation, final assembly,

etc.);

(x)

in the case of devices emitting radiation for medical purposes,

details of the nature, type, intensity and distribution of this

radiation.

The instructions for use must also include details allowing the

medical staff to brief the patient on any contra-indications and

any precautions to be taken. These details should cover in

particular;

(xi)

precautions to be taken in the event of changes in the performance

of the device;

(xii)

precautions to be taken as regards exposure, in reasonably

foreseeable environmental conditions, to magnetic fields, external

electrical influences, electrostatic discharge, pressure or

variations in pressure, acceleration, thermal ignition sources, etc.;

(xiii) adequate information regarding the medicinal product or products

which the device in question is designed to administer, including

any limitations in the choice of substances to be delivered;

(xiv) precautions to be taken against any special, unusual risks related

to the disposal of the device;

(xv) medicinal substances or human blood derivatives incorporated

into the device as an integral part in accordance with section 7(d)

of this Schedule;

(xvi) degree of accuracy claimed for devices with a measuring

function;

(xvii) date of issue or the latest revision of the instructions for use.

Schedule II

Based on Annex II of Directive 93/42/EEC

EC DECLARATION OF CONFORMITY (Full quality assurance system)

(1) The manufacturer must ensure application of the quality system approved

for the design, manufacture and final inspection of the products concerned, as

specified in section 3 and is subject to audit as laid down in sections 3(c) and 4 and

to Community surveillance as specified in section 5 of this Schedule.

(2) The EC declaration of conformity is the procedure whereby the

manufacturer who fulfils the obligations imposed by section 1 of this Schedule

ensures and declares that the products concerned meet the provisions of this

Directive which apply to them.

The manufacturer must affix the CE marking in accordance with regulations 5(3)

to (5) and draw up a written declaration of conformity. This declaration must cover

one or more medical devices manufactured, clearly identified by means of product

name, product code or other unambiguous reference and must be kept by the

(3)

Quality System

(a) The manufacturer must lodge an application for assessment of his

quality system with a notified body. The application must include

(i)

the name and address of the manufacturer and any additional

manufacturing site covered by the quality system,

(ii) all the relevant information on the product or product category

covered by the procedure,

(iii) a written declaration that no application has been lodged with any

other notified body for the same product-related quality system,

(iv) the documentation on the quality system,

(v) an undertaking by the manufacturer to fulfil the obligations

imposed by the quality system approved,

(vi) an undertaking by the manufacturer to keep the approved quality

system adequate and efficacious,

(vii)

an undertaking by the manufacturer to institute and keep up to

date a systematic procedure to review experience gained from

devices in the post-production phase, including the provisions

referred to in Schedule X to these regulations, and to implement

appropriate means to apply any necessary corrective action. This

undertaking must include an obligation for the manufacturer to

notify the competent authorities of the following incidents

immediately on learning of them

1. any malfunction or deterioration in the characteristics and, or

performance of a device, as well as any inadequacy in the

instructions for use which might lead to or might have led to

the death of a patient or user or to a serious deterioration in

his state of health;

2. any technical or medical reason connected with the

characteristics or performance of a device leading for the

reasons referred to in the first paragraph above to systematic

recall of devices of the same type by the manufacturer.

(b) Application of the quality system must ensure that the products conform

to the provisions of these regulations which apply to them at every

stage, from design to final inspection. All the elements, requirements

and provisions adopted by the manufacturer for his quality system must

be documented in a systematic and orderly manner in the form of

written policies and procedures such as quality programmes, quality

plans, quality manuals and quality records.

It shall include in particular the corresponding documentation, data and

records arising from the procedures referred to in section 3(b)(iii).

It shall include in particular an adequate description of

(i) the manufacturer’s quality objectives;

(ii) the organisation of the business and in particular

1. the organisational structures, the responsibilities of the

managerial staff and their organisational authority where

quality of design and manufacture of the products is

concerned,

2. the methods of monitoring the efficient operation of the

quality system and in particular its ability to achieve the

desired quality of design and of product, including control of

products which fail to conform,

3. where the design, manufacture and, or final inspection and

testing of the products, or elements thereof, is carried out by a

third party, the methods of monitoring the efficient operation

of the quality system and in particular the type and extent of

control applied to the third party;

(iii) the procedures for monitoring and verifying the design of the

products, including the corresponding documentation, and in

particular

1. a general description of the product, including any variants

planned, and its intended use,

2. the design specifications, including the standards which will

be applied and the results of the risk analysis, and also a

description of the solutions adopted to fulfil the essential

requirements which apply to the products if the standards

referred to in regulation 5(6) are not applied in full,

3. the techniques used to control and verify the design and the

processes and systematic measures which will be used when

the products are being designed,

4. if the device is to be connected to any other device in order to

operate as intended, proof must be provided that it conforms

to the essential requirements when connected to any such

device having the characteristics specified by the

manufacturer,

5. a statement indicating whether or not the device incorporates,

as an integral part, a substance or a human blood derivative

referred to in section 7(d) of Schedule I and the data on the

tests conducted in this connection required to assess the

safety, quality and usefulness of that substance or human

blood derivative, taking account of the intended purpose of

the device,

6. a statement indicating whether or not the device is

manufactured utilising tissues of animal origin as referred to

in the definition of a “medical device manufactured utilising

tissues of animal origin” in regulation 3,

7. the solutions adopted as referred to in section 2 of Schedule I,

8. the pre-clinical evaluation,

9. the clinical evaluation referred to in Schedule X,

10. the draft label and, where appropriate, instructions for use.

(iv)

the inspection and quality assurance techniques at the

manufacturing stage and in particular

1. the process and procedures which will be used, particularly as

regards sterilisation, purchasing and the relevant documents,

2. the product identification procedures drawn up and kept up to

date from drawings, specifications or other relevant

documents at every stage of manufacture;

(v)

the appropriate tests and trials which will be carried out before,

during and after manufacture, the frequency with which they will

take place, and the test equipment used; it must be possible to

track back the calibration of the test equipment adequately.

(c) The notified body must audit the quality system to determine whether it

meets the requirements referred to in section 3(b). It must presume that

quality systems which implement the relevant harmonized standards

conform to these requirements.

(i)

The assessment team must include at least one member with past

experience of assessments of the technology concerned. The

assessment procedure must include an assessment, on a

representative basis, of the documentation of the design of any

product concerned, an inspection on the manufacturer's premises

and, in duly substantiated cases, on the premises of the

manufacturer's suppliers and, or subcontractors to inspect the

manufacturing processes.

(ii) The decision is notified to the manufacturer. It must contain the

conclusions of the inspection and a reasoned assessment.

(d) The manufacturer must inform the notified body which approved the

quality system of any plan for substantial changes to the quality system

or the product range covered. The notified body must assess the changes

proposed and verify whether after these changes the quality system still

meets the requirements referred to in section 3(b). It must notify the

manufacturer of its decision. This decision must contain the conclusions

of the inspection and a reasoned assessment.

(4)

Examination of the design of the product

(a) In addition to the obligations imposed by section 3, the manufacturer

must lodge with the notified body an application for examination of the

design dossier relating to the product which he plans to manufacture

and which falls into the category referred to in section 3(a).

(b) The application must describe the design, manufacture and

performances of the product in question. It must include the documents

needed to assess whether the product conforms to the requirements of

these regulations, as referred to in section 3(b)(iii).

(c) The notified body must examine the application and, if the product

conforms to the relevant provisions of these regulations, issue the

application with an EC design-examination certificate. The notified

body may require the application to be completed by further tests or

proof to allow assessment of conformity with the requirements of these

regulations. The certificate must contain the conclusions of the

examination, the conditions of validity, the data needed for

identification of the approved design, where appropriate, a description

of the intended purpose of the product.

(i)

In the case of devices referred to in section 7(d)(i) of Schedule I

to these regulations, the notified body shall, as regards the aspects

referred to in that section, consult one of the competent

authorities designated by the Member States in accordance with

Directive 2001/83/EC or the EMEA before taking a decision. The

opinion of the competent national authority or the EMEA must be

drawn up within 210 days after receipt of a valid documentation.

The scientific opinion of the competent national authority or the

EMEA must be included in the documentation concerning the

device. The notified body will give due consideration to the views

expressed in this consultation when making its decision. It will

convey its final decision to the competent body concerned.

(ii) In the case of devices referred to in section 7(d)(ii) of Schedule I,

the scientific opinion of the EMEA must be included in the

documentation concerning the device. The opinion of the EMEA

must be drawn up within 210 days after receipt of a valid

documentation. The notified body will give due consideration to

the opinion of the EMEA when making its decision. The notified

body may not deliver the certificate if the EMEA's scientific

opinion is unfavourable. It will convey its final decision to the

EMEA.

(iii) In the case of devices manufactured utilising tissues of animal

origin as referred to in the definition of a “medical device

manufactured utilising tissues of animal origin” in regulation 3,

the notified body must follow the procedures referred to in these

regulations.

(d) Changes to the approved design must receive further approval from the

notified body which issued the EC design-examination certificate

wherever the changes could affect conformity with the essential

requirements of these regulations or with the conditions prescribed for

use of the product. The applicant shall inform the notified body which

issued the EC design-examination certificate of any such changes made

to the approved design. This additional approval must take the form of a

supplement to the EC design-examination certificate.

