Active Implantable Medical Devices Regulations, 2008

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 18,308, 12 ta’ Settembru, 2008

L.N. 211 of 2008

PRODUCT SAFETY ACT

(CAP. 427)

Active Implantable Medical Devices Regulations, 2008

IN exercise of the powers conferred by articles 38 to 40 of the

Product Safety Act, the Minister of Finance, Economy and Investment,

on the advice of the Malta Standards Authority, has made the following

regulations>-

(1) The title of these regulations is the Active Implantable Citation and

commencement.

Medical Devices Regulations, 2008.

(2) These regulations transpose the following Directives>

a) Council Directive 90#385#EEC 1 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 2 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) These regulations shall enter into force on the 21 st March,

2010. (4)

The following transitional measures shall remain

applicable>

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.

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

October 2001 in respect of stocks of active implantable medical

devices already placed on the market prior to 1 st April 2001 and

active implantable medical devices ordered before 1 st April 2001

and imported into Malta up to 30 th September 2001< and

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

contracts made before 1 st April 2001, covering the supply of active

implantable medical devices to the Government of Malta over the

period up to and including 31 st December 2002, as well as those

contracts which had terminated before 1 st April 2001 or which,

before 1 st 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.

(1) These regulations shall apply to active implantable

medical devices.

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

Regulatory Affairs Directorate 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 regulations to be applied uniformly, with other Member

States and the Commission.

(b) For the purposes of these regulations, the

Regulatory Affairs Directorate 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 of

these regulations<

“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 to these regulations 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 European Committee for Electrotechnical Standardisation

(CENELEC) or the European Telecommunications Standards

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

accordance with the Notification Procedure Regulations, 2003<

“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) hereof 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<

“Market Surveillance Directorate” means the Market

Surveillance Directorate of the Malta Standards Authority as

described in the Establishment of Directorates of the Malta

Standards Authority Order, 2008<

“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<

“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 to these regulations and

appointed to carry out the procedures referred to in regulations

11(1) to (7) of these regulations. 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.

“Regulatory Affairs Directorate” means the Regulatory

Affairs Directorate of the Malta Standards Authority as described

in the Establishment of Directorates of the Malta Standards L.N. 39 of 2008.

Authority Order, 2008.

(1) Where an active implantable medical device is intended Applicability.

to administer a substance defined as a medicinal product within the

meaning of article 2 of the Medicines Act, that device shall be governed Cap. 458.

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, 2007.

(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 4(2)(b) above<

(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 paragraph 4(2)(b)

above<

(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 to these regulations 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, 2002 L.N. 369 of 2002.

shall also meet the essential health and safety requirements set out in

Schedule I to those regulations to the extent to which those essential

health and safety requirements are more specific than the essential

requirements set out in Schedule 1 to these regulations.

(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) of these regulations must

bear the CE marking of conformity.

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

Schedule IX to these regulations, 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 to

these regulations.

(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 regulation 5(1) above 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

harmonised standards also includes the monographs of the 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 regulations 5(4) to (6) of these regulations,

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

their conformity in accordance with regulations 6(1) to (9) of these

regulations.

(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

regulations 7(1) to (4) and in Schedule VI to these regulations.

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

put into service if they satisfy the conditions laid down in Schedule

VI to these regulations 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 to these regulations

is required to be in, at least, Maltese and, or English.

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

Assessment

made or intended for clinical investigations, the manufacturer must, in Procedures.

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 to these regulations< or

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

set out in Schedule III to these regulations, coupled with>

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

Schedule IV to these regulations, or

(ii) the procedure relating to the EC declaration of

conformity to type set out in Schedule V to these regulations.

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

must draw up the declaration provided for in Schedule VI to these

regulations before placing each device on the market.

(3) Where appropriate, the procedures provided for in

Schedule III, IV and VI to these regulations may be discharged by the

manufacturer’s authorised representative.

(4) The records and correspondence relating to the

procedures referred to in regulations 6(1), (2) and (3) above shall be in,

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

notified body defined in regulations 11(1) to (7) of these regulations.

(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 to these regulations 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 regulations 6(1) and (2) hereof, the

Director of Regulatory Affairs, 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

regulations 6(1) and (2) of these regulations have not been carried out

and the use of which is in the interest of protection of health.

(10) The Regulatory Affairs Directorate 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 regulations 6(1) to (9) above,

by applying solely one of the given procedures chosen from among

those referred to in regulations 6(1) to (9) of these regulations<

(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 60 days

before the commencement of the investigations, submit the statement

referred to in Schedule VI to these regulations to the Regulatory Affairs

Directorate 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 60 days after notification,

unless the Regulatory Affairs Directorate or the Ethics Committee

established by the Clinical Trials Regulations, 2004, have notified him,

within that period, of a decision to the contrary, based on considerations

of public health or public policy.

(b) However, the Regulatory Affairs Directorate may

authorise manufacturers to start the clinical investigations in question

before the expiry of the 60-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 Cap. 465.

Act.

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

the Maltese authorities, the Regulatory Affairs Directorate shall

communicate such decision and the grounds thereof to all Member States

and the Commission. Where the Regulatory Affairs Directorate have

called for a significant modification or temporary interruption of a

clinical investigation, the Regulatory Affairs Directorate 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 Regulatory Affairs Directorate 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. 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 to these

regulations at the disposal of the Market Surveillance Directorate, the

Regulatory Affairs Directorate and the competent authorities of the other

Member States concerned.

(6) Clinical investigations shall be conducted in accordance

with the provisions of Schedule VII to these regulations.

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

prohibition from

definitions of “active implantable medical device” and “custom-made market.

device”, correctly put into service and used in accordance with their

intended purpose, may compromise the health and, or safety of patients,

users or, where applicable, other persons, all appropriate measures shall

be taken by the Market Surveillance Directorate to withdraw such

devices from the market or prohibit or restrict their being placed on the

market or their being put into service.

The Regulatory Affairs Directorate shall immediately inform the

Commission of any such measure, indicating the reasons for such

decision 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 Market Surveillance Directorate shall take appropriate

action against whomsoever has affixed the mark. The Regulatory Affairs

Directorate shall inform the Commission and other Member States of

such actions.

(3) The Market Surveillance Directorate and the Regulatory

Affairs Directorate 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) above, 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) above.

(5) (a) An assessment of the incidents mentioned in sub-

regulation (3) above will be carried out by the Regulatory Affairs

Directorate, if possible together with the manufacturer or his authorised

representative.

(b) The Regulatory Affairs Directorate shall, without

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

Commission and the other Member States of the incidents referred to in

sub-regulation (3) hereof 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 Market Surveillance Directorate

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 Regulatory Affairs Directorate 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) hereof, 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) hereof>

(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 Market

Surveillance Directorate.

(b) where non-compliance continues, all appropriate

measures shall be taken by the Director of Market Surveillance 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) hereof.

(10) The provisions of sub-regulation (9) hereof 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) above

shall inform the Regulatory Affairs Directorate 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

sub-regulation (3)(a) has a registered place of business in Malta, he

shall inform the Regulatory Affairs Directorate of the details referred

to in sub-regulation (1) hereof.

(4) The Regulatory Affairs Directorate shall, on request,

inform the other Member States and the Commission of the details

referred to in sub-regulation (2) hereof 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 to these regulations<

(b) data obtained in accordance with the vigilance procedure

as defined in regulations 8(3) to (5) of these regulations<

(c) data relating to clinical investigations referred to in

regulations 7(1) to (7) of these regulations.

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

Regulatory Affairs Directorate.

(1) The Regulatory Affairs Directorate shall notify the Notified bodies.

Commission and other Member States of the bodies which it has

designated for carrying out the tasks pertaining to the procedures referred

to in regulations 6(1) to (9) of these regulations together with the specific

tasks for which the bodies have been designated.

(2) The Regulatory Affairs Directorate shall apply the

criteria set out in Schedule VIII to these regulations 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 Regulatory Affairs Directorate shall withdraw the

notification if it finds that the body no longer meets the criteria referred

to in sub-regulation (2) hereof. 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 to these regulations.

(5) 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. 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 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 compliance with

the criteria laid down in Schedule VIII to these regulations.

(1) Without prejudice to the existing national provisions

and practices on medical confidentiality, the Market Surveillance

Directorate 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 sub-regulation (1) hereof 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 regulations

9(1) to (4) of these regulations<

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

authorised representative or distributor in relation to a measure in

accordance with regulations 8(3) to (5) of these regulations<

(c) information contained in certificates issued, modified,

supplemented, suspended or withdrawn.

The penalties applicable for the infringement of any of the Penalties.

provisions above shall be those provided for in Part IV of the Product

Safety Act.

The Active Implantable Medical Devices Regulations, 2001 Revokes

L.N. 66 of 2001.

are hereby being revoked.

Schedule I

ESSENTIAL REQUIREMENTS

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 above 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.

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, 2003 and the Ionising

Radiation Medical Exposure Control Regulations, 2004,

(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 above, 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 3 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 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

3 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.

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 patient.

(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) of these

regulations, 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 15(b) above, with the exception of

those referred to in the eighth and ninth indents,

(c) the performances referred to in Section 2 of this Schedule 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 4 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,

4 “Risks of reciprocal interference” means adverse effects on the device caused by instruments present

at the time of investigations or treatment, and vice versa.

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

(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 above, 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 to these regulations.

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 of this

Schedule.

(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 regulations 5(4) to (6) of these regulations 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 post-

market surveillance system including the provision referred to in Schedule

VII to these regulations. 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) below.

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) of these regulations 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 to these regulations 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 to these regulations.

(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) of these regulations, the notified body shall

effect an audit of the quality system to determine whether it meets the

requirements referred to in section 3(b) hereof. 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) hereof; 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) hereof.

(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

sections 3(b)(iii) and (iv) hereof.

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) of these regulations 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 to these

regulations, 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 to these regulations,

(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 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 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 to these

regulations, 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) hereof,

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

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

(v)

the decisions and reports of the notified body referred to in sections 3(d),

4(c), 5(c) and 5(d) of this Schedule.

(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) of these regulations

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

4(2)(b) of these regulations, 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, sub-article (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 of this Schedule 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 above-

mentioned drawings and diagrams and of the operation of the product,

(d) a list of standards referred to in regulation 5(7) of these regulations, 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) of these

regulations 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

to these regulations 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 to these regulations,

(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) of these regulations, 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) of these regulations 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

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 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 to

these regulations, 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

EC VERIFICATION

(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 to these

regulations. This undertaking shall include the obligation on the part of the

manufacturer to notify the Regulatory Affairs Directorate 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 of

this Schedule. The manufacturer must authorise the notified body to evaluate the

efficiency of the measures taken pursuant to section 3 above, 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) of these regulations, 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) of these regulations, 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) of these regulations

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

4(2)(b) of these regulations, 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, sub-article (4) of the Medicines Act.

Schedule V

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

of this Schedule; he shall be subject to the surveillance referred to in section 4 hereof.

(2)

This declaration of conformity is the procedural element whereby the manufacturer

who satisfies the obligations of section 1 hereof 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 regulations 5(4) to (6) of these regulations 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 to these regulations. The undertaking shall include an

obligation for the manufacturer to notify the Regulatory Affairs

Directorate 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) of these regulations, the notified body shall

effect an audit of the quality system to determine whether it meets the

requirements referred to in section 3(b) hereof. 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) hereof; 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) of these regulations

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

4(2)(b) of these regulations, 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, sub-article (4) of the Medicines Act.

Schedule VI

STATEMENT CONCERNING DEVICES INTENDED FOR 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 of this Schedule.

(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 to these regulations 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 VII to

these regulations

(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 to these regulations,

(vii)

a statement indicating whether or not the device is manufactured utilising

tissues of animal origin as referred to in the Medical Devices Regulations,

2008,

(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 Regulatory Affairs

Directorate and the Market Surveillance Directorate

(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) of these regulations, 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) of

these regulations 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 to these regulations, 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) above 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 product.

(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 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 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 paragraph (a) above

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

Schedule VII

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

to these regulations 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 to these regulations, 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 sections

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

(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 to these

regulations,

(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 Market Surveillance Directorate, the Regulatory Affairs

Directorate 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

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, 2003, 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 to these

regulations 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 Regulatory Affairs Directorate 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 Regulatory Affairs

Directorate 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

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.

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