1990L0385 — EN — 20.11.2003 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of20June1990
on the approximation of the laws of the Member States relating to active implantable medical
devices
(90/385/EEC)
(OJ L 189, 20.7.1990, p. 17)
Amended by:
Official Journal
No page date
►M1Council Directive 93/42/EEC of 14 June 1993 L 169 1 12.7.1993
►M2Council Directive 93/68/EEC of 22 July 1993 L 220 1 30.8.1993
►M3Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003L 284 1 31.10.2003
Corrected by:
►C1Corrigendum, OJ L 7, 1.11.1994, p. 20 (90/385/EEC)
▼B
COUNCILDIRECTIVE
of20June1990
on the approximationof the lawsofthe Member States relating to
activeimplantablemedical devices
(90/385/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation withth e European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas in each Member State active implantable medical devices
must give patients, users and other persons a high level of protectionand achieve the intended level of performance when implanted inhuman beings;
Whereas several Member States have sought to ensure that level of
safety by mandatory specifications relating both to the technical safety
features and the inspection procedures for such devices; whereas those
specifications differ from one Member State to another;
Whereas national provisions ensuring that safety level should be
harmonized in order to guarantee the free movement of active implan-table medical devices without lowering existing and justified levels of
safety in the Member States;
Whereas harmonized measures must be distinguished from measures
taken by Member States to manage the financing of public health andsickness insurance schemes directly or indirectly concerning suchdevices; whereas, therefore, such provisions do not affect the right of
Member States to implement the abovementioned measures in compli-
ance withCommunity law;
Whereas maintaining or improving the level of protection achieved in
Member States constitutes one of this Directive's essential objectives asdefined by the essential requirements;
Whereas rules governing active implantable medical devices can be
confined to those provisions needed to satisfy the essential require-
ments; whereas, because they are essential, these requirements mustreplace corresponding national provisions;
Whereas, in order to facilitate proof of conformity with these essential
requirements and to permit monitoring of that conformity, it is desir-
able to have Europe-wide harmonized standards in respect of the
prevention of risks in connection withth e design, manufacture andpackaging of active implantable medical devices; whereas such stan-dards harmonized at European level are drawn up by private-lawbodies and must retain their status as non-mandatory texts; whereas,to that end, the European Committee for Standardization (CEN) and
the European Committee for Electrotechnical Standardization (Cenelec)
are recognized as being the competent bodies to adopt harmonizedstandards in accordance withth e general guidelines for cooperationbetween the Commission and these two bodies, signed on 13November 1984; whereas, for the purposes of this Directive, a harmo-
nized standard is a technical specification (European standard or
harmonization document) adopted by either or both of these bodies, asinstructed by the Commission pursuant to the provisions of Council1990L0385 — EN — 20.11.2003 — 002.001 — 2
(1) OJ No C 14, 18. 1. 1989, p. 4.
(2) OJ No C 120, 16. 5. 1989, p. 75, and
OJ No C 149, 18. 6. 1990.
(3) OJ No C 159, 26. 6. 1989, p. 47.