(5)

Surveillance

(a) The aim of surveillance is to ensure that the manufacturer duly fulfils

the obligations imposed by the approved quality system.

(b) The manufacturer must authorise the notified body to carry out all the

necessary inspections and supply it with all relevant information, in

particular

(i) the documentation on the quality system,

(ii) the data stipulated in the part of the quality system relating to

design, such as the results of analyses, calculations, tests, the

solutions adopted as referred to in section 2 of Schedule I, pre-

clinical and clinical evaluation, post-market clinical follow-up

plan and the results of the post-market clinical follow-up, if

applicable, etc.,

(iii) the data stipulated in the part of the quality system relating to

manufacture, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc.

(c) The notified body must periodically carry out appropriate inspections

and assessments to make sure that the manufacturer applies the

approved quality system and must supply the manufacturer with an

assessment report.

(d) In addition, the notified body may pay unannounced visits to the

manufacturer.

At the time of such visits, the notified body may, where necessary, carry

out or ask for tests in order to check that the quality system is working

properly. It must provide the manufacturer with an inspection report

and, if a test has been carried out, with a test report.

(6)

Administrative provisions

(a) The manufacturer or his authorised representative must, for a period

ending at least five years, and in the case of implantable devices at least

15 years, after the last product has been manufactured, keep at the

disposal of the national authorities

(i) the declaration of conformity,

(ii) the documentation referred to in section 3(a)(iv) and in particular

the documentation, data and records referred to in section 3(b),

(iii) the changes referred to in section 3(d),

(iv) the documentation referred to in section 4(b), and

(v) the decisions and reports from the notified body as referred to in

sections 3(c), 4(c), 4(d), 5(c) and 5(d).

(7)

Application to devices in Classes IIa and IIb

(a) In line with regulations 6(2) and (3), this Schedule may apply to

products in Classes IIa and IIb. section 4, however, does not apply.

(b) For devices in Class IIa the notified body shall assess, as part of the

assessment in section 3(c), the technical documentation as described in

section 3(b)(iii) for at least one representative sample for each device

subcategory for compliance with the provisions of these regulations.

(c) For devices in Class IIb the notified body shall assess, as part of the

assessment in section 3(c), the technical documentation as described in

section 3(b)(iii) for at least one representative sample for each generic

device group for compliance with the provisions of these regulations.

(d) In choosing any representative sample the notified body shall take into

account the novelty of the technology, similarities in design,

technology, manufacturing and sterilisation methods, the intended use

and the results of any previous relevant assessments (e.g. with regard to

physical, chemical or biological properties) that have been carried out

in accordance with these regulations. The notified body shall document

and keep available to the Regulatory Affairs Directorate its rationale for

any sample taken.

(e) Further samples shall be assessed by the notified body as part of the

surveillance assessment referred to in section 5.

(8)

Application to the devices referred to in regulation 4(3)(b)

Upon completing the manufacture of each batch of devices referred to in

regulation 4(3)(b), the manufacturer shall inform the notified body of the release of

the batch of devices and send to it the official certificate concerning the release of

the batch of human blood derivative used in the device, issued by a State laboratory

or a laboratory designated for that purpose by a Member State in accordance with

article 104A(4) of the Medicines Act.

Schedule III

Based on Annex III of Directive 93/42/EEC

EC TYPE-EXAMINATION

(1) EC type-examination is the procedure whereby a notified body ascertains

and certifies that a representative sample of the production covered fulfils the

relevant provisions of these regulations.

(2)

The application includes

(a) the name and address of the manufacturer and the name and address of

the authorised representative if the application is lodged by the

representative,

(b) the documentation described in section 3 below needed to assess the

conformity of the representative sample of the production in question,

hereinafter referred to as the ‘type’, with the requirements of these

regulations. The applicant must make a ‘type’ available to the notified

body. The notified body may request other samples as necessary,

(c) a written declaration that no application has been lodged with any other

notified body for the same type.

(3) The documentation must allow an understanding of the design, the

manufacture and the performances of the product and must contain the following

items in particular

(a) a general description of the type, including any variants planned, and

any intended use,

(b) design drawings, methods of manufacture envisaged, in particular as

regards sterilisation, and diagrams of components, sub-assemblies,

circuits, etc.,

(c) the descriptions and explanations necessary to understand the

abovementioned drawings and diagrams and the operation of the

product,

(d) a list of the standards referred to in regulation 5(6), applied in full or in

part, and descriptions of the solutions adopted to meet the essential

requirements if the standards referred to regulation 5(6) have not been

applied in full,

(e) the results of the design calculations, risk analysis, investigations,

technical tests, etc., carried out,

(f)

a statement indicating whether or not the device incorporates, as an

integral part, a substance, or human blood derivative, referred to in

section 7(d) of Schedule I, and the data on the tests conducted in this

connection which are required to assess the safety, quality and

usefulness of that substance, or human blood derivative, taking account

of the intended purpose of the device,

(g) a statement indicating whether or not the device is manufactured

utilising tissues of animal origin as referred to in the definition for a

“medical device manufactured utilising tissues of animal origin” in

regulation 3,

(h) the solutions adopted as referred to in section 2 of Schedule I,

(i)

the pre-clinical evaluation,

(j)

the clinical evaluation referred to in Schedule X,

(k) the draft label and, where appropriate, instructions for use.

(4)

The notified body must

(a) examine and assess the documentation and verify that the type has been

manufactured in conformity with that documentation; it must also

record the items designed in conformity with the applicable provisions

of the standards referred to in regulation 5(6), as well as the items not

designed on the basis of the relevant provisions of the abovementioned

standards;

(b) carry out or arrange for the appropriate inspections and the tests

necessary to verify whether the solutions adopted by the manufacturer

meet the essential requirements of these regulations if the standards

referred to in regulation 5(6) have not been applied; if the device is to

be connected to any other device in order to operate as intended, proof

must be provided that it conforms to the essential requirements when

connected to any such device having the characteristics specified by the

manufacturer;

(c) carry out or arrange for the appropriate inspections and the tests

necessary to verify whether, if the manufacturer has chosen to apply the

relevant standards, these have actually been applied;

(d) agree with the applicant on the place where the necessary inspections

and tests will be carried out.

(5)

(a) If the type conforms to the provisions of these regulations, the notified

body issues the applicant with an EC type-examination certificate. The

certificate must contain the name and address of the manufacturer, the

conclusions of the inspection, the conditions of validity and the data

needed for identification of the type approved. The relevant parts of the

documentation must be annexed to the certificate and a copy kept by the

notified body.

(b) In the case of devices referred to in section 7(d)(i) of Schedule I, the

notified body shall, as regards the aspects referred to in that section,

consult one of the authorities designated by the Member States in

accordance with Directive 2001/83/EC or the EMEA before taking a

decision.

The opinion of the competent national authority or the EMEA must be

drawn up within 210 days after receipt of a valid documentation. The

scientific opinion of the competent national authority or the EMEA

must be included in the documentation concerning the device. The

notified body will give due consideration to the views expressed in this

consultation when making its decision. It will convey its final decision

to the competent body concerned.

(c) In the case of devices referred to in section 7(d)(ii) of Schedule I to

these regulations, the scientific opinion of the EMEA must be included

in the documentation concerning the device. The opinion of the EMEA

must be drawn up within 210 days after receipt of a valid

documentation. The notified body will give due consideration to the

opinion of the EMEA when making its decision.

The notified body may not deliver the certificate if the EMEA's

scientific opinion is unfavourable. It will convey its final decision to the

EMEA.

(d) In the case of devices manufactured utilising tissues of animal origin as

referred to in the definition of a “medical device manufactured utilising

tissues of animal origin” in regulation 3, the notified body must follow

the applicable procedures referred to in these regulations.

(6)

(a) The applicant must inform the notified body which issued the EC type-

examination certificate of any significant change made to the approved

product.

(b) Changes to the approved product must receive further approval from the

notified body which issued the EC type-examination certificate

wherever the changes may affect conformity with the essential

requirements or with the conditions prescribed for use of the product.

This new approval must, where appropriate, take the form of a

supplement to the initial EC type-examination certificate.

(7)

Administrative provisions

(a) Other notified bodies may obtain a copy of the EC type-examination

certificates and, or the supplements thereto. The Annexes to the

certificates must be made available to other notified bodies on reasoned

application, after the manufacturer has been informed.

(b) The manufacturer or his authorised representative must keep with the

technical documentation copies of EC type-examination certificates and

their additions for a period ending at least five years after the last device

has been manufactured. In the case of implantable devices, the period

shall be at least 15 years after the last product has been manufactured.

Schedule IV

Based on Annex IV of Directive 93/42/EEC

EC VERIFICATION

(1) EC verification is the procedure whereby the manufacturer or his authorised

representative ensures and declares that the products which have been subject to the

procedure set out in section 4 of this Schedule conform to the type described in the

EC type-examination certificate and meet the requirements of these regulations

which apply to them.

(2)

(a) The manufacturer must take all the measures necessary to ensure that

the manufacturing process produces products which conform to the type

described in the EC type-examination certificate and to the requirements

of the regulations which apply to them. Before the start of manufacture,

the manufacturer must prepare documents defining the manufacturing

process, in particular as regards sterilisation where necessary, together

with all the routine, pre-established provisions to be implemented to

ensure homogeneous production and, where appropriate, conformity of

the products with the type described in the EC type-examination

certificate and with the requirements of these regulations which apply to

them. The manufacturer must affix the CE marking in accordance with

regulations 5(3) to (5) and draw up a declaration of conformity.

(b) In addition, for products placed on the market in sterile condition, and

only for those aspects of the manufacturing process designed to secure

and maintain sterility, the manufacturer must apply the provisions of

sections 3 and 4 of Schedule V.

(3) The manufacturer must undertake to institute and keep up to date a

systematic procedure to review experience gained from devices in the post-

production phase, including the provisions referred to in Schedule X, and to

implement appropriate means to apply any necessary corrective action. This

undertaking must include an obligation for the manufacturer to notify the competent

authorities of the following incidents immediately on learning of them

(a) any malfunction or deterioration in the characteristics and, or

performance of a device, as well as any inadequacy in the labelling or

the instructions for use which might lead to or might have led to the

death of a patient or user or to a serious deterioration in his state of

health;

(b) any technical or medical reason connected with the characteristics or

performance of a device for the reasons referred to in section 3(a)

leading to systematic recall of devices of the same type by the

manufacturer.

(4) The notified body must carry out the appropriate examinations and tests in

order to verify the conformity of the product with the requirements of the regulations

either by examining and testing every product as specified in section 5 or by

examining and testing products on a statistical basis as specified in section 6, as the

m a n u f a c t u r e r d e c i d e s . T h e s e c h e c k s d o n o t a p p l y t o t h o s e a s p e c ts o f t h e

manufacturing process designed to secure sterility.

(5)

Verification by examination and testing of every product

(a) Every product is examined individually and the appropriate tests

defined in any relevant standard referred to in regulation 5(6) or

equivalent tests must be carried out in order to verify, where

appropriate, the conformity of the products with the EC type described

in the type-examination certificate and with the requirements of the

regulations which apply to them.

(b) The notified body must affix, or have affixed its identification number

to each approved product and must draw up a written certificate of

conformity relating to the tests carried out.

(6)

Statistical verification

(a) The manufacturer must present the manufactured products in the form

of homogeneous batches.

(b) A random sample is taken from each batch. The products which make

up the sample are examined individually and the appropriate tests

defined in any relevant standard referred to in regulation 5(6) or

equivalent tests must be carried out to verify, where appropriate, the

conformity of the products with the type described in the EC type-

examination certificate and with the requirements of the regulation

which apply to them in order to determine whether to accept or reject

the batch.

(c) Statistical control of products will be based on attributes and, or

variables, entailing sampling schemes with operational characteristics

which ensure a high level of safety and performance according to the

state of the art. The sampling schemes will be established by the

harmonised standards referred to in regulation 5(6), taking account of

the specific nature of the product categories in question.

(d) If the batch is accepted, the notified body affixes or has affixed its

identification number to each product and draws up a written certificate

of conformity relating to the tests carried out. All products in the batch

may be put on the market except any in the sample which failed to

conform.

(i)

If a batch is rejected, the competent notified body must take

appropriate measures to prevent the batch from being placed on

the market. In the event of frequent rejection of batches, the

notified body may suspend the statistical verification.

(ii) The manufacturer may, on the responsibility of the notified body,

affix the notified body's identification number during the

manufacturing process.

(7)

Administrative provisions

(a) The manufacturer or his authorised representative must, for a period

ending at least five years, and in the case of implantable devices at least

15 years, after the last product has been manufactured, make available

to the national authorities

(i) the declaration of conformity,

(ii) the documentation referred to in section 2,

(iii) the certificates referred to in sections 5(b) and 6(d),

(iv) where appropriate, the type-examination certificate referred to in

Schedule III.

(8)

Application to devices in Class IIa

In line with regulation 6(2), this Schedule may apply to products in Class

IIa, subject to the following

(a) in derogation from sections 1 and 2, by virtue of the declaration of

conformity the manufacturer ensures and declares that the products in

Class IIa are manufactured in conformity with the technical

documentation referred to in section 3 of Schedule VII and meet the

requirements of these regulations which apply to them;

(b) in derogation from sections 1, 2, 5 and 6, the verifications conducted by

the notified body are intended to confirm the conformity of the products

in Class IIa with the technical documentation referred to in section 3 of

Schedule VII.

(9)

Application to devices referred to in regulation 4(3)(b)

In the case of section 5, upon completing the manufacture of each batch of

devices referred to in the proviso to regulation 4(3)(b), and in the case of verification

under section 6, the manufacturer shall inform the notified body of the release of this

batch of devices and send to it the official certificate concerning the release of the

batch of human blood derivative used in the device issued by a State laboratory or a

laboratory designated for that purpose by a Member State in accordance with article

104A(4) of the Medicines Act.

Schedule V

Based on Annex V of Directive 93/42/EEC

EC DECLARATION OF CONFORMITY (Production quality assurance)

(1) The manufacturer must ensure application of the quality system approved

for the manufacture of the products concerned and carry out the final inspection, as

specified in section 3, and is subject to the Maltese or Community surveillance

referred to in section 4.

(2)

(a) The EC declaration of conformity is the part of the procedure whereby

the manufacturer who fulfils the obligations imposed by section 1

ensures and declares that the products concerned conform to the type

described in the EC type-examination certificate and meet the

provisions of these regulations which apply to them.

(b) The manufacturer must affix the CE marking in accordance with

regulations 5(3) to (5) and draw up a written declaration of conformity.

This declaration must cover one or more medical devices manufactured,

clearly identified by means of product name, product code or other

unambiguous reference, and must be kept by the manufacturer.

(3)

Quality system

(a) The manufacturer must lodge an application for assessment of his

quality system with a notified body.

The application must include

(i) the name and address of the manufacturer,

(ii) all the relevant information on the product or product category

covered by the procedure,

(iii) a written declaration that no application has been lodged with any

other notified body for the same products,

(iv) the documentation on the quality system,

(v) an undertaking to fulfil the obligations imposed by the quality

system is approved,

(vi) an undertaking to maintain the practicability and effectiveness of

the approved quality system,

(vii)

where appropriate, the technical documentation on the types

approved and a copy of the EC type-examination certificates,

(viii) an undertaking by the manufacturer to institute and keep up to

date a systematic procedure to review experience gained from

devices in the post-production phase, including the provisions

referred to in Schedule X, and to implement appropriate means to

apply any necessary corrective action. This undertaking must

include an obligation for the manufacturer to notify the

Regulatory Affairs Directorate of the following incidents

immediately on learning of them

1. any malfunction or deterioration in the characteristics and, or

performance of a device, as well as any inadequacy in the

labelling or the instructions for use which might lead to or

might have led to the death of a patient or user or to a serious

deterioration in his state of health;

2. any technical or medical reason connected with the

characteristics or performance of a device for the reasons

referred to in the first indent above leading to a systematic

recall of devices of the same type by the manufacturer.

(b) Application of the quality system must ensure that the products conform

to the type described in the EC type-examination certificate.

All the elements, requirements and provisions adopted by the

manufacturer for his quality system must be documented in a systematic

and orderly manner in the form of written policy statements and

procedures. This quality system documentation must permit uniform

interpretation of the quality policy and procedures such as quality

programmes, plans, manuals and records.

It must include in particular an adequate description of

(i) the manufacturer’s quality objectives;

(ii) the organisation of the business and in particular

1. the organisational structures, the responsibilities of the

managerial staff and their organisational authority where

manufacture of the products is concerned,

2. the methods of monitoring the efficient operation of the

quality system and in particular its ability to achieve the

desired quality of product, including control of products

which fail to conform,

3. where the manufacture and, or final inspection and testing of

the products, or elements thereof, are carried out by a third

party, the methods of monitoring the efficient operation of the

quality system and in particular the type and extent of control

applied to the third party;

(iii) the inspection and quality assurance techniques at the

manufacturing stage and in particular

1. the processes and procedures which will be used, particularly

as regards sterilisation, purchasing and the relevant

documents,

2. the product identification procedures drawn up and kept up to

date from drawings, specifications or other relevant

documents at every stage of manufacture;

(iv)

the appropriate tests and trials to be carried out before, during and

after manufacture, the frequency with which they will take place,

and the test equipment used; it must be possible adequately to

trace back the calibration of the test equipment.

(c) The notified body must audit the quality system to determine whether it

meets the requirements referred to in section 3(b). It must presume that

quality systems which implement the relevant harmonized standards

conform to these requirements.

The assessment team must include at least one member with past

experience of assessments of the technology concerned. The assessment

procedure must include an inspection on the manufacturer's premises

and, in duly substantiated cases, on the premises of the manufacturer's

suppliers to inspect the manufacturing processes.

The decision must be notified to the manufacturer after the final

inspection and contain the conclusions of the inspection and a reasoned

assessment.

(d) The manufacturer must inform the notified body which approved the

quality system of any plan for substantial changes to the quality system.

The notified body must assess the changes proposed and verify whether

after these changes the quality system still meets the requirements

referred to in section 3(b).

After the abovementioned information has been received the decision is

notified to the manufacturer. It must contain the conclusions of the

inspection and a reasoned assessment.

(4)

Surveillance

(a) The aim of surveillance is to ensure that the manufacturer duly fulfils

the obligations imposed by the approved quality system.

(b) The manufacturer authorises the notified body to carry out all the

necessary inspections and must supply it with all relevant information,

in particular

(i) the documentation on the quality system,

(ii) the technical documentation,

(iii) the data stipulated in the part of the quality system relating to

manufacture, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc.

(c) The notified body must periodically carry out appropriate inspections

and assessments to make sure that the manufacturer applies the

approved quality system and supply the manufacturer with an

assessment report.

(d) In addition, the notified body may pay unannounced visits to the

manufacturer. At the time of such visits, the notified body may, where

necessary, carry out or ask for tests in order to check that the quality

system is working properly. It must provide the manufacturer with an

inspection report and, if a test has been carried out, with a test report.

(5)

Administrative provisions

(a) The manufacturer or his authorised representative must, for a period

ending at least five years, and in the case of implantable devices at least

15 years, after the last product has been manufactured, make available

to the Market Surveillance Directorate and the Regulatory Affairs

Directorate

(i)

the declaration of conformity,

(ii)

the documentation referred to in section 3(a)(iv),

(iii)

the changes referred to in section 3(d),

(iv)

the documentation referred to in section 3(a)(vii),

(v)

the decisions and reports from the notified body as referred to in

sections 4(c) and 4(d),

(vi)

where appropriate, the type-examination certificate referred to in

Schedule III.

(6)

Application to devices in Class IIa

In line with regulation 6(2), this Schedule may apply to products in Class

IIa, subject to the following

(a) By way of derogation from sections 2, 3(a) and 3(b), by virtue of the

declaration of conformity the manufacturer ensures and declares that

the products in Class IIa are manufactured in conformity with the

technical documentation referred to in section 3 of Schedule VII and

meet the requirements of these regulations which apply to them.

(b) For devices in Class IIa the notified body shall assess, as part of the

assessment in section 3(c), the technical documentation as described in

section 3 of Schedule VII for at least one representative sample for each

device subcategory for compliance with the provisions of these

regulations.

(c) In choosing any representative sample the notified body shall take into

account the novelty of the technology, similarities in design,

technology, manufacturing and sterilisation methods, the intended use

and the results of any previous relevant assessments (e.g. with regard to

physical, chemical or biological properties) that have been carried out

in accordance with these regulations. The notified body shall document

and keep available to the Regulatory Affairs Directorate its rationale for

any sample taken.

(d) Further samples shall be assessed by the notified body as part of the

surveillance assessment referred to in section 4(c).

(7)

Application to devices referred to regulation 4(3)(b)

Upon completing the manufacture of each batch of devices referred to in

regulation 4(3)(b), the manufacturer shall inform the notified body of the release of

the batch of devices and send to it the official certificate concerning the release of

the batch of human blood derivative used in the device issued by a State laboratory

or a laboratory designated for that purpose by a Member State in accordance with

article 104A(4) of the Medicines Act.

Schedule VI

Based on Annex VI of Directive 93/42/EEC

EC DECLARATION OF CONFORMITY (Product quality assurance)

(1) The manufacturer must ensure application of the quality system approved

for the final inspection and testing of the product, as specified in section 3 and must

be subject to the surveillance referred to in section 4.

In addition, for products placed on the market in sterile condition, and only

for those aspects of the manufacturing process designed to secure and maintain

sterility, the manufacturer must apply the provisions in sections 3 and 4 of Schedule

V.

(2) The EC declaration of conformity is the part of the procedure whereby the

manufacturer who fulfils the obligations imposed by section 1 above ensures and

declares that the products concerned conform to the type described in the EC type-

examination certificate and meet the provisions of these regulations which apply to

them.

The manufacturer affixes the CE marking in accordance with regulations

5(3) to (5) and draws up a written declaration of conformity. This declaration must

cover one or more medical devices manufactured, clearly identified by means of

product name, product code or other unambiguous reference, and be kept by the

manufacturer. The CE marking must be accompanied by the identification number of

the notified body which performs the tasks referred to in this Schedule.

(3)

Quality System

(a) The manufacturer lodges an application for assessment of his quality

system with a notified body.

The application must include

(i) the name and address of the manufacturer,

(ii) all the relevant information on the product or product category

covered by the procedure,

(iii) a written declaration that no application has been lodged with any

other notified body for the same products,

(iv) the documentation on the quality system,

(v) an undertaking to fulfil the obligations imposed by the quality

system is approved,

(vi) an undertaking by the manufacturer to keep the approved quality

system adequate and efficacious,

(vii)

where appropriate, the technical documentation on the types

approved and a copy of the EC type-examination certificates,

(viii) an undertaking by the manufacturer to institute and keep up to

date a systematic procedure to review experience gained from

devices in the post-production phase, including the provisions

referred to in Schedule X, and to implement appropriate means to

apply any necessary corrective action. This undertaking must

include an obligation for the manufacturer to notify the

Regulatory Affairs Directorate of the following incidents

immediately on learning of them

1. any malfunction or deterioration in the characteristics and, or

performance of a device, as well as any inadequacy in the

labelling or the instructions for use which might lead to or

might have led to the death of a patient or user or to a serious

deterioration in his state of health;

2. any technical or medical reason connected with the

characteristics or performance of a device for the reasons

referred to in the first indent above leading to a systematic

recall of devices of the same type by the manufacturer.

(b) Under the quality system, each product or a representative sample of

each batch is examined and the appropriate tests defined in any relevant

standard referred to in regulation 5(6) or equivalent tests are carried out

to ensure that the products conform to the type described in the EC

type-examination certificate and fulfil the provisions of these

regulations which apply to them. All the elements, requirements and

provisions adopted by the manufacturer must be documented in a

systematic and orderly manner in the form of written measures,

procedures and instructions. This quality system documentation must

permit uniform interpretation of the quality programmes, quality plans,

quality manuals and quality records.

It must include in particular an adequate description of

(i)

the quality objectives and the organisational structure,

responsibilities and powers of the managerial staff with regard to

product quality,

(ii) the examinations and tests that will be carried out after

manufacture; it must be possible to trace back the calibration of

the test equipment adequately,

(iii) the methods of monitoring the efficient operation of the quality

system,

(iv) the quality records, such as reports concerning inspections, tests,

calibration and the qualifications of the staff concerned, etc.,

(v) where the final inspection and testing of the products, or elements

thereof, are carried out by a third party, the methods of

monitoring the efficient operation of the quality system and in

particular the type and extent of control applied to the third party;

The aforementioned checks do not apply to those aspects of the

manufacturing process designed to secure sterility.

(c) The notified body audits the quality system to determine whether it

meets the requirements referred to in section 3(b). It must presume that

quality systems which implement the relevant harmonised standards

conform to these requirements.

The assessment team must include at least one member with past

experience of assessments of the technology concerned. The assessment

procedure must include an inspection on the manufacturer's premises

and, in duly substantiated cases, on the premises of the manufacturer's

suppliers to inspect the manufacturing processes.

The decision must be notified to the manufacturer. It must contain the

conclusions of the inspection and a reasoned assessment.

(d) The manufacturer must inform the notified body which approved the

quality system of any plan for substantial changes to the quality system.

The notified body must assess the changes proposed and verify whether

after these changes the quality system will still meet the requirements

referred to in section 3(b).

After receiving the abovementioned information it must notify the

manufacturer of its decision. This decision must contain the conclusions

of the inspection and a reasoned assessment.

(4)

Surveillance

(a) The aim of surveillance is to ensure that the manufacturer duly fulfils

the obligations imposed by the approved quality system.

(b) The manufacturer must allow the notified body access for inspection

purposes to the inspection, testing and storage locations and supply it

with all relevant information, in particular

(i) the documentation on the quality system,

(ii) the technical documentation,

(iii) the quality records, such as inspection reports, test data,

calibration data, qualification reports of the staff concerned, etc.

(c) The notified body must periodically carry out appropriate inspections

and assessments to make sure that the manufacturer applies the

approved quality system and must supply the manufacturer with an

assessment report.

(d) In addition, the notified body may pay unannounced visits to the

manufacturer.

At the time of such visits, the notified body may, where necessary, carry

out or ask for tests in order to check that the quality system is working

properly and that the production conforms to the requirements of these

regulations which apply to it. To this end, an adequate sample of the

final products, taken on site by the notified body, must be examined and

the appropriate tests defined in any relevant standard referred to in

regulation 5(6) or equivalent tests must be carried out. Where one or

more of the samples fails to conform, the notified body must take the

appropriate measures.

It must provide the manufacturer with an inspection report and, if a test

has been carried out, with a test report.

(5)

Administrative provisions

(a) The manufacturer or his authorised representative must, for a period

ending at least five years, and in the case of implantable devices at least

15 years, after the last product has been manufactured, make available

to the Market Surveillance Directorate and the Regulatory Affairs

Directorate

(i)

the declaration of conformity,

(ii)

the documentation referred to in section 3(a)(vii),

(iii)

the changes referred to in section 3(d),

(iv)

the decisions and reports from the notified body as referred to in

sections 3(d), 4(c) and 4(d),

(v)

where appropriate, the certificate of conformity referred to in

Schedule III.

(6)

Application to devices in Class IIa

In line with regulation 6(2), this Schedule may apply to products in Class

IIa, subject to the following

(a) By way of derogation from sections 2, 3(a) and 3(b), by virtue of the

declaration of conformity the manufacturer ensures and declares that

the products in Class IIa are manufactured in conformity with the

technical documentation referred to in section 3 of Schedule VII and

meet the requirements of these regulations which apply to them.

(b) For devices in Class IIa the notified body shall assess, as part of the

assessment in section 3(c) above, the technical documentation as

described in section 3 of Schedule VII for at least one representative

sample for each device subcategory for compliance with the provisions

of these regulations.

(c) In choosing any representative sample the notified body shall take into

account the novelty of the technology, similarities in design,

technology, manufacturing and sterilisation methods, the intended use

and the results of any previous relevant assessments (e.g. with regard to

physical, chemical or biological properties) that have been carried out

in accordance with these regulations. The notified body shall document

and keep available to the Regulatory Affairs Directorate its rationale for

any sample taken.

(d) Further samples shall be assessed by the notified body as part of the

surveillance assessment referred to in section 4(c).

Schedule VII

Based on Annex VII of Directive 93/42/EEC

EC DECLARATION OF CONFORMITY

(1) The EC declaration of conformity is the procedure whereby the

manufacturer or his authorised representative who fulfils the obligations imposed by

section 2 and, in the case of products placed on the market in a sterile condition and

devices with a measuring function, the obligations imposed by section 5 ensures and

declares that the products concerned meet the provisions of these regulations which

apply to them.

(2) The manufacturer must prepare the technical documentation described in

section 3 . The manufacturer or his authorised representative must make this

documentation, including the declaration of conformity, available to the Market

Surveillance Directorate for inspection purposes for a period ending at least five

years after the last product has been manufactured. In the case of implantable

devices the period shall be at least 15 years after the last product has been

manufactured.

(3) The technical documentation must allow assessment of the conformity of the

product with the requirements of these regulations. It must include in particular

(a) a general description of the product, including any variants planned and

its intended use,

(b) design drawings, methods of manufacture envisaged and diagrams of

components, sub-assemblies, circuits, etc.,

(c) the descriptions and explanations necessary to understand the

abovementioned drawings and diagrams and the operations of the

product,

(d) the results of the risk analysis and a list of the standards referred to in

regulation 5(6), applied in full or in part, and descriptions of the

solutions adopted to meet the essential requirements of the regulations

if the standards referred to in regulation 5(6) have not been applied in

full,

(e) in the case of products placed on the market in a sterile condition,

description of the methods used and the validation report,

(f)

the results of the design calculations and of the inspections carried out,

etc.; if the device is to be connected to any other device in order to

operate as intended, proof must be provided that it conforms to the

essential requirements when connected to any such device having the

characteristics specified by the manufacturer,

(g) the solutions adopted as referred to in section 2 of Schedule I,

(h) the pre-clinical evaluation,

(i)

the clinical evaluation in accordance with Schedule X to these

regulations,

(j)

the label and instructions for use.

(4) The manufacturer shall institute and keep up to date a systematic procedure

to review experience gained from devices in the post-production phase, including

the provisions referred to in Schedule X, and to implement appropriate means to

apply any necessary corrective actions, taking account of the nature and risks in

relation to the product. He shall notify the Regulatory Affairs Directorate of the

following incidents immediately on learning of them

(a) any malfunction or deterioration in the characteristics and, or

performance of a device, as well as any inadequacy in the labelling or

the instructions for use which might lead to or might have led to the

death of a patient or user or to a serious deterioration in his state of

health;

(b) any technical or medical reason connected with the characteristics on

the performance of a device for the reasons referred to in paragraph (a)

leading to systematic recall of devices of the same type by the

manufacturer.

(5) With products placed on the market in sterile condition and Class I devices

with a measuring function, the manufacturer must observe not only the provisions

laid down in this Schedule but also one of the procedures referred to in Schedule II,

IV, V or VI. Application of the abovementioned Schedules and the intervention by

the notified body is limited to

(a) in the case of products placed on the market in sterile condition, only

the aspects of manufacture concerned with securing and maintaining

sterile conditions,

(b) in the case of devices with a measuring function, only the aspects of

manufacture concerned with the conformity of the products with the

metrological requirements.

Section 6(a) is applicable.

(6)

Application to devices in Class IIa

In line with regulation 6(2), this Schedule may apply to products in Class

IIa, subject to the following derogation

(a) where this Schedule is applied in conjunction with the procedure

referred to in Schedules IV, V or VI, the declaration of conformity

referred to in the abovementioned Schedules forms a single declaration.

As regards the declaration based on this Schedule, the manufacturer

must ensure and declare that the product design meets the provisions of

these regulations which apply to it.

Schedule VIII

Based on Annex VIII of Directive 93/42/EEC

STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES

(1) For custom-made devices or for devices intended for clinical investigations

the manufacturer or his authorised representative must draw up the statement

containing the information stipulated in section 2.

(2)

The statement must contain the following information

(a) for custom-made devices

(i) the name and address of the manufacturer,

(ii) data allowing the identification of the device in question,

(iii) a statement that the device is intended for exclusive use by a

particular patient, together with the name of the patient,

(iv) the name of the medical practitioner or other authorised person

who made out the prescription and, where applicable, the name of

the clinic concerned,

(v) the specific characteristics of the product as indicated by the

prescription,

(vi) a statement that the device in question conforms to the essential

requirements set out in Schedule I and, where applicable,

indicating which essential requirements have not been fully met,

together with the grounds;

(b) for devices intended for the clinical investigations covered by Schedule

(i)

data allowing identification of the device in question,

(ii)

the clinical investigation plan,

(iii)

the investigator’s brochure,

(iv)

the confirmation of insurance of subjects,

(v)

the documents used to obtain informed consent,

(vi)

a statement indicating whether or not the device incorporates, as

an integral part, a substance or human blood derivative referred to

in section 7(d) of Schedule I,

(vii)

a statement indicating whether or not the device is manufactured

utilising tissues of animal origin as referred to in the definition of

“medical device manufactured utilising tissues of animal origin”

in article 3,

(viii) the opinion of the Ethics Committee concerned and details of the

aspects covered by its opinion,

(ix) the name of the medical practitioner or other authorised person

and of the institution responsible for the investigations,

(x) the place, starting date and scheduled duration for the

investigations,

(xi)

a statement that the device in question conforms to the essential

requirements apart from the aspects covered by the investigations

and that, with regard to these aspects, every precaution has been

taken to protect the health and safety of the patient.

(3) The manufacturer must also undertake to keep available for the Regulatory

Affairs Directorate and the Market Surveillance Directorate

(a) for custom-made devices, documentation, indicating manufacturing

sites and allowing an understanding of the design, manufacture and

performances of the product, including the expected performances, so

as to allow assessment of conformity with the requirements of these

regulations,

(b) for devices intended for clinical investigations, the documentation must

contain

(i) a general description of the product and its intended use,

(ii) design drawings, methods of manufacture envisaged, in particular

as regards sterilisation, and diagrams of components, sub-

assemblies, circuits, etc.,

(iii) the descriptions and explanations necessary to understand the

abovementioned drawings and diagrams and the operation of the

product,

(iv) the results of the risk analysis and a list of the standards referred

to in regulation 5(6), applied in full or in part, and descriptions of

the solutions adopted to meet the essential requirements of these

regulations if the standards referred to in regulation 5(6) have not

been applied,

(v) if the device incorporates, as an integral part, a substance or

human blood derivative referred to in section 7(d) of Schedule I,

the data on the tests conducted in this connection which are

required to assess the safety, quality and usefulness of that

substance or human blood derivative, taking account of the

intended purpose of the device,

(vi) if the device is manufactured utilising tissues of animal origin as

referred to in the definition of “medical device manufactured

utilising tissues of animal origin” in article 3, the risk

management measures in this connection which have been applied

to reduce the risk of infection,

(vii)

the results of the design calculations, and of the inspections and

technical tests carried out, etc.

The manufacturer must take all the measures necessary to ensure that

the manufacturing process produces products which are manufactured

in accordance with the documentation referred to in the first paragraph

of this section.

The manufacturer must authorise the assessment, or audit where

necessary, of the effectiveness of these measures.

(4) The information contained in the declarations concerned by this Schedule

shall be kept for a period of time of at least five years. In the case of implantable

devices the period shall be at least 15 years.

(5)

For custom-made devices, the manufacturer must undertake to review and

document experience gained in the post-production phase, including the provisions

referred to in Schedule X, and to implement appropriate means to apply any

necessary corrective action. This undertaking must include an obligation for the

manufacturer to notify the Regulatory Affairs Directorate of the following incidents

immediately on learning of them and the relevant corrective actions

(a) any malfunction or deterioration in the characteristics and, or

performance of a device, as well as any inadequacy in the labelling or

the instructions for use which might lead to or might have led to the

death of a patient or user or to a serious deterioration in his state of

health;

(b) any technical or medical reason connected with the characteristics or

performance of a device for the reasons referred to in section 5(a)

leading to systematic recall of devices of the same type by the

manufacturer.

Schedule IX

Based on Annex IX of Directive 93/42/EEC

CLASSIFICATION CRITERIA

(1)

Definitions for the classification rules

(a) Duration

(i)

Transient - Normally intended for continuous use for less than 60

minutes.

(ii) Short term - Normally intended for continuous use for not more

than 30 days.

(iii) Long term - Normally intended for continuous use for more than

30 days.

(b) Invasive devices

(i)

Invasive device - A device which, in whole or in part, penetrates

inside the body, either through a body orifice or through the

surface of the body.

(ii) Body orifice - Any natural opening in the body, as well as the

external surface of the eyeball, or any permanent artificial

opening, such as a stoma.

(iii) Surgically invasive device - An invasive device which penetrates

inside the body through the surface of the body, with the aid or in

the context of a surgical operation.

For the purposes of these regulations devices other than those

referred to in the previous sub-regulation and which product

penetration other than through an established body orifice, shall

be treated as surgically invasive devices.

(iv) Implantable device - Any device which is intended

1. to be totally introduced into the human body or,

2. to replace an epithelial surface or the surface of the eye,

by surgical intervention which is intended to remain in place after

the procedure.

Any device intended to be partially introduced into the human

body through surgical intervention and intended to remain in

place after the procedure for at least 30 days is also considered an

implantable device.

(c) Reusable surgical instrument

Instrument intended for surgical use by cutting, drilling, sawing,

scratching, scraping, clamping, retracting, clipping or similar

procedures, without connection to any active medical device and which

can be reused after appropriate procedures have been carried out.

(d) Active medical device

Any medical device operation of which depends on a source of

electrical energy or any source of power other than that directly

generated by the human body or gravity and which acts by converting

this energy. Medical devices intended to transmit energy, substances or

other elements between an active medical device and the patient,

without any significant change, are not considered to be active medical

devices.

Stand alone software is considered to be an active medical device.

(e) Active therapeutical device

Any active medical device, whether used alone or in combination with

other medical devices, to support, modify, replace or restore biological

functions or structures with a view to treatment or alleviation of an

illness, injury or handicap.

(f)

Active device for diagnosis

Any active medical device, whether used alone or in combination with

other medical devices, to supply information for detecting, diagnosing,

monitoring or treating physiological conditions, states of health,

illnesses or congenital deformities.

(g) Central circulatory system

For the purposes of these regulations, ‘central circulatory system’

means the following vessels

arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to

the bifurcatio aortae, arteriae coronariae, arteria carotis communis,

arteria carotis externa, arteria carotis interna, arteriae cerebrales,

truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava

superior, vena cava inferior.

(h) Central nervous system

For the purposes of these regulations, ‘central nervous system’ means

brain, meninges and spinal cord.

(2)

Implementing rules

(a) Application of the classification rules shall be governed by the intended

purpose of the devices.

(b) If the device is intended to be used in combination with another device,

the classification rules shall apply separately to each of the devices.

Accessories are classified in their own right separately from the device

with which they are used.

(c) Software, which drives a device or influences the use of a device, falls

automatically in the same class.

(d) If the device is not intended to be used solely or principally in a specific

part of the body, it must be considered and classified on the basis of the

most critical specified use.

(e) If several rules apply to the same device, based on the performance

specified for the device by the manufacturer, the strictest rules resulting

in the higher classification shall apply.

(f)

In calculating the duration referred to in section 1(a), continuous use

means an uninterrupted actual use of the device for the intended

purpose. However where usage of a device is discontinued in order for

the device to be replaced immediately by the same or an identical

device this shall be considered an extension of the continuous use of the

device.

(3)

Classification rules for non-invasive devices

(a) Rule 1

All non-invasive devices are in Class I, unless one of the rules set out

hereinafter applies.

(b) Rule 2

All non-invasive devices intended for channelling or storing blood,

body liquids or tissues, liquids or gases for the purpose of eventual

infusion, administration or introduction into the body are in Class IIa

(i)

if they may be connected to an active medical device in Class IIa

or a higher class,

(ii) if they are intended for use for storing or channelling blood or

other body liquids or for storing organs, parts of organs or body

tissues,

in all other cases they are in Class I.

(c) Rule 3

All non-invasive devices intended for modifying the biological or

chemical composition of blood, other body liquids or other liquids

intended for infusion into the body are in Class IIb, unless the treatment

consists of filtration, centrifugation or exchanges of gas, heat, in which

case they are in Class IIa.

(d) Rule 4

All non-invasive devices which come into contact with injured skin

(i)

are in Class I if they are intended to be used as a mechanical

barrier, for compression or for absorption of exudates,

(ii) are in Class IIb if they are intended to be used principally with

wounds which have breached the dermis and can only heal by

secondary intent,

(iii) are in Class IIa in all other cases, including devices principally

intended to manage the micro-environment of a wound.

(4)

Classification rules for invasive devices

(a) Rule 5

All invasive devices with respect to body orifices, other than surgically

invasive devices and which are not intended for connection to an active

medical device or which are intended for connection to an active

medical device in Class I

(i) are in Class I if they are intended for transient use,

(ii) are in Class IIa if they are intended for short-term use, except if

they are used in the oral cavity as far as the pharynx, in an ear

canal up to the ear drum or in a nasal cavity, in which case they

are in Class I,

(iii) are in Class IIb if they are intended for long-term use, except if

they are used in the oral cavity as far as the pharynx, in an ear

canal up to the ear drum or in a nasal cavity and are not liable to

be absorbed by the mucous membrane, in which case they are in

Class IIa.

All invasive devices with respect to body orifices, other than surgically

invasive devices, intended for connection to an active medical device in

Class IIa or a higher class, are in Class IIa.

(b) Rule 6

All surgically invasive devices intended for transient use are in Class IIa

unless they are

(i)

intended specifically to control, diagnose, monitor or correct a

defect of the heart or of the central circulatory system through

direct contact with these parts of the body, in which case they are

in Class III,

(ii) reusable surgical instruments, in which case they are in Class I,

(iii) intended specifically for use in direct contact with the central

nervous system, in which case they are in Class III,

(iv) intended to supply energy in the form of ionising radiation in

which case they are in Class IIb,

(v) intended to have a biological effect or to be wholly or mainly

absorbed in which case they are in Class IIb,

(vi) intended to administer medicines by means of a delivery system,

if this is done in a manner that is potentially hazardous taking

account of the mode of application, in which case they are in

Class IIb.

(c) Rule 7

All surgically invasive devices intended for short-term use are in Class

IIa unless they are intended to

(i)

either specifically to control, diagnose, monitor or correct a defect

of the heart or of the central circulatory system through direct

contact with these parts of the body, in which case they are in

Class III,

(ii) or specifically for use in direct contact with the central nervous

system, in which case they are in Class III,

(iii) or to supply energy in the form of ionising radiation in which case

they are in Class IIb,

(iv) or to have a biological effect or to be wholly or mainly absorbed

in which case they are in Class III,

(v) or to undergo chemical change in the body, except if the devices

are placed in the teeth, or to administer medicines, in which case

they are in Class IIb.

(d) Rule 8

All implantable devices and long-term surgically invasive devices are in

Class IIb unless they are intended

(i) to be placed in the teeth, in which case they are in Class IIa,

(ii) to be used in direct contact with the heart, the central circulatory

system or the central nervous system, in which case they are in

Class III,

(iii) to have a biological effect or to be wholly or mainly absorbed, in

which case they are in Class III,

(iv) or to undergo chemical change in the body, except if the devices

are placed in the teeth, or to administer medicines, in which case

they are in Class III.

(5)

Additional rules applicable to active devices

(a) Rule 9

All active therapeutic devices intended to administer or exchange

energy are in Class IIa unless their characteristics are such that they

may administer or exchange energy to or from the human body in a

potentially hazardous way, taking account of the nature, the density and

site of application of the energy, in which case they are in Class IIb.

All active devices intended to control or monitor the performance of

active therapeutic devices in Class IIb, or intended directly to influence

the performance of such devices are in Class IIb.

(b) Rule 10

Active devices intended for diagnosis are in Class IIa

(i)

if they are intended to supply energy which will be absorbed by

the human body, except for devices used to illuminate the

patient’s body, in the visible spectrum,

(ii) if they are intended to image in vivo distribution of

radiopharmaceuticals,

(iii) if they are intended to allow direct diagnosis or monitoring of vital

physiological processes, unless they are specifically intended for

monitoring of vital physiological parameters, where the nature of

variations is such that it could result in immediate danger to the

patient, for instance variations in cardiac performance,

respiration, activity of CNS in which case they are in Class IIb.

Active devices intended to emit ionizing radiation and intended for

diagnostic and therapeutic interventional radiology including devices

which control or monitor such devices, or which directly influence their

performance, are in Class IIb.

(c) Rule 11

All active devices intended to administer and, or remove medicines,

body liquids or other substances to or from the body are in Class IIa,

unless this is done in a manner

(i)

that is potentially hazardous, taking account of the nature of the

substances involved, of the part of the body concerned and of the

mode of application in which case they are in Class IIb.

(d) Rule 12

All other active devices are in Class I.

(6)

Special Rules

(a) Rule 13

All devices incorporating, as an integral part, a substance which, if used

separately, can be considered to be a medicinal product, as defined in

article 2 of the Medicines Act, and which is liable to act on the human

body with action ancillary to that of the devices, are in Class III.

All devices incorporating, as an integral part, a human blood derivative

are in Class III.

(b) Rule 14

All devices used for contraception or the prevention of the transmission

of sexually transmitted diseases are in Class IIb, unless they are

implantable or long term invasive devices, in which case they are in

Class III.

(c) Rule 15

All devices intended specifically to be used for disinfecting, cleaning,

rinsing or, when appropriate, hydrating contact lenses are in Class IIb.

All devices intended specifically to be used for disinfecting medical

devices are in Class IIa, unless they are specifically to be used for

disinfecting invasive devices in which case they are in Class IIb.

This rule does not apply to products that are intended to clean medical

devices other than contact lenses by means of physical action.

(d) Rule 16

Devices specifically intended for recording of X-ray diagnostic images

are in Class IIa.

(e) Rule 17

All devices manufactured utilising animal tissues or derivatives

rendered non-viable are Class III except where such devices are

intended to come into contact with intact skin only.

(f)

Rule 18

By derogation from other rules, blood bags are in Class IIb.

Schedule X

Based on Annex X of Directive 93/42/EEC

CLINICAL EVALUATION

(1)

General provisions

(a) As a general rule, confirmation of conformity with the requirements

concerning the characteristics and performances referred to in sections

1 and 3 of Schedule I, under the normal conditions of use of the device,

and the evaluation of the side-effects and of the acceptability of the

benefit/risk ratio referred to in section 6 of Schedule I, must be based on

clinical data. The evaluation of this data, hereafter referred to as

“clinical evaluation”, where appropriate taking account of any relevant

harmonised standards, must follow a defined and methodologically

sound procedure based on

(i)

either a critical evaluation of the relevant scientific literature

currently available relating to the safety, performance, design

characteristics and intended purpose of the device, where

1. there is demonstration of equivalence of the device to the

device to which the data relates, and

2. the data adequately demonstrate compliance with the relevant

essential requirements.

(ii) or a critical evaluation of the results of all clinical investigations

made,

(iii) or a critical evaluation of the combined clinical data provided in

section 1(a)(i) and (a)(ii).

(b) In the case of implantable devices and devices in Class III clinical

investigations shall be performed unless it is duly justified to rely on

existing clinical data.

(c) The clinical evaluation and its outcome shall be documented. This

documentation shall be included and, or fully referenced in the

technical documentation of the device.

(d) The clinical evaluation and its documentation must be actively updated

with data obtained from the post-market surveillance. Where post-

market clinical follow-up as part of the post-market surveillance plan

for the device is not deemed necessary, this must be duly justified and

documented.

(e) Where demonstration of conformity with essential requirements based

on clinical data is not deemed appropriate, adequate justification for any

such exclusion has to be given based on risk management output and

under consideration of the specifics of the device-body interaction, the

clinical performances intended and the claims of the manufacturer.

Adequacy of demonstration of conformity with the essential

requirements by performance evaluation, bench testing and preclinical

evaluation alone has to be duly substantiated.

(f)

All the data must remain confidential, in accordance with the provisions

of regulation 14(1) and (2).

(2)

Clinical investigations

(a) Objectives

The objectives of clinical investigation are

(i)

to verify that, under normal conditions of use, the performance of

the devices conform to those referred to in section 3 of Schedule I

to these regulations, and

(ii) to determine any undesirable side-effects, under normal

conditions of use, and assess whether they constitute risks when

weighed against the intended performance of the device.

(b) Ethical considerations

Clinical investigations must be carried out in accordance with the

Helsinki Declaration adopted by the 18th World Medical Assembly in

Helsinki, Finland, in 1964, as last amended by the World Medical

Assembly. It is mandatory that all measures relating to the protection of

human subjects are carried out in the spirit of the Helsinki Declaration.

This includes every step in the clinical investigation from first

consideration of the need and justification of the study to publication of

the results.

(c) Methods

(i)

Clinical investigations must be performed on the basis of an

appropriate plan of investigation reflecting the latest scientific

and technical knowledge and defined in such a way as to confirm

or refute the manufacturer's claims for the device; these

investigations must include an adequate number of observations

to guarantee the scientific validity of the conclusions.

(ii) The procedures used to perform the investigations must be

appropriate to the device under examination.

(iii) Clinical investigations must be performed in circumstances

similar to the normal conditions of use of the device.

(iv) All the appropriate features, including those involving the safety

and performances of the device, and its effect on patients, must be

examined.

(v) All serious adverse events must be fully recorded and

immediately notified to the Market Surveillance Directorate and

the Regulatory Affairs Directorate and all competent authorities

of the Member States in which the clinical investigation is being

performed.

(vi) The investigations must be performed under the responsibility of

a medical practitioner or another authorised qualified person in an

appropriate environment.

The medical practitioner or other authorised person must have

access to the technical and clinical data regarding the device.

(vii)

The written report, signed by the medical practitioner or other

authorised person responsible, must contain a critical evaluation

of all the data collected during the clinical investigation.

Schedule XI

Based on Annex XI of Directive 93/42/EEC

CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES

(1) Notified bodies shall be subject to the Method for Designating Conformity

Assessment Bodies Regulations, and they shall also fulfil the criteria set out below.

(2) The notified body, its Director and the assessment and verification staff shall

not be the designer, manufacturer, supplier, installer or user of the devices which

they inspect, nor the authorized representative of any of these persons. They may not

be directly involved in the design, construction, marketing or maintenance of the

devices, nor represent the parties engaged in these activities. This in no way

precludes the possibility of exchanges of technical information between the

manufacturer and the body.

(3) The notified body and its staff must carry out the assessment and

verification operations with the highest degree of professional integrity and the

requisite competence in the field of medical devices and must be free from all

pressures and inducements, particularly financial, which might influence their

judgment or the results of the inspection, especially from persons or groups of

persons with an interest in the results of the verifications.

S ho u l d t h e n o ti f i e d b od y s u bc o nt r a c t s p e c i f i c t a s ks c o nn e c t e d wi t h th e

establishment and verification of the facts, it must first ensure that the subcontractor

meets the provisions of the regulations and, in particular, of this Schedule. The

notified body shall keep at the disposal of the Regulatory Affairs Directorate and the

Market Surveillance Directorate the relevant documents assessing the

subcontractor's qualifications and the work carried out by the subcontractor under

these regulations.

(4) The notified body must be able to carry out all the tasks assigned to such

bodies by one of Schedules II to VI to these regulations and for which it has been

n o t i f i e d , w h e t h e r t h e s e t a s k s a r e c a r r i e d o u t b y t h e b o d y i t s e lf o r o n i t s

responsibility. In particular, it must have the necessary staff and possess the facilities

needed to perform properly the technical and administrative tasks entailed in

assessment and verification. This presupposes the availability of sufficient scientific

staff within the organisation who possess experience and knowledge sufficient to

assess the medical functionality and performance of devices for which it has been

notified, having regard to the requirements of these regulations and, in particular,

those set out in Schedule I. It must also have access to the equipment necessary for

the verifications required.

(5)

The notified body must have

(a) sound vocational training covering all the assessment and verification

operations for which the body has been designated,

(b) satisfactory knowledge of the rules on the inspections which they carry

out and adequate experience of such inspections,

(c) the ability required to draw up the certificates, records and reports to

demonstrate that the inspections have been carried out.

(6) The impartiality of the notified body must be guaranteed. Their

remuneration must not depend on the number of inspections carried out, nor on the

results of the inspections.

(7) The body must take out civil liability insurance, unless liability is assumed

by the State under Maltese legislation or the Regulatory Affairs Directorate and

Market Surveillance Directorate themselves carry out the inspections directly.

(8) The staff of the notified body is bound to observe professional secrecy with

regard to all information gained in the course of their duties (except vis-à-vis the

Regulatory Affairs Directorate or other competent administrative authorities of the

State in which their activities are carried out) pursuant to these regulations or any

provision of national law putting it into effect.

Schedule XII

Based on Annex XII of Directive 93/42/EEC

CE MARKING OF CONFORMITY

The CE conformity marking shall consist of the initials “CE” taking the following

form

For the avoidance of doubt, it is hereby declared that the grid providing the

background in the above graduated drawing is not part of the CE marking.

If the CE marking is reduced or enlarged the proportions given in the above

graduated drawing must be respected. The various components of the CE marking

must have substantially the same vertical dimension, which may not be less than

5mm. This minimum dimension may be waived for small-scale devices.

Schedule XIII

Based on Annex I of Directive 2003/32/EC

RISK ANALYSIS AND RISK MANAGEMENT

(1) Justification for the use of animal tissues or derivatives The manufacturer

must justify, on the basis of his overall risk analysis and risk management strategy

for a specific medical device, the decision to use animal tissues or derivatives,

referred to in the definitions of a “medical device manufactured utilising tissues of

animal origin” and “animal tissues” in article 3 (specifying animal species and

tissues) taking into account the expected clinical benefit, potential residual risk and

suitable alternatives.

(2)

Assessment procedure

In order to ensure a high level of protection for patients or users, the

manufacturer of devices utilising animal tissues or derivatives referred to in section

1(1) must implement an appropriate and well documented risk analysis and risk

management strategy, to address all relevant relating aspects to TSE. He must

identify the hazards associated with those tissues or derivatives, establish

documentation on measures taken to minimise the risk of transmission and

demonstrate the acceptability of the residual risk associated with the device utilising

such tissues or derivatives, taking into account the intended use and the benefit of

the device.

The safety of a device, in terms of its potential for passing on a transmissible

agent, is dependent on all the factors described in section 1(2)(a) to (g), which must

be analysed, evaluated and managed. These measures in combination determine the

device safety.

There are two key steps that must be considered.

These are

(a) selecting starting materials (tissues or derivatives) considered

appropriate regarding their potential contamination with transmissible

agents (see section 1(2)(a) to (c)) taking into account further

processing,

(b) applying a production process to remove or inactivate transmissible

agents on controlled sourced tissues or derivatives (see section 1(2)(d)).

Furthermore, the characteristics of the device and its intended use must be

taken into account (see section 1(2)(e) to (g)).

In performing the risk analysis and risk management strategy, due

consideration must be given to opinions adopted by the relevant scientific

committees, and where appropriate to the opinions of the Committee for Proprietary

Medicinal Products CPMP, the references of which have been published in the

Official Journal of the European Union.

(a) Animals as a source of material

The TSE risk is related to the source species, strains and nature of the

starting tissue. As the accumulation of TSE infectivity occurs over an

incubation period of several years, sourcing from young healthy

animals is considered to be a factor reducing the risk. Risk animals such

as fallen stock, emergency slaughtered and TSE suspected animals must

be excluded.

(b) Geographical sourcing

Pending the classification of countries according to the BSE status in

Regulation (EC) No 999/2001 of the European Parliament and of the

Council of 22 May 2001 laying down rules for the prevention, control

and eradication of certain transmissible spongiform encephalopathies * ,

the Geographical BSE risk (GBR) is used when assessing the risk of the

source country. The GBR is a qualitative indicator of the likelihood of

the presence of one or more cattle being infected with BSE, pre-

clinically as well as clinically, at a given point in time, in a country.

Where presence is confirmed, the GBR gives an indication of the level

of infection as specified in the table below.

GBR level Presence of one or more cattle clinically or pre-clinically

infected with the BSE agent in a geographical region/

country

I

Highly unlikely

II

Unlikely but not excluded

III

Likely but not confirmed or confirmed, at a lower level

IV

Confirmed, at a higher level

Certain factors influence the geographical risk of BSE infection

associated with the use of raw tissues or derivatives from individual

*OJ. L.147, 31-05-2001, p.1.

countries. These factors are defined in article 2.3.13.2, point 1 of the

International Animal Health Code of the OIE (Office International des

Épizooties), which is available at web-site www.oie.int/eng/normes/

Mcode/A_00067.htm

The Scientific Steering Committee has made an assessment of

Geographical BSE Risk (GBR) of several third countries and Member

States, and will continue to do so for all the countries, which applied for

BSE status categorisation, taking the main OIE factors into account.

(c) Nature of starting tissue

The manufacturer must take into account the classification of the

hazards relating to different type of starting tissue. Sourcing of animal

tissue must be subject to control and individual inspection by a

veterinarian and the animal carcass must be certified as fit for human

consumption.

The manufacturer must ensure that no risk of cross-contamination

occurs at the time of slaughtering.

The manufacturer must not source animal tissue or derivatives classified

as potentially high TSE infectivity, unless sourcing of these materials is

necessary in exceptional circumstances, taking into account the

important benefit for the patient and the absence of an alternative

starting tissue.

In addition, the provisions in Regulation (EC) No 1774/2002 of the

European Parliament and of the Council of 3rd October 2002 laying

down health rules concerning animal by-products not intended for

human consumption must be applied.

(i)

Sheep and goats

A classification of infectivity in tissues for sheep and goats has

been established based on actual knowledge on the basis of the

titres of transmissible agents in tissues and body fluids from

naturally infected sheep and goats with clinical scrapie. A table

was presented in the Scientific Steering Committee (SSC) opinion

of 22nd-23rd July 1999 on ‘The policy of breeding and

genotyping of sheep’, (as an annex) * and further updated in the

opinion of the SSC - TSE infectivity distributed in ruminant

tissues state of knowledge December 2001- adopted 10th-11th

January 2002 † .

The classification may be reviewed in the light of new scientific

evidence (for example using relevant opinions from the Scientific

Committees, the Committee for Proprietary Medicinal Products

CPMP and Commission Measures regulating the use of material

presenting risks as regards TSE). A review of the references to

relevant documents/opinions will be published in the Official

Journal of the European Union and will be listed after a

Commission Decision has been taken.

(ii) Cattle

The list of specified risk material (SRM) laid down in Regulation

(EC) No 999/2001 shall be considered as potentially high TSE

infective.

*Available on the website of the Commission http://europa.eu.int/comm/food/fs/sc/ssc/outcome_en.html

†Available on the website of the Commission http://europa.eu.int/comm/food/fs/sc/ssc/outcome_en.html

(d) Inactivation or removal of transmissible agents

(i)

For devices which cannot withstand an inactivation or elimination

process without undergoing unacceptable degradation, the

manufacturer must rely principally on the control of sourcing.

(ii) For other devices, if claims are made by the manufacturer for the

ability of manufacturing processes to remove or inactive

transmissible agents, these will have to be substantiated by

appropriate documentation.

Relevant information from an appropriate scientific literature

search and analysis can be used to support inactivation or

elimination factors, where the specific processes referred to the

literature are comparable to those used for the device. This search

and analysis should also cover the available scientific opinions

that may have been adopted by a EU Scientific Committee. These

opinions shall serve as a reference, in cases where there are

conflicting opinions.

When the literature search failed to substantiate the claims, the

manufacturer must set up a specific inactivation and, or

elimination study on a scientific basis and the following need to

be considered

1. the identified hazard associated with the tissue,

2. identification of the relevant model agents,

3. rationale for the choice of the particular combinations of

model agents,

4. identification of stage chosen to eliminate and, or inactivate

the transmissible agents,

5. calculation of the reduction factors.

A final report must identify manufacturing parameters and limits

that are critical to the effectiveness of the inactivation or

elimination process.

Appropriate documented procedures must be applied to ensure

that the validated processing parameters are applied during

routine manufacture.

(e) Quantities of animal starting tissues or derivatives required to produce

one unit of the medical device

The manufacturer must evaluate the quantity of raw tissues or

derivatives of animal origin required to produce a single unit of the

medical device. Where a purification process is involved, the

manufacturer must assess whether it may have the potential to

concentrate levels of transmissible agents present in the animal starting

tissues or derivatives.

(f)

Tissues or derivatives of animal origin coming into contact with the

patients and users

The manufacturer must consider

(i) the quantity of animal tissues or derivatives;

(ii) the contact area: its surface, type (e.g. skin, mucous tissue, brain)

and condition (e.g. healthy or damaged);

(iii) the type of the tissues or derivatives coming into contact with the

patients and, or users; and

(iv)

how long the device is intended to remain in contact with the

body (including bioresorption effect).

The number of medical devices that could be used in a given procedure

shall be taken into account.

(g) Route of administration

The manufacturer must take into account the route of administration

recommended in the product information, from the highest risk down to

the lowest.

(3)

Review of the assessment

The manufacturer must establish and maintain a systematic procedure to

review information gained about their medical device or similar devices in the post-

production phase. The information must be evaluated for possible relevance to

safety, especially

(a) if previously unrecognised hazards are detected;

(b) if the estimated risk arising from a hazard is no longer acceptable;

(c) if the original assessment is otherwise invalidated.

If any of the above apply, the results of the evaluation shall be fed back as an

input to the risk management process.

In the light of this new information, a review of the appropriate risk

management measures for the device must be considered (including rationale for

choosing an animal tissue or derivative). If there is a potential that the residual risk

or its acceptability has changed, the impact on previously implemented risk control

measures must be re-evaluated and justified.

The results of this evaluation must be documented.

EVALUATION OF CLASS III MEDICAL DEVICES BY NOTIFIED

BODIES

For devices falling into Class III under rule 17 * of Schedule IX to these

regulations, manufacturers must provide to the notified bodies referred to in

regulation 7(6), all relevant information to allow evaluation of their current risk

analysis and risk management strategy. Any new information on TSE risk, collected

by the manufacturer and relevant for their devices must be sent to the notified body

for information.

Any change in relation to processes of sourcing, collection, handling and

inactivation/elimination and that could modify the result of the manufacturer's risk

management dossier must be transmitted to the notified body for the purpose of an

additional approval prior to its implementation.

*All medical devices utilising animal tissue or derivatives rendered non-viable except devices intended to

come into contact with intact skin only.