ACTIVE IMPLANTABLE MEDICAL DEVICES REGULATIONS

SUBSIDIARY LEGISLATION 427.10

ACTIVE IMPLANTABLE MEDICAL DEVICES

REGULATIONS

21st March, 2010

LEGAL NOTICE 211 of 2008, as amended by Legal Notice 319 of 2020.

(1) The title of these regulations is Active Implantable

Medical Devices Regulations.

(2)

These regulations transpose the following Directives

(a) Council Directive 90/385/EEC * of 20 June 1990 on the

approximation of the laws of the Member States

relating to active implantable medical devices; and

(b) Directive 2007/47/EC † of the European Parliament

and of the Council of 5 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

shall

remain

applicable

(a) CE marking shall not be obligatory prior to the 1st

October 2001 in respect of stocks of active

implantable medical devices already placed on the

market prior to 1st April 2001 and active implantable

medical devices ordered before 1st April 2001 and

imported into Malta up to 30th September 2001; and

(b) The provisions of these regulations shall not apply to

contracts made before 1st April 2001, covering the

supply of active implantable medical devices to the

Government of Malta over the period up to and

including 31st December 2002, as well as those

contracts which had terminated before 1st April 2001

or which, before 1st April 2001, were determined or

dissolved by agreement or by a judgement which had

become a res judicata, or by operation of the law; in

respect of such contracts the law applicable at the

time, including the time of their termination,

determination or dissolution, shall in so far as

necessary, continue to apply.

*OJ L.189, 20-07-1990, p.17. 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 L.247, 21-09-2007, p.21.

(1) These regulations shall apply to active implantable

medical devices.

(2)

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

Authority will act as the Maltese 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

"active implantable medical device" means any active medical

device which is intended to be totally or partially introduced,

surgically or medically, into the human body or by medical

intervention into a natural orifice, and which is intended to remain

after the procedure;

"active medical device" means any medical device relying for its

functioning on a source of electrical energy or any source of power

other than that directly generated by the human body or gravity;

"authorised representative" means any natural or legal person

established in the Community or Malta who, explicitly designated

by the manufacturer, acts and may be addressed by authorities and

bodies in the Community or Malta instead of the manufacturer with

regard to the latter’s obligations under these regulations;

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

"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 studies 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. 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;

"device intended for clinical investigation" means any device

intended for use by a duly qualified medical practitioner when

conducting clinical investigations as referred to in section 2(a) of

Schedule VII 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;

"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;

"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 material;

"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) 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) paragraph (a) 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, together with any accessories, 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;

"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;

"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 VIII and appointed to carry out the

procedures referred to in regulation 11(1) to (7). 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 making available to the medical

profession for implantation;

(1) Where an active implantable medical device is

intended to administer a substance defined as 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

product.

(2)

(a) Where an active implantable medical 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

human body with action that is ancillary to that of the

device, that device shall be evaluated 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 that is 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.

(3) These regulations constitute a specific Directive within the

meaning of regulation 4(5) of the Electromagnetic Compatibility

Regulations.

(4)

These regulations shall not apply to

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

deciding whether a product falls under that Act or

these regulations, particular account shall be taken of

the principal mode of action of the product;

(b) 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 sub-regulation (2)(b);

(c) transplants or tissues or cells of human origin or to

products incorporating or derived from tissues or cells

of human origin, with the exception of devices

referred to in subregulation (2)(b);

(d) 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.

(1) The active implantable medical devices referred to in

the definitions of "active implantable medical device", "custom-

made device" and "device intended for clinical investigation",

hereinafter referred to as "devices", shall satisfy the essential

requirements set out in Schedule I which apply to them, account

being taken of the intended purpose of the devices concerned.

(2) All necessary steps shall be taken to ensure that the 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, properly implanted and, or properly installed,

maintained and used in accordance with their intended purposes.

(3) Where a relevant hazard exists, devices which also satisfy

the definition of machinery in 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 1.

(4) Devices, other than those which are custom-made or

intended for clinical investigations, considered to meet the

essential requirements referred to in regulation 5(1), must bear the

CE marking of conformity.

(5)

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

IX, must appear in a visible, legible and indelible form

on the sterile pack and, where appropriate, on the sales

packaging, if any, and on the instruction leaflet.

(b) The CE marking must be followed by the

identification number of the notified body responsible

for implementation of the procedures set out in

Schedules II, IV and V.

(6)

It is prohibited to affix markings which are likely to

deceive third parties as to the meaning and form of the CE marking.

Any other marking may be affixed 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.

(7) 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 harmonised standards the reference of which have been

published in the OJ.

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

h armo ni sed sta nd ard s al so in cl ud es t he m on og rap hs of t he

European Pharmacopoeia notably on the interaction between

medicinal products and materials used in devices containing such

medicinal products, the references of which have been published in

the OJ.

(9)

(a) 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 are also presumed to conform to the

provisions of the other Directives.

(b) However, where one or more of these Directives allow

the manufacturer, during a transitional period, to

choose which arrangements to apply, the CE marking

shall indicate conformity to the provisions only of

those Directives applied by the manufacturer. In this

case, particulars of the Directives applied, as

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

notices or instructions required by the Directives and

accompanying such devices; these documents, notices

or instructions shall be accessible without it being

necessary to destroy the packaging which keeps the

device sterile.

(10) Obstacles shall not be created to the placing on the market

or the putting into service within the Maltese territory of devices

complying with the provisions of these regulations and bearing the

CE marking provided for in sub-regulations (4) to (6), which

indicates that they have been the subject of an assessment of their

conformity in accordance with regulation 6(1) to (9).

(11) Obstacles shall not be created to

(a) devices intended for clinical investigations being made

available to duly qualified medical practitioners or

authorised persons for that purpose if they satisfy the

conditions laid down in regulation 7(1) to (4) and in

Schedule VI;

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

put into service if they satisfy the conditions laid down

in Schedule VI and are accompanied by the statement,

which shall be available to the particular identified

patient, referred to in that Schedule.

Such devices shall not bear the CE marking.

(12) At trade fairs, exhibitions, demonstrations, etc., no

obstacles 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 do not conform and cannot be marketed

or put into service until they have been made to comply by the

manufacturer or his authorised representative.

(13) When a device is put into service, the information

described in sections 14, 15, 16 and 17 of Schedule I is required to

be in, at least, Maltese and, or English.

(1) In the case of devices other than those which are

custom-made or intended for clinical investigations, the

manufacturer must, in order to affix the CE marking, at his own

choice

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

conformity set out in Schedule II; or

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

examination set out in Schedule III, coupled with

(i)

the procedure relating to EC verification set out

in Schedule IV, or

(ii) the procedure relating to the EC declaration of

conformity to type set out in Schedule V.

(2) In the case of custom-made devices, the manufacturer must

draw up the declaration provided for in Schedule VI before placing

each device on the market.

(3) Where appropriate, the procedures provided for in Schedule

III, IV and VI may be discharged by the manufacturer’s authorised

representative.

(4) The records and correspondence relating to the procedures

referred to in sub-regulations (1), (2) and (3) shall be in, at least,

Maltese and, or English, and, or in a language acceptable to the

notified body defined in regulation 11(1) to (7).

(5) 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.

(6) 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.

(7) 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.

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

Schedules II, III and V 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.

(9) By derogation from sub-regulations (1) and (2), the

Medicines Authority, after consultation with 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) and (2) have not been carried out and the use of

which is in the interest of protection of health.

(10) The Medicines Authority shall submit a duly substantiated

request to the Commission and ask it to take the necessary

measures in the following situations

(a) the Maltese authorities consider that the conformity of

a device or family of devices should be established, by

way of derogation from the provisions of sub-

regulations (1) to (9), by applying solely one of the

given procedures chosen from among those referred to

in sub-regulations (1) to (9);

(b) the Maltese authorities consider that a decision is

required as to whether a particular product or product

group falls within the definition of "active implantable

medical device", "custom-made device", "device

intended for clinical investigation" or "medical

device".

(1) In the case of devices intended for clinical

investigations, the manufacturer or the authorised representative

shall, at least sixty days before the commencement of the

investigations, submit the statement referred to in Schedule VI to

the Medicines Authority and the competent authorities in other

Member States in which the investigations are to be conducted.

(2)

(a) The manufacturer may commence the relevant clinical

investigations at the end of a period of sixty days after

notification, unless the Medicines Authority or the

Ethics Committee established by the Clinical Trials

Regulations have notified him, within that period, of a

decision to the contrary, based on considerations of

public health or public policy.

(b) However, the Medicines Authority may authorise

manufacturers to start the clinical investigations in

question before the expiry of the sixty-day period,

provided that the Ethics Committee mentioned above

has issued a favourable opinion with respect to the

investigation programme in question, including its

review of the clinical investigation plan.

(3) If necessary, any appropriate steps to ensure public health

and public policy shall be taken according to the Public Health Act.

(4) Where a clinical investigation is refused or halted by the

Maltese authorities, the Medicines Authority shall communicate

such decision and the grounds thereof to all Member States and the

Commission. Where the Medicines Authority have called for a

significant modification or temporary interruption of a clinical

investigation, the Medicines Authority shall inform the Member

States concerned about such actions and the grounds for the actions

taken.

(5) The manufacturer or his authorised representative shall notify

the Medicines Authority and the competent authorities of the Member

States concerned of the end of the clinical investigation, with a

justification in case of early termination. In the case of early

termination of the clinical investigation on safety grounds this

notification shall be communicated to all Member States and the

Commission. The manufacturer or his authorised representative shall

keep the report referred to in section 2(c)(vii) of Schedule VII at the

disposal of the Medicines Authority and the competent authorities of

the other Member States concerned.

(6) Clinical investigations shall be conducted in accordance

with the provisions of Schedule VII.

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

definitions of "active implantable medical device" and "cusom

device", correctly put into service and used in accordance with

their intended purpose, may compromise the health and, or safety

o f p a t i e n t s , u s e r s o r, w h e r e a p p l i c a b l e , o t h e r p e r s o n s , a l l

appropriate 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 their being put into service.

The Medicines Authority shall immediately inform the

Commission of any such measure, indicating the reasons for such

decisions and, in particular, whether non-compliance with these

regulations is due to

(a) failure to meet the essential requirements referred to in

regulation 5(1), where the device does not meet in full

or in part the standards referred to in regulation 5(7);

(b) incorrect application of those standards;

(c) shortcomings in the standards themselves.

(2) Where a device which does not comply bears the CE marking,

the Medicines Authority shall take appropriate action against

whomsoever has affixed the mark. The Medicines Authority shall

inform the Commission and other Member States of such actions.

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

ensure that information brought to their knowledge regarding the

incidents mentioned below involving a device is recorded and

evaluated in a centralised manner

(a) any malfunction of or deterioration in the

characteristics and performances of a device, as well

as any inadequacy in the labelling or 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;

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

characteristics or performances of a device for the

reasons referred to in paragraph (a), leading to

systematic recall of devices of the same type by the

manufacturer.

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

manufacturer of the device concerned, or his authorised

representative, is also informed of the incident referred to in sub-

regulation (3).

(5)

(a) An assessment of the incidents mentioned in

subregulation (3) will be carried out by the Medicines

Authority, if possible together with the manufacturer or

his authorised representative.

(b) The Medicines Authority shall, without prejudice to

sub-regulations (1) and (2), immediately inform the

Commission and the other Member States of the

incidents referred to in sub-regulation (3) and of the

measures that have been taken or are contemplated to

minimise the recurrence of such incidents, including

information on the underlying incidents.

(6)

(a) 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.

(b) The Medicines Authority shall then inform the

Commission and all other Member States of these

transitional measures, giving the reasons for such

decisions.

(7)

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.

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

(7), the manufacturer or his authorised representative 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.

(9)

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

(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;

(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) and (2).

(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.

(1) 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 procedure referred to in regulation

6(2) shall inform the Medicines Authority of the address of the

registered place of business and the description of the devices

concerned.

(2) All data allowing for the devices to be identified, together

with the label and instructions for use, may be requested when such

devices are put into service in Malta.

(3)

(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 in

paragraph (a) has a registered place of business in

Malta, he shall inform the Medicines Authority of the

details referred to in sub-regulation (1).

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

Member States and the Commission of the details referred to in

sub-regulation (2) given 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.

(2)

The databank shall contain the following

(a) data relating to certificates issued, modified,

supplemented, suspended, withdrawn or refused

according to the procedures as laid down in Schedules

II to V;

(b) data obtained in accordance with the vigilance

procedure as defined in regulation 8(3) to (5);

(c) data relating to clinical investigations referred to in

regulation 7(1) to (7).

(3)

Data shall be forwarded in a standardised format by the

Medicines Authority.

(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 (9) together with the specific tasks for which the

bodies have been designated.

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

Schedule VIII 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 if it

finds that the body no longer meets the criteria referred to in 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 evaluation and verification operations

referred to in Schedules II to V.

(5) The notified body shall inform the Medicines Authority

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

Provided that, 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

Medicines Authority thereof. The Medicines Authority

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 Medicines Authority to verify compliance

with the criteria laid down in Schedule VIII.

(1) Without prejudice to the existing national provisions

and practices on medical confidentiality, 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

Provided that the provisions of this sub-regulation do not

affect the obligation of the above authority with regard to mutual

information and the dissemination of warnings, nor the obligations

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 9(1) to (4);

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

authorised representative or distributor in relation to a

measure in accordance with regulation 8(3) to (5);

(c) information contained in certificates issued, modified,

supplemented, suspended or withdrawn.

Deleted by Legal Notice 319 of 2020.

Schedule I

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 laid down, their use does not

compromise the clinical condition or the safety of patients. They must not present

any risk to the persons implanting them or, where applicable, to other persons.

(2) The devices must achieve the performances intended by the manufacturer,

namely that they are designed and manufactured in such a way that they are suitable

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

specified by him.

(3) The characteristics and performances referred to in sections 1 and 2 must

not be adversely affected to such a degree that the clinical condition and safety of

the patients or, as appropriate, of other persons are compromised during the lifetime

of the device anticipated by the manufacturer, where the device is subjected to

stresses which may occur during normal conditions of use.

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

their characteristics and performances are not adversely affected in the storage and

transport conditions laid down by the manufacturer (temperature, humidity, etc.).

(5) Any side effects or undesirable conditions must constitute acceptable risks

when weighed against the performances intended.

(6) Demonstration of conformity with the essential requirements must include a

clinical evaluation in accordance with Schedule VII to these regulations.

II

REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

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

of the devices must comply with safety principles taking account of the generally

acknowledged state of the art.

(8) Implantable devices must be designed, manufactured and packed in a non-

reusable pack according to appropriate procedures to ensure they are sterile when

placed on the market and, in the storage and transport conditions stipulated by the

manufacturer, remain so until the packaging is removed and they are implanted.

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

minimise as far as possible

(a) the risk of physical injury in connection with their physical, including

dimensional, features,

(b) risks connected with the use of energy sources with particular reference,

where electricity is used, to insulation, leakage currents and overheating

of the devices,

(c) risks connected with reasonably foreseeable environmental conditions

such as magnetic fields, external electrical influences, electrostatic

discharge, pressure or variations in pressure and acceleration,

(d) risks connected with medical treatment, in particular those resulting

from the use of defibrillators or high-frequency surgical equipment,

(e) risks connected with ionising radiation from radioactive substances

included in the device, in compliance with the protection requirements

laid down in the Nuclear Safety and Radiation Protection Regulations,

and the Ionising Radiation Medical Exposure Control Regulations,

(f)

risks which may arise where maintenance and calibration are

impossible, including

(i)

excessive increase of leakage currents,

(ii)

ageing of the materials used,

(iii)

excess heat generated by the device,

(iv)

decreased accuracy of any measuring or control mechanism.

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

guarantee the characteristics and performances referred to in sections 1 to 6, with

particular attention being paid to

(a) the choice of materials used, particularly as regards toxicity aspects,

(b) mutual compatibility between the materials used and biological tissues,

cells and body fluids, account being taken of the anticipated use of the

device,

(c) compatibility of the devices with the substances they are intended to

administer,

(d) the quality of the connections, particularly in respect of safety,

(e) the reliability of the source of energy,

(f)

if appropriate, that they are leak proof,

(g) proper functioning of the programming and control system, including

software. 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.

(11) 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.

(a) 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.

(b) 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 device and taking account of the intended

*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, 30-04-2004, p.1). Regulation as

last amended by Regulation (EC) No. 1901/2006.

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.

(c) 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

competent authority (i.e. 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 the 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 device.

(d) When the relevant competent authority (i.e. 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 to the 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 to the device or not. The notified body shall take the updated

scientific opinion into account in reconsidering its assessment of the

conformity assessment procedure.

(12) The devices and, if appropriate, their component parts must be identified to

allow any necessary measure to be taken following the discovery of a potential risk

in connection with the devices and their component parts.

(13) Devices must bear a code by which they and their manufacturer can be

unequivocally identified (particularly with regard to the type of device and year of

manufacture); it must be possible to read this code, if necessary, without the need for

a surgical operation.

(14) When a device or its accessories bear instructions required for the operation

of the device or indicate operating or adjustment parameters, by means of a visual

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

(15) Every device must bear, legibly and indelibly, the following particular,

where appropriate in the form of generally recognised symbols

(a) On the sterile pack

(i)

the method of sterilisation,

(ii)

an indication permitting this packaging to be recognised as such,

(iii)

the name and address of the manufacturer,

(iv)

a description of the device,

(v)

if the device is intended for clinical investigations, the words

"exclusively for clinical investigations",

(vi)

if the device is custom-made, the words "custom-made device",

(vii) a declaration that the implantable device is in a sterile condition,

(viii) the month and year of manufacture,

(ix)

an indication of the time limit for implanting a device safely,

(b) On the sales packaging

(i)

the name and address of the manufacturer and 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) a description of the device,

(iii) the purpose of the device,

(iv) the relevant characteristics for its use,

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

"exclusively for clinical investigations",

(vi) if the device is custom-made, the words: "custom-made device",

(vii)

a declaration that the implantable device is in a sterile condition,

(viii)

the month and year of manufacture,

(ix)

an indication of the time limit for implanting a device safely,

(x)

the conditions for transporting and staring the device,

(xi)

in the case of device within the meaning of regulation 4(2)(a), an

indication that the device contains a human blood derivative.

(16) When placed on the market each device must be accompanied by

instructions for use giving the following particulars

(a) the year of authorisation to affix the CE mark,

(b) the details referred to in sections 15(a) and (b), with the exception of

those referred to in the eighth and ninth indents,

(c) the performances referred to in section 2 and any undesirable side

effects,

(d) information allowing the physician to select a suitable device and the

corresponding software and accessories,

(e) information constituting the instructions for use allowing the physician

and, where appropriate, the patient to use the device, its accessories and

software correctly, as well as information on the nature, scope and times

for operating controls and trials and, where appropriate, maintenance

measures,

(f)

information allowing, if appropriate, certain risks in connection with

implantation of the device to be avoided,

(g) information regarding the risks of reciprocal interference * in connection

with the presence of the device during specific investigations or

treatment,

(h) the necessary instructions in the event of the sterile pack being damaged

and, where appropriate, details of appropriate methods of re-

sterilisation,

(i)

an indication, if appropriate, that a device can be reused only if it is

reconditioned under the responsibility of the manufacturer to comply

with the essential requirements,

(j)

date of issue or the latest revision of the instructions for use.

*"Risks of reciprocal interference" means adverse effects on the device caused by instruments present at the

time of investigations or treatment, and vice versa.

(17) The instruction leaflet must also include details allowing the physician to

brief the patient on the contra-indications and the precautions to be taken. These

details should cover in particular

(a) information allowing the lifetime of the energy source to be established,

(b) precautions to be taken should changes occur in the device’s

performance,

(c) 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, etc.,

(d) adequate information regarding the medicinal products which the device

in question is designed to administer.

(18) Confirmation that the device satisfies the requirements in respect of

characteristics and performances, as referred to in sections 1 to 6, in normal

conditions of use, and the evaluation of the side effects or undesirable effects must

be based on clinical data established in accordance with Schedule VII.

Schedule II

EC DECLARATION OF CONFORMITY

(Complete quality assurance system)

(1) The manufacturer shall apply the quality system approved for the design,

manufacture and final inspection of the products concerned as specified in sections 3

and 4 and shall be subject to EC surveillance as specified in section 5.

(2) The declaration of conformity is the procedure by means of which the

manufacturer who satisfies the obligations of Section 1 above ensures and declares

that the products concerned meet the provisions of these regulations which apply to

them.

The manufacturer or his authorised representative shall affix the CE marking

in accordance with regulation 5(4) to (6) and shall draw up a written declaration of

conformity.

This declaration shall cover one or more clearly identified devices by means

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

the manufacturer.

The CE marking shall be accompanied by the identification number of the

notified body responsible.

(3)

Quality system

(a) The manufacturer shall make an application for evaluation of his quality

system to a notified body.

The application shall include

(i)

all the appropriate items of information for the category of

products manufacture of which is envisaged,

(ii) the quality-system documentation,

(iii) an undertaking to fulfil the obligations arising from the quality

system as approved,

(iv)

an undertaking to maintain the approved quality system in such a

way that it remains adequate and efficacious,

(v)

an undertaking by the manufacturer to institute and keep updated

a postmarket surveillance system including the provision referred

to in Schedule VII. The undertaking shall include an obligation

for the manufacturer to notify the competent authorities of the

following incidents immediately on learning of them

1. any deterioration in the characteristics or performances, and

any inaccuracies in the instruction leaflet for a device which

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

deterioration in his state of health;

2. any technical or medical reason resulting in withdrawal of a

device from the market by the manufacturer.

(b) The application of the quality system must ensure that the products

confirm to the provision of these regulations which apply to them at

every stage, from design to final controls.

All the elements, requirements and provisions adopted by the

manufacturer for his quality system shall be documented in a systematic

and orderly manner in the form of written policies and procedures. This

quality-system documentation must make possible a uniform

interpretation of the quality 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 point (iii) hereunder.

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 the design and of the products, including

control of products which do not 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 and in particular

1. the design specifications, including the standards which will

be applied and a description of the solutions adopted to fulfil

the essential requirements which apply to the products when

the standards referred to in regulation 5(7) are not applied in

full,

2. the techniques of control and verification of the design, the

processes and systematic actions which will be used when

the products are being designed,

3. a statement indicating whether or not the device

incorporates, as an integral part, a substance or a human

blood derivative referred to in section 11 of Schedule 1 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,

4. the pre-clinical evaluation,

5. the clinical evaluation referred to Schedule VII;

(iv)

the techniques of control and of quality assurance 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. 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 effected before,

during and after production, the frequency with which they will

take place, and the test equipment used.

(c) Without prejudice to regulation 8(9), the notified body shall effect an

audit of the quality system to determine whether it meets the

requirements referred to in section 3(b). It shall presume conformity

with these requirements for the quality systems which use the

corresponding harmonised standards.

The team entrusted with the evaluation shall include at least one

member who has already had experience of evaluations of the

technology concerned. The evaluation procedure shall include 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.

The decision shall be notified to the manufacturer after the final

inspection. It shall contain the conclusions of the control and a reasoned

evaluation.

(d) The manufacturer shall inform the notified body which has approved the

quality system of any plan to alter the quality system.

The notified body shall evaluate the proposed modifications and shall

verify whether the quality system so modified would meet the

requirements referred to in section 3(b); it shall notify the manufacturer

of its decision. This decision shall contain the conclusions of the control

and a reasoned evaluation.

(4)

Examination of the design of the product

(a) In addition to the obligations incumbent on him under section 3, the

manufacturer shall make 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 shall describe the design, manufacture, and

performances of the product in question, and it must include the

documents needed to assess whether the product conforms to the

requirements of these regulations, and in particular section 3(b)(iii) and

(iv).

It shall include inter alia

(i)

the design specifications, including the standards which have

been applied,

(ii) the necessary proof of their appropriations, in particular where

the standards referred to in regulation 5(7) have not been applied

in full. This proof must include the results of the appropriate tests

carried out by the manufacturer or carried out under his

responsibility,

(iii) a statement as to whether or not the device incorporates, as an

integral part, a substance as referred to in section 11 of Schedule

I, whose action in combination with the device may result in its

bioavailability, together with data on the relevant trials

conducted,

(iv) the clinical evaluation referred to in Schedule VII,

(v) the draft instruction leaflet.

(c) The notified body shall examine the application and, where the product

complies with the relevant provisions of these regulations, shall issue

the applicant with an EC design examination certificate. The notified

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

proof so that compliance with the requirements of the regulations may

be evaluated. The certificate shall contain the conclusions of the

examination, the conditions of its validity, the data needed for

identification of the approved design and, where appropriate, a

description of the intended use of the product.

In the case of devices referred to in section 11(a) of Schedule I, 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 shall 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.

In the case of devices referred to in section 11(b) of Schedule I, the

scientific opinion of the EMEA must be included in the documentation

concerning the device. The opinion shall 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) The applicant shall inform the notified body which issued the EC design

examination certificate of any modification made to the approved

design. Modifications made to the approved design must obtain

supplementary approval from the notified body which issued the EC

design examination certificate where such modifications may affect

conformity with the essential requirements of these regulations or the

conditions prescribed for the use of the product. This supplementary

approval shall be given in the form of an addendum to the EC design

examination certificate.

(5)

Surveillance

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

the obligations arising from the approved quality system.

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

necessary inspections and shall supply it with all appropriate

information, in particular

(i) the quality-system documentation,

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

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

preclinical 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 reports concerning inspections, tests,

standardisations, calibrations and the qualifications of the staff

concerned, etc.

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

and evaluations in order to ascertain that the manufacturer is applying

the approved quality system, and shall supply the manufacturer with an

evaluation report.

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

manufacturer, and shall supply him with an inspection report.

(6)

Administrative provisions

(a) For at least fifteen years from the last date of manufacture of the

product, the manufacturer or his authorised representative shall keep

available for the Regulatory Affairs Directorate and the Market

Surveillance Directorate

(i) the declaration of conformity,

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

the documentation, data and records referred to in the second

paragraph of section 3(b),

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

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

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

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

(b) On request, the notified body shall make available to the other notified

bodies and Regulatory Affairs Directorate and the Market Surveillance

Directorate all relevant information on approvals of quality systems

issued, refused or withdrawn.

(7)

Application to devices referred to in regulation 4(2)(b)

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

regulation 4(2)(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

EC TYPE-EXAMINATION

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

certifies that a representative sample of the production envisaged satisfies the

relevant provisions of these regulations.

(2) The application for EC type-examination shall be made by the manufacturer,

or by his authorised representative, to a notified body.

The application shall include

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

the authorised representative if the application is made by the latter,

(b) a written declaration specifying that an application has not been made to

any other notified body,

(c) the documentation described in section 3 needed to allow an evaluation

to be made of the conformity of a representative sample of the

production in question, hereinafter referred to as "type", with the

requirements of these regulations.

The applicant shall make a "type" available to the notified body. The

notified body may request other samples as necessary.

(3) The documentation must make it possible to understand the design, the

manufacture and the performances of the product. The documentation shall contain

the following items in particular

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

intended use,

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

regards sterilisation, and diagrams of parts, sub-assemblies, circuits,

etc.,

(c) the descriptions and explanations necessary for the understanding of the

abovementioned drawings and diagrams and of the operation of the

product,

(d) a list of standards referred to in regulation 5(7), applied in full or in

part, and a description of the solutions adopted to satisfy the essential

requirements where the standards referred to in regulation 5(7) have not

been applied,

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

technical tests carried out, etc.,

(f)

a declaration stating whether or not the device incorporates, as an

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

section 11 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,

(g) the pre-clinical evaluation,

(h) the clinical evaluation referred to in Schedule VII,

(i)

the draft instruction leaflet.

(4)

The notified body shall

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

manufactured in accordance with that documentation; it shall also

record the items which have been designed in accordance with the

applicable provisions of the standards referred to in regulation 5(7), as

well as the items for which the design is not based on the relevant

provisions of the said standards;

(b) carry out or have carried out the appropriate inspections and the tests

necessary to verify whether the solutions adopted by the manufacturer

satisfy the essential requirements of these regulations where the

standards referred to in regulation 5(7) have not been applied;

(c) carry out or have carried out the appropriate inspections and the tests

necessary to verify whether, where 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) Where the type meets the provisions of these regulations, the notified body

shall issue an EC type-examination certificate to the applicant. The certificate shall

contain the name and address of the manufacturer, the conclusions of the control, the

conditions under which the certificate is valid and the information necessary for

identification of the type approved.

The significant parts of the documentation shall be attached to the certificate

and a copy shall be kept by the notified body.

In the case of devices referred to in the second paragraph of section 11 of

Schedule I, 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 shall 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.

In the case of devices referred to in the third paragraph, section 11 of

Schedule I, the scientific opinion of the EMEA must be included in the

documentation concerning the device. The opinion shall 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.

(6) The applicant shall inform the notified body which issued the EC type-

examination certificate of any modification made to the approved product.

Modifications to the approved product must receive further approval from

the notified body which issued the EC type-examination certificate where such

modifications may affect conformity with the essential requirements or with the

conditions of use specified for the product. This new approval shall be issued, where

appropriate, in the form of a supplement to the initial EC type-examination

certificate.

(7)

Administrative provisions

(a) On request, each notified body shall make available to the other notified

bodies and the competent authority, all relevant information on EC

type-examination

certificates

and

addenda

issued,

refused

or

withdrawn.

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

certificates and, or the addenda to them. The annexes to the certificates

shall be made available to the other notified bodies when a reasoned

application is made and after the manufacturer has been informed.

(c) The manufacturer or his authorised representative shall keep with the

technical documentation a copy of the EC type-examination certificates

and the supplements to them for a period of at least 15 years from the

manufacture of the last product.

Schedule IV

Amended by

EC VERIFICATION

L.N. 319 of 2020.

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

representative ensures and declares that the products subject to the provisions of

section 3 below are in conformity with the type as described in the EC type-

examination certification and satisfy the requirements of these regulations that apply

to them.

(2) The manufacturer or his authorised representative shall take all measures

necessary in order that the manufacturing process ensures conformity of the products

to the type as described in the EC type-examination certification and to the

requirements of these regulations that apply to them. The manufacturer or his

authorised representative shall affix the CE marking to each product and draw up a

written declaration of conformity.

(3) The manufacturer shall, before the start of manufacture, prepare documents

defining the manufacturing processes, in particular as regards sterilisation, together

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

uniformity of production and conformity of the products with the type as described

in the EC type-examination certificate as well as with the relevant requirements of

these regulations.

(4) The manufacturer shall undertake to institute and keep updated a post-

marketing surveillance system including the provisions referred to in Schedule VII.

This undertaking shall include the obligation on the part of the manufacturer to

notify the Medicines Authority of the following events immediately on learning of

them

(a) any change in the characteristics or performances and any inaccuracies

in the instruction leaflet for a device which might lead to or have led to

the death of a patient or deterioration in his state of health;

(b) any technical or medical reason resulting in the withdrawal of a device

from the market by a manufacturer.

(5) The notified body shall carry out the appropriate examinations and tests in

order to check the conformity of the product to the requirements of these regulations

by examination and testing of products on a statistical basis, as specified in section

6. The manufacturer must authorise the notified body to evaluate the efficiency of

the measures taken pursuant to section 3, by audit where appropriate.

(6)

Statistical verification

(a) Manufacturers shall present the products manufactured in the form of

uniform batches and shall take all necessary measures in order that the

manufacturing process ensures the uniformity of each batch produced.

(b) A random sample shall be taken from each batch. Products in a sample

shall be individually examined and appropriate tests, as set out in any

standard referred to in regulation 5(7), or equivalent tests shall be

carried out to verify their conformity to the type as described in the EC

type-examination certificate and thereby determine whether a batch is

to be accepted or rejected.

(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(7), taking account of

the specific nature of the product categories in question.

(d) Where batches are accepted, the notified body shall affix, or cause to be

affixed, its identification number to each product and draw up a written

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

the batch may be placed on the market except for those products from

the sample which were found not to be in conformity.

Where a batch is rejected, the notified body shall take appropriate

measures to prevent the placing on the market of that batch. In the event

of frequent rejection of batches the notified body may suspend the

statistical verification.

The manufacturer may, under the responsibility of the notified body,

affix the latter's identification number during the manufacturing

process.

(e) The manufacturer or his authorised representative shall ensure that he is

able to supply the notified body’s certificates of conformity on request.

(7)

Application to the devices referred to in regulation 4(2)(b)

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

regulation 4(2)(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 V

Amended by

L.N. 319 of 2020.

EC DECLARATION OF CONFORMITY TO TYPE

(Assurance of production quality)

(1) The manufacturer shall apply the quality system approved for the

manufacture and shall conduct the final inspection of the products concerned as

specified in section 3; he shall be subject to the surveillance referred to in section 4.

(2) This declaration of conformity is the procedural element whereby the

manufacturer who satisfies the obligations of section 1 guarantees and declares that

the products concerned conform to the type described in the EC type-examination

certificate and meet the provisions of the regulations which apply to them.

(a) The manufacturer or his authorised representative shall affix the CE

marking in accordance with regulation 5(4) to (6) and draw up a written

declaration of conformity. This declaration shall cover one or more

devices manufactured, clearly identified by means of product name,

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

manufacturer. The CE marking shall be accompanied by the

identification number of the notified body responsible.

(3)

Quality system

(a) The manufacturer shall make an application for evaluation of his quality

system to a notified body.

The application shall include

(i)

all appropriate information concerning the products which it is

intended to manufacture,

(ii) the quality-system documentation,

(iii) an undertaking to fulfil the obligations arising from the quality

system as approved,

(iv) an undertaking to maintain the approved quality system in such a

way that it remains adequate and efficacious,

(v) where appropriate, the technical documentation relating to the

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

(vi) an undertaking by the manufacturer to institute and keep up-dated

a post-marketing surveillance system including the provisions

referred to in Schedule VII. The undertaking shall include an

obligation for the manufacturer to notify the Medicines Authority

of the following incidents immediately on learning of them

1. any deterioration in the characteristics or performances, and

any inaccuracies in the instruction leaflet for a device which

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

deterioration in his state of health;

2. any technical or medical reason resulting in withdrawal of a

device from the market 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 shall be documented in a systematic

and orderly manner in the form of written policies and procedures. This

quality-system documentation must make possible a uniform

interpretation of the quality policies and procedures such as quality

programmes, quality plans, quality manuals and quality records.

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

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 the products, including control of products

which do not conform,

3. where the 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 techniques of control and of quality assurance 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. 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 which will be effected before,

during and after production, the frequency with which they will

take place, and the test equipment used.

(c) Without prejudice to regulation 8(9), the notified body shall effect an

audit of the quality system to determine whether it meets the

requirements referred to in section 3(b). It shall presume conformity

with these requirements for the quality systems which use the

corresponding harmonised standards.

The team entrusted with the evaluation shall include at least one

member who has already had experience of evaluations of the

technology concerned. The evaluation procedure shall include an

inspection on the manufacturer's premises.

The decision shall be notified to the manufacturer after the final

inspection. It shall contain the conclusions of the control and a reasoned

evaluation.

(d) The manufacturer shall inform the notified body which has approved the

quality system of any plan to alter that system.

The notified body shall evaluate the proposed modifications and shall

verify whether the quality system so modified would meet the

requirements referred to in section 3(b); it shall notify the manufacturer

of its decision. This decision shall contain the conclusions of the control

and a reasoned evaluation.

(4)

Surveillance

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

the obligations arising from the approved quality system.

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

necessary inspections and shall supply it with all appropriate

information, in particular

(i) the quality-system documentation,

(ii) the technical documentation,

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

manufacture, such as reports concerning inspections, tests,

standardisations, calibrations and the qualifications of the staff

concerned, etc.

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

and evaluations in order to ascertain that the manufacturer is applying

the approved quality system, and shall supply the manufacturer with an

evaluation report.

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

manufacturer, and shall supply him with an inspection report.

(5) The notified body shall communicate to the other notified bodies all relevant

information concerning approvals of quality systems issued, refused or withdrawn.

(6)

Application to the devices referred to in regulation 4(2)(b)

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

regulation 4(2)(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

Amended by

STATEMENT CONCERNING DEVICES INTENDED FOR

L.N. 319 of 2020.

SPECIAL PURPOSES

(1) The manufacturer or his authorised representative shall draw up for custom-

made devices or for devices intended for clinical investigations the statement

comprising the elements 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) the information necessary for the identification of the product in

question,

(iii) the name of the duly qualified medical practitioner who drew up

the prescription and, if applicable, the name of the clinic

concerned,

(iv)

the specific characteristics of the product revealed by the

prescription,

(v)

a statement affirming that the device complies with the essential

requirements given in Schedule I and, where applicable,

indicating which essential requirements have not been wholly

met, together with the grounds;

(b) for devices intended for the clinical investigations covered in Schedule

(i)

data allowing the devices in question to be identified,

(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 11 of Schedule I,

(vii)

a statement indicating whether or not the device is manufactured

utilising tissues of animal origin as referred to in the Medical

Devices Regulations,

(viii) the opinion of the Ethics Committee concerned and details of the

aspects covered by its opinion,

(ix) the name of the duly qualified medical practitioner or other

authorised person and of the institution responsible for the

investigations,

(x) the place, date of commencement and duration scheduled for the

investigations,

(xi) a statement affirming that the device in question complies with

the essential requirements apart from the aspects constituting the

object of 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 Medicines

(a) for custom-made devices, documentation, indicating manufacturing

sites and enabling the design, manufacture and performances of the

product, including the expected performances, to be understood, so as to

allow conformity with the requirements of these regulations to be

assessed.

The manufacturer shall take all necessary measures to see that the

manufacturing process ensures that the products manufactured conform

to the documentation referred to in the first paragraph;

(b) for devices intended for clinical investigations, the documentation shall

also contain

(i) a general description of the product and its intended use,

(ii) design drawings, manufacturing methods, in particular as regards

sterilisation, and diagrams of parts, sub-assemblies, circuits, etc.,

(iii) the descriptions and explanations necessary for the understanding

of the said 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(7), applied in full or in part, and descriptions of

the solutions adopted to satisfy the essential requirements of these

regulations where the standards referred to in regulation 5(7) have

not been applied,

(v) if the device incorporates, as an integral part, a substance or

human blood derivative referred to in section 11 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) the results of the design calculations, checks and technical tests

carried out, etc.

The manufacturer shall take all the measures necessary to see that the

manufacturing process ensures that the products manufactured conform

to the documentation referred to in section 3(a) and in the first

paragraph of this section.

The manufacturer may authorise the evaluation, by audit where

necessary, of the effectiveness of these measures.

(4) The information included in the declarations covered by this Schedule shall

be kept for a period of at least 15 years from the data of manufacture of the last

(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 VII, and to implement appropriate means to apply any

necessary corrective action. This undertaking must include an obligation for the

manufacturer to notify the Medicines Authority 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 paragraph (a)

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

manufacturer.

Schedule VII

Amended by

L.N. 319 of 2020.

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 2 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 and risk ratio referred to in section 5 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 the clinical

investigations made,

(iii) or a critical evaluation of the combined clinical data provided in

section 1(a)(i) and (ii).

(b) 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 data must remain confidential unless it is deemed essential that they

be divulged.

(2)

Clinical investigations

(a) Purpose

The purpose of a clinical investigation is to

(i)

verify that, under normal conditions of use, the performance of

the device comply with those indicated to in section 2 of Schedule

I,

(ii) 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 consideration

Clinical investigations shall be made in accordance with the Declaration

of Helsinki approved by the 18th World Medical Assembly in Helsinki,

Finland, in 1964, and amended by the 29th World Medical Assembly in

Tokyo, Japan, in 1975 and the 35th World Medical Assembly in Venice,

Italy, in 1983. It is mandatory that all measures relating to the

protection of human subjects are carried out in the spirit of the

Declaration of Helsinki. This includes every step in the clinical

investigation from first consideration of need and justification of the

study to publication of results.

(c) Methods

(i)

Clinical investigations shall be performed according to an

appropriate state of the art plan of investigation defined in such a

way as to confirm or refute the manufacturer’s claims for the

device; the investigations shall include an adequate number of

observations to guarantee the scientific validity of the

conclusions.

(ii) The procedures utilised to perform the investigations shall be

appropriate to the device under examination.

(iii) Clinical investigations shall be performed in circumstances

equivalent to those which would be found in 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, shall be

examined.

(v) All serious adverse events must be fully recorded and

immediately notified to the Medicines Authority and all competent

authorities of the Member States in which the clinical

investigation is being performed.

(vi) The investigations shall be performed under the responsibility of

a duly qualified medical practitioner or authorised person, in an

appropriate environment.

The medical practitioner or authorised person shall have access to

the technical data regarding the device.

(vii)

The written report, signed by the responsible medical practitioner

or authorised person, shall comprise a critical evaluation of all the

data collected during the clinical investigation.

Schedule VIII

Amended by

L.N. 319 of 2020.

MINIMUM CRITERIA TO BE MET WHEN DESIGNATING

INSPECTION BODIES TO BE NOTIFIED

(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 body, its director and the staff responsible for carrying out the

evaluation and verification operations shall not be the designer, manufacturer,

supplier or installer of devices which they control, nor the authorised representative

of any of those parties. They may not become directly involved in the design,

construction, marketing or maintenance of the devices, nor represent the parties

engaged in these activities. This does not preclude the possibility of exchanges of

technical information between the manufacturer and the body.

(3) The body and its staff must carry out the evaluation and verification

operations with the highest degree of professional integrity and technical

competence and must be free from all pressures and inducements, particularly

financial, which might influence their judgement or the results of the inspection,

especially from persons or groups of persons with an interest in the results of

verifications.

(4) The body must be able to carry out all the tasks in one of Schedules II to V

assigned to such a body and for which it has been notified, whether those tasks are

carried out by the body itself or under its responsibility. In particular, it must have at

its disposal the necessary staff and possess the necessary facilities to enable it to

perform properly the technical and administrative tasks connected with evaluation

and verification; it must also have access to the equipment necessary for the

verifications required.

(5)

The staff responsible for control operations must have

(a) sound vocational training covering all the evaluation and verification

operations for which the body has been designated,

(b) satisfactory knowledge of the requirements of the controls they carry

out and adequate experience of such operations,

(c) the ability required to draw up the certificates, records and reports to

demonstrate that the controls have been carried out.

(6) The impartiality of inspection staff must be guaranteed. Their remuneration

must not depend on the number of controls carried out, nor on the results of such

controls.

(7) The body must take out liability insurance unless liability is assumed by the

State in accordance with Maltese law, or the Medicines Authority itself are directly

responsible for controls.

(8) The staff of the body is bound to observe professional secrecy with regard to

all information gained in carrying out their tasks (except vis-à-vis the Medicines

Authority or other competent administrative authorities of the State in which their

activities are carried out) under these regulations or any provision of national law

giving effect to it.

Schedule IX

CE CONFORMITY MARKING

The CE conformity marking shall consist of the initials “CE” taking the following

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.