▼B
Directive 83/189/EEC of 28 March1983 laying down a procedure for
the provision of information in the field of technical standards andregulations (
1), as last amended by Directive 88/182/EEC (2), and under
the abovementioned general guidelines;
Whereas evaluation procedures have to be established and accepted by
common accord between the Member States in accordance withCommunity criteria;
Whereas the specific nature of the medical sector makes it advisable to
make provision for the notified body and the manufacturer or his agentestablished in the Community to fix, by common accord, the timelimits for completion of the evaluation and verification operations for
the conformity of devices,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive shall apply to active implantable medical devices.2. For the purposes of this Directive, the following definitions shall
apply:
(a) ‘medical device’ means any instrument, apparatus, appliance, mate-
rial or other article, whether used alone or in combination, together
withany accessories or software for its proper functioning,intended by the manufacturer to be used for human beings in the:
— diagnosis, prevention, monitoring, treatment or alleviation of
disease or injury,
— investigation, replacement or modification of the anatomy or of
a physiological process,
— control of conception,
and which does not achieve its principal intended action by phar-
macological, chemical, immunological or metabolic means, butwhich may be assisted in its function by such means;
(b) ‘active medical device’ means any medical device relying for its
functioning on a source of electrical energy or any source of powerother than that directly generated by the human body or gravity;
(c) ‘active implantable medical device’ means any active medical
device which is intended to be totally or partially introduced, surgi-
cally or medically, into the human body or by medical interventioninto a natural orifice, and which is intended to remain after theprocedure;
(d) ‘custom-made device’ means any active implantable medical
device specifically made in accordance witha medical specialist's
written prescription which gives, under his responsibility, specificdesign characteristics and is intended to be used only for an indivi-dual named patient;
(e) ‘device intended for clinical investigation’ means any active
implantable medical device intended for use by a specialist doctor
when conducting investigations in an adequate human clinicalenvironment;
(f) ‘intended purpose’ means the use for which the medical device is
intended and for which it is suited according to the data supplied
by the manufacturer in the instructions;
(g) ‘putting into service’ means making available to the medical
profession for implantation;
(h) ‘placing on the market’ means the first making available in return
for payment or free of charge of a device other than a deviceintended for clinical investigation, witha view to distribution and/1990L0385 — EN — 20.11.2003 — 002.001 — 3
(1) OJ No L 109, 26. 4. 1983, p. 8.
(2) OJ No L 81, 26. 3. 1988, p. 75.▼M1
▼M1
or use on the Community market, regardless of whether it is new or
fully refurbished;
(i) ‘manufacturer’ means the natural or legal person with responsibility
for the design, manufacture, packaging and labelling of a devicebefore it is placed on the market under his own name, regardlessof whether these operations are carried out by that person himselfor on his behalf by a third party.
The obligations of this Directive 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-madeproducts and/or assigns to them their intended purpose as a devicewith a view to their being placed on the market under his own
name. This subparagraph does not apply to the person who, while
not a manufacturer within the meaning of the first subparagraph,assembles or adapts devices already on the market to their intendedpurpose for an individual patient.
3. Where an active implantable medical device is intended to admin-
ister a substance defined as a medicinal product within the meaning ofCouncil Directive 65/65/EEC (
1) of 26 January 1965 on the approxima-
tion of provisions laid down by law, regulation or administrative action
relating to proprietary medicinal products, as last amended by Directive
87/21/EEC (2), that substance shall be subject to the system of
marketing authorization provided for in that Directive.
4. Where an active implantable medical device incorporates, as an
integral part, a substance which, if used separately, may be consideredto be a medicinal product within the meaning of Article 1 of Directive65/65/EEC, that device must be evaluated and authorized in accordance
with the provisions of this Directive.
5. This Directive constitutes a specific Directive within the meaning
of Article 2 (2) of Council Directive 89/336/EEC (
3) of 3 May 1989 on
the approximation of the laws of the Member States relating to electro-magnetic compatibility.
Article 2
Member States shall take all necessary steps to ensure that the devices
referred to in Article 1 (2) (c) and (d) may be placed on the market andput into service only if they do not compromise the safety and health ofpatients, users and, where applicable, other persons when properlyimplanted, maintained and used in accordance withth eir intended
purposes.
Article 3
The active implantable medical devices referred to in Article 1 (2) (c),
(d) and (e), hereinafter referred to as ‘devices’, must satisfy the essen-
tial requirements set out in Annex 1, which shall apply to them accountbeing taken of the intended purpose of the devices concerned.
Article 4
1. Member States shall not prevent the placing on the market or the
putting into service within their territory of devices complying with theprovisions of this Directive and bearing the CE marking provided for inArticle 12 which indicate that they have been the subject of an evalua-tion of their conformity in accordance with Article 9.1990L0385 — EN — 20.11.2003 — 002.001 — 4
(1) OJ No 22, 9. 2. 1965, p. 369/65.
(2) OJ No L 15, 17. 1. 1987, p. 36.
(3) OJ No L 139, 23. 5. 1989, p. 19.▼B
▼M2
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2. Member States shall not create any obstacles to:
— devices intended for clinical investigations being made available to
specialist doctors for that purpose if they satisfy the conditions laid
down in Article 10 and in Annex 6,
— custom-made devices being placed on the market and put into
service if they satisfy the conditions laid down in Annex 6 and areaccompanied by the statement referred to in that Annex.
These devices shall not bear the ►
M2CE marking ◄.
3. At trade fairs, exhibitions, demonstrations, etc., Member States
shall not prevent the showing of devices which do not conform to thisDirective, provided that a visible sign clearly indicates that suchdevices do not conform and cannot be put into service until they havebeen made to comply by the manufacturer or his authorized representa-
tive established within the Community.
4. When a device is put into service, Member States may require the
information described in sections 13, 14 and 15 of Annex 1 to be in
their national language(s).
5. (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 whicharrangements to apply, the CE marking shall indicate conformityto the provisions only of those Directives applied by the manu-
facturer. In this case, particulars of the Directives applied, as
published in the Official Journal of the European Communities ,
must be given in the documents, notices or instructions requiredby the Directives and accompanying such devices; these docu-ments, notices or instructions shall be accessible without itbeing necessary to destroy the packaging which keeps the device
sterile.
Article 5
Member States shall presume compliance with the essential require-
ments referred to in Article 3 in respect of devices which are inconformity withth e relevant national standards adopted pursuant tothe harmonized standards the references of which have been publishedin theOfficial Journal of the European Communities ; Member States
shall publish the references of such national standards.
Article 6
1. Where a Member State or the Commission considers that the
harmonized standards referred to in Article 5 do not entirely meet theessential requirements referred to in Article 3, the Commission or theMember State concerned shall bring the matter before the Standing
Committee set up under Directive 83/189/EEC, giving the reasons
therefor. The Committee shall deliver an opinion without delay.
In the light of the opinion of the Committee, the Commission shall
inform Member States of the measures to be taken with regard to the
standards and the publication referred to in Article 5.
2. The Commission shall be assisted by a standing committee (here-
inafter referred to as ‘the Committee’).1990L0385 — EN — 20.11.2003 — 002.001 — 5
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▼M3
▼M3
The Committee may be apprised, in accordance with the procedure
referred to in this paragraph, of any matter to which the implementa-tion and practical application of this Directive give rise.
Where reference is made to this paragraph, Articles 3 and 7 of Deci-
sion 1999/468/EC (
1) shall apply, having regard to the provisions of
Article 8 thereof.
The Committee shall adopt its rules of procedure.
Article 7
1. Where a Member State finds that the devices referred to in
Article 1 (2) (c) and (d), correctly put into service and used in accor-dance with their intended purpose, may compromise the health and/or
safety of patients, users or, where applicable, other persons, it shall
take all appropriate measures to withdraw such devices from themarket or prohibit or restrict their being placed on the market or theirbeing put into service.
The Member State shall immediately inform the Commission of any
suchmeasure, indicating th e reasons for its decision and, in particular,
whether non-compliance with this Directive is due to:
(a) failure to meet the essential requirements referred to in Article 3,
where the device does not meet in full or in part the standards
referred to in Article 5;
(b) incorrect application of those standards;
(c) shortcomings in the standards themselves.
2. The Commission shall enter into consultation with the parties
concerned as soon as possible. Where, after such consultation, theCommission finds that:
— the measures are justified, it shall immediately so inform the
Member State which took the initiative and the other MemberStates; where the decision referred to in paragraph 1 is attributedto shortcomings in the standards, the Commission shall, after
consulting the parties concerned, bring the matter before the
Committee referred to in Article 6 (1) within two months if theMember State which has taken the decision intends to maintain itand shall initiate the procedures referred to in Article 6 (1),
— the measures are unjustified, it shall immediately so inform the
Member State which took the initiative and the manufacturer or
his authorized representative established within the Community.
3. Where a device which does not comply bears the ►
M2CE
marking ◄, the competent Member State shall take appropriate action
against whomsoever has affixed the mark and shall inform the
Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept
informed of the progress and outcome of this procedure.
Article 8
1. Member States shall take the necessary steps to ensure that infor-
mation brought to their knowledge regarding the incidents mentionedbelow involving a device is recorded and evaluated in a centralizedmanner:
(a) any deterioration in the characteristics and performances of a
device, as well as any inaccuracies in the instruction leaflet whichmight lead to or might have led to the death of a patient or to adeterioration in his state of health;1990L0385 — EN — 20.11.2003 — 002.001 — 6
(1) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures
for the exercise of implementing powers conferred on the Commission (OJ
L 184, 17.7.1999, p. 23).▼B
▼B
(b) any technical or medical reason resulting in withdrawal of a device
from the market by the manufacturer.
2. Member States shall, without prejudice to Article 7, forthwith
inform the Commission and the other Member States of the incidents
referred to in paragraph1 and of th e relevant measures taken or
contemplated.
Article 9
1. In the case of devices other than those which are custom-made or
intended for clinical investigations, the manufacturer must, in order toaffix the ►
M2CE marking ◄at his own choice:
(a) follow the procedure relating to the EC declaration of conformity
set out in Annex 2; or
(b) follow the procedure relating to EC type-examination set out in
Annex 3, coupled with:
(i) the procedure relating to EC verification set out in Annex 4, or
(ii) the procedure relating to the EC declaration of conformity to
type set out in Annex 5.
2. In the case of custom-made devices, the manufacturer must draw
up the declaration provided for in Annex 6 before placing each deviceon the market.
3. Where appropriate, the procedures provided for in Annexes 3, 4
and 6 may be discharged by the manufacturer's authorized representa-tive established in the Community.
4. The records and correspondence relating to the procedures
referred to in paragraphs 1, 2 and 3 shall be in an official language of
the Member State in which the said procedures will be carried out and/
or in a language acceptable to the notified body defined in Article 11.
5. During the conformity assessment procedure for a device, the
manufacturer and/or the notified body shall take account of the resultsof any assessment and verification operations which, where appro-priate, have been carried out in accordance with this Directive at an
intermediate stage of manufacture.
6. Where the conformity assessment procedure involves the inter-
vention of a notified body, the manufacturer, or his authorizedrepresentative established in the Community, may apply to a body ofhis choice within the framework of the tasks for which the body hasbeen notified.
7. The notified body may require, where duly justified, any informa-
tion 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
Annexes II and III shall be valid for a maximum of five years and
may be extended on application, made at a time agreed in the contractsigned by bothparties, for furth er periods of five years.
9. By derogation from paragraphs 1 and 2 the competent authorities
may authorize, on duly justified request, the placing on the market andputting into service, within the territory of the Member Stateconcerned, of individual devices for which the procedures referred to
in paragraphs 1 and 2 have not been carried out and the use of which
is in the interest of protection of health.
Article 9a
1. Where a Member State considers that the conformity of a device
or family of devices should be established, by way of derogation fromthe provisions of Article 9, by applying solely one of the given proce-dures chosen from among those referred to in Article 9, it shall submita duly substantiated request to the Commission and ask it to take thenecessary measures. These measures shall be adopted in accordance1990L0385 — EN — 20.11.2003 — 002.001 — 7
▼M1
▼M1
withth e procedure referred to in Article 7 (2) of Directive 93/42/
EEC (1).
2. The Commission shall inform the Member States of the measures
taken and, where appropriate, publish the relevant parts of thesemeasures in the Official Journal of the European Communities .
Article 10
1. In the case of devices intended for clinical investigations, the
manufacturer or his authorized representative established in theCommunity shall, at least 60 days before the commencement of theinvestigations, submit the statement referred to in Annex 6 to thecompetent authorities of the Member State in which the investigations
are to be conducted.
2. The manufacturer may commence the relevant clinical investiga-
tions at the end of a period of 60 days after notification, unless thecompetent authorities have notified him within that period of a decision
to the contrary, based on considerations of public health or public
order.
Member States may however authorize manufacturers to start the clin-
ical investigations in question before the expiry of the 60-day period,provided that the Ethical Committee concerned has delivered a favour-able opinion withrespect to th e investigation programme in question.
2a. The authorization referred to in the second subparagraph of para-
graph 2 may be subject to approval by the competent authority.
3. The Member States shall, if necessary, take the appropriate steps
to ensure public health and order.
Article 11
1. Member States shall notify the Commission and the other
Member State of the bodies which they have appointed to carry outthe procedures referred to in Article 9 together with the specific taskswhich these bodies have been appointed to carry out and the identifica-
tion numbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the European
Communities a list of the notified bodies and their identification
numbers and the tasks for which they have been notified. The Commis-
sion shall ensure that this list is kept up to date.
2. Member States shall apply the minimum criteria, set out in Annex
8, for the designation of bodies. Bodies that satisfy the criteria fixed bythe relevant harmonized standards shall be presumed to satisfy the rele-vant minimum criteria.
3. A Member State that has notified a body shall withdraw that noti-
fication if it finds that the body no longer meets the criteria referred toin paragraph 2. It shall immediately inform the other Member Statesand the Commission thereof.
4. The notified body and the manufacturer or his agent established
in the Community shall fix, by common accord, the time limits forcompletion of the evaluation and verification operations referred to inAnnexes 2 to 5.
Article 12
1. Devices other than those which are custom made or intended for
clinical investigations considered to meet the essential requirements1990L0385 — EN — 20.11.2003 — 002.001 — 8
(1) OJ L 169, 12. 7. 1993, p. 1.▼B
▼M1
▼B
▼M2
▼B
▼B
referred to in Article 3 must bear the ►M2CE marking ◄of confor-
mity.
2. The ►M2CE marking ◄of conformity, as shown in Annex 9,
must appear in a visible, legible and indelible form on the sterile pack
and, where appropriate, on the sales packaging, if any, and on theinstruction leaflet.
It must be followed by the identification number of the notified body
responsible for implementation of the procedures set out in Annexes2, 4 and 5.
3. The affixing of markings on the devices which are likely to
deceive third parties as to the meaning and form of the CE markingshall be prohibited. 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 hereby reduced.
Article 13
Without prejudice to Article 7
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his authorized representativeestablished within the Community shall be obliged to end the
infringement under conditions imposed by the Member State;
(b) where non-compliance continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on the
market of the device in question or to ensure that it is withdrawn
from the market in accordance with the procedures laid down inArticle 7.
Article 14
Any decision taken pursuant to this Directive and resulting in the
refusal of or restrictions on the placing on the market and/or putting
into service of a device shall state the exact grounds on which it isbased. Such a decision shall be notified without delay to the partyconcerned, who shall at the same time be informed of the remediesavailable to him under the laws in force in the Member State in ques-
tion and of the time limits to which such remedies are subject.
In the event of a decision as referred to in the previous paragraph the
manufacturer, or his authorized representative established in theCommunity, shall have an opportunity to put forward his viewpoint in
advance, unless suchconsultation is not possible because of th e
urgency of the measures to be taken.
Article 15
Member States shall ensure that all the parties involved in the applica-
tion of this Directive are bound to observe confidentiality with regard
to all information obtained in carrying out their tasks. This does not
affect the obligations of Member States and notified bodies with regardto mutual information and the dissemination of warnings.
Article 16
1. Before 1 July 1992, Member States shall adopt and publish the
laws, regulations and administrative provisions necessary in order to
comply with this Directive. They shall forthwith inform the Commis-
sion thereof.
They shall apply such provisions from 1 January 1993.2. Member States shall communicate to the Commission the texts of
the provisions of national law which they adopt in the field covered bythis Directive.1990L0385 — EN — 20.11.2003 — 002.001 — 9
▼M2
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▼M1
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3. Member States shall, for the period up to 31 December 1994,
permit the placing on the market and putting into service of devicescomplying withnational rules in force in th eir territory on 31
December 1992.
Article 17
This Directive is addressed to the Member States.1990L0385 — EN — 20.11.2003 — 002.001 — 10
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ANNEX 1
ESSENTIALREQUIREMENTS
I. GENERAL REQUIREMENTS
1. The devices must be designed and manufactured in such a way that, when
implanted 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 applic-
able, to other persons.
2. The devices must achieve the performances intended by the manufacturer,
viz. be designed and manufactured in such a way that they are suitable for
one or more of the functions referred to in Article 1 (2) (a) as specified by
him.
3. The characteristics and performances referred to in sections 1 and 2 must
not be adversely affected to such a degree that the clinical condition and
safety of the patients or, as appropriate, of other persons are compromised
during the lifetime of the device anticipated by the manufacturer, where
the device is subjected to stresses which may occur during normal condi-
tions 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.
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
6. 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.
7. 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 condi-
tions stipulated by the manufacturer, remain so until the packaging is
removed and they are implanted.
8. Devices must be designed and manufactured in sucha way as to remove
or minimize as far as possible:
— the risk of physical injury in connection with their physical, including
dimensional, features,
— risks connected withth e use of energy sources withparticular refer-
ence, where electricity is used, to insulation, leakage currents and
overheating of the devices,
— risks connected withreasonably foreseeable environmental conditions
suchas magnetic fields, external electrical influences, electrostatic
discharge, pressure or variations in pressure and acceleration,
— risks connected withmedical treatment, in particular th ose resulting
from the use of defibrillators or high-frequency surgical equipment,
— risks connected withionizing radiation from radioactive substances
included in the device, in compliance with the protection requirements
laid down in Directive 80/836/Euratom (1), as amended by Directives
84/467/Euratom (2) and 84/466/Euratom (3),
— risks which may arise where maintenance and calibration are impos-
sible, including:
— excessive increase of leakage currents,
— ageing of the materials used,
— excess heat generated by the device,— decreased accuracy of any measuring or control mechanism.1990L0385 — EN — 20.11.2003 — 002.001 — 11
(1) OJ No L 246, 17. 9. 1980, p. 1.
(2) OJ No L 265, 5. 10. 1984, p. 4.
(3) OJ No L 265, 5. 10. 1984, p. 1.
▼B
9. The devices must be designed and manufactured in such a way as to guar-
antee the characteristics and performances referred to in I. ‘General
requirements’, withparticular attention being paid to:
— the choice of materials used, particularly as regards toxicity aspects,
— mutual compatibility between the materials used and biological
tissues, cells and body fluids, account being taken of the anticipated
use of the device,
— compatibility of the devices with the substances they are intended to
administer,
— the quality of the connections, particularly in respect of safety,
— the reliability of the source of energy,
— if appropriate, that they are leakproof,— proper functioning of the programming and control systems, including
software.
10. Where a device incorporates, as an integral part, a substance which, when
used separately, is likely to be considered to be a medicinal product as
defined in Article 1 of Directive 65/65/EEC, and whose action in combi-
nation with the device may result in its bioavailability, the safety, quality
and usefulness of the substance, account being taken of the purpose of the
device, must be verified by analogy with the appropriate methods speci-
fied in Directive 75/318/EEC (
1), as last amended by Directive 89/341/
EEC (2).
11. The devices and, if appropriate, their component parts must be identified
to allow any necessary measure to be taken following the discovery of a
potential risk in connection with the devices and their component parts.
12. Devices must bear a code by which they and their manufacturer can be
unequivocably identified (particularly withregard to th e type of device
and year of manufacture); it must be possible to read this code, if neces-
sary, without the need for a surgical operation.
13. When a device or its accessories bear instructions required for the opera-
tion of the device or indicate operating or adjustment parameters, by
means of a visual system, suchinformation must be understandable to
the user and, as appropriate, the patient.
14. Every device must bear, legibly and indelibly, the following particulars,
where appropriate in the form of generally recognized symbols:
14.1. On the sterile pack:
— the method of sterilization,
— an indication permitting this packaging to be recognized as such,
— the name and address of the manufacturer,
— a description of the device,
— if the device is intended for clinical investigations, the words: ‘exclu-
sively for clinical investigations’,
— if the device is custom-made, the words ‘custom-made device’,
— a declaration that the implantable device is in a sterile condition,
— the month and year of manufacture,
— an indication of the time limit for implanting a device safely.
14.2. On the sales packaging:
— the name and address of the manufacturer,
— a description of the device,
— the purpose of the device,
— the relevant characteristics for its use,
— if the device is intended for clinical investigations, the words: ‘exclu-
sively for clinical investigations’,
— if the device is custom-made, the words: ‘custom-made device’,
— a declaration that the implantable device is in a sterile condition,— the month and year of manufacture,
— an indication of the time limit for implanting a device safely,
— the conditions for transporting and staring the device.
15. When placed on the market, each device must be accompanied by instruc-
tions for use giving the following particulars:
— the year of authorization to affix the CE mark,1990L0385 — EN — 20.11.2003 — 002.001 — 12
(1) OJ No L 147, 9. 6. 1975, p. 1.
(2) OJ No L 142, 25. 5. 1989, p. 11.
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— the details referred to in 14,1 and 14.2, with the exception of those
referred to in the eighth and ninth indents,
— the performances referred to in section 2 and any undesirable side
effects,
— information allowing the physician to select a suitable device and the
corresponding software and accessories,
— 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,
— information allowing, if appropriate, certain risks in connection with
implantation of the device to be avoided,
— information regarding the risks of reciprocal interference (*) in
connection with the presence of the device during specific investiga-
tions or treatment,
— the necessary instructions in the event of the sterile pack being
damaged and, where appropriate, details of appropriate methods of
resterilization,
— an indication, if appropriate, that a device can be reused only if it is
reconditioned under the responsibility of the manufacturer to comply
withth e essential requirements.
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:
— information allowing the lifetime of the energy source to be estab-
lished,
— precautions to be taken should changes occur in the device's perfor-
mance,
— precautions to be taken as regards exposure, in reasonably foreseeable
environmental conditions, to magnetic fields, external electrical influ-
ences, electrostatic discharge, pressure or variations in pressure,
acceleration, etc.,
— adequate information regarding the medicinal products which the
device in question is designed to administer.
16. Confirmation that the device satisfies the requirements in respect of char-
acteristics and performances, as referred to in I. ‘General requirements’, in
normal conditions of use, and the evaluation of the side effects or undesir-
able effects must be based on clinical data established in accordance with
Annex 7.1990L0385 — EN — 20.11.2003 — 002.001 — 13
(*) ‘Risks of reciprocal interference’ means adverse effects on the device caused by
instruments present at the time of investigations or treatment, and vice versa.
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ANNEX 2
ECDECLARATIONOFCONFORMITY
(Completequalityassurancesystem)
1. The manufacturer shall apply the quality system approved for the design,
manufacture and final inspection of the products concerned as specified in
sections 3 and 4 and shall be subject to EC surveillance as specified in
section 5.
2. The declaration of conformity is the procedure by means of which the
manufacturer who satisfies the obligations of section 1 ensures and declaresthat the products concerned meet the provisions of this Directive which
apply to them.
The manufacturer or his authorized representative established within the
Community shall affix the CE marking in accordance with Article 12 and
shall draw up a written declaration of conformity.
This declaration shall cover one or more identified examples of the product
and shall be kept by the manufacturer or his authorized representative
established within the Community.
The CE marking shall be accompanied by the identification number of the
notified body responsible.
3.Qualitysystem
3.1. The manufacturer shall make an application for evaluation of his quality
system to a notified body.
The application shall include:
— all the appropriate items of information for the category of products
manufacture of which is envisaged,
— the quality-system documentation,— an undertaking to fulfil the obligations arising from the quality system
as approved,
— an undertaking to maintain the approved quality system in such a way
that it remains adequate and efficacious,
— an undertaking by the manufacturer to institute and keep up-dated a
post-marketing surveillance system. The undertaking shall include an
obligation for the manufacturer to notify the competent authorities of
the following incidents immediately on learning of them:
(i) 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;
(ii) any technical or medical reason resulting in withdrawal of a device
from the market by the manufacturer.
3.2. The application of the quality system must ensure that the products
conform to the provisions of this Directive 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 suchas quality programmes, quality plans, quality
manuals and quality records.
It shall include in particular an adequate description of:
(a) the manufacturer's quality objectives;
(b) the organization of the business and in particular:
— the organizational structures, the responsibilities of the managerial
staff and their organizational authority where quality of design and
manufacture of the products is concerned,
— 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;1990L0385 — EN — 20.11.2003 — 002.001 — 14
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(c) the procedures for monitoring and verifying the design of the products
and in particular:
— 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 stan-
dards referred to in Article 5 are not applied in full,
— the techniques of control and verification of the design, the
processes and systematic actions which will be used when the
products are being designed;
(d) the techniques of control and of quality assurance at the manufacturing
stage and in particular:
— the processes and procedures which will be used, particularly as
regards sterilization, purchasing and the relevant documents,
— product-identification procedures drawn up and kept up to date
from drawings, specifications or other relevant documents at every
stage of manufacture;
(e) 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.
3.3. Without prejudice to Article 13 of this Directive, the notified body shall
effect an audit of the quality system to determine whether it meets the
requirements referred to in 3.2. It shall presume conformity with these
requirements for the quality systems which use the corresponding harmo-
nized 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.
3.4. 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 3.2; it shall notify the manufacturer of its decision. This deci-
sion shall contain the conclusions of the control and a reasoned evaluation.
4.Examinationofthedesignoftheproduct
4.1. In addition to the obligations incumbent on him under section 3, the manu-
facturer 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 3.1.
4.2. The application shall describe the design, manufacture, and performances
of the product in question and shall include the necessary particulars which
make it possible to evaluate whether it complies with the requirements of
this Directive.
It shall include inter alia :
— the design specifications, including the standards which have been
applied,
— the necessary proof of their appropriations, in particular where the stan-
dards referred to in Article 5 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,
— a statement as to whether or not the device incorporates, as an integral
part, a substance as referred to in section 10 of Annex 1, whose action
in combination with the device may result in its bioavailability, together
withdata on th e relevant trials conducted,
— the clinical data referred to in Annex 7,— the draft instruction leaflet.
4.3. The notified body shall examine the application and, where the product
complies with the relevant provisions of this Directive, shall issue the
applicant withan EC design examination certificate. Th e notified body
may require the application to be supplemented by further tests or proof
so that compliance with the requirements of the Directive may be evalu-
ated. The certificate shall contain the conclusions of the examination, the
conditions of its validity, the data needed for identification of the approved1990L0385 — EN — 20.11.2003 — 002.001 — 15
▼B
design and, where appropriate, a description of the intended use of the
product.
4.4. 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 essen-
tial requirements of this Directive 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
5.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the
obligations arising from the approved quality system.
5.2. The manufacturer shall authorize the notified body to carry out all neces-
sary inspections and shall supply it with all appropriate information, in
particular:
— the quality-system documentation,
— the data stipulated in the part of the quality system relating to design,
suchas th e results of analyses, calculations, tests, etc.,
— the data stipulated in the part of the quality system relating to manufac-
ture, suchas reports concerning inspections, tests, standardizations/
calibrations and the qualifications of the staff concerned, etc.
5.3. 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 evalua-
tion report.
5.4. In addition, the notified body may make unannounced visits to the manu-
facturer, and shall supply him with an inspection report.
6.Administrativeprovisions
6.1. For at least five years from last date of manufacture of the product, the
manufacturer shall keep available for the national authorities:
— the declaration of conformity,
— the documentation referred to in the second indent of section 3.1,— the amendments referred to in section 3.4,
— the documentation referred to in section 4.2,
— the decisions and reports of the notified body referred to in sections 3.4,
4.3, 5.3 and 5.4.
6.2. On request, the notified body shall make available to the other notified
bodies and the competent authority all relevant information on approvals
of quality systems issued, refused or withdrawn.
6.3. Where neither the manufacturer nor his authorized representative are estab-
lished in the Community, the task of keeping available for the authorities
the technical documentation referred to in Article 4 (2) shall fall to the
person responsible for placing the appliance on the Community market.1990L0385 — EN — 20.11.2003 — 002.001 — 16
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ANNEX 3
ECTYPE-EXAMINATION
1. EC type-examination is the procedure whereby a notified body observes
and certifies that a representative sample of the production envisaged satis-
fies the relevant provisions of this Directive.
2. The application for EC type-examination shall be made by the manufac-
turer, or by his authorized representative established in the Community, to
a notified body.
The application shall include:
— the name and address of the manufacturer and the name and address of
the authorized representative if the application is made by the latter,
— a written declaration specifying that an application has not been made
to any other notified body,
— the documentation described in section 3 needed to allow an evaluation
to be made of the conformity of a representative sample of the produc-
tion in question, hereinafter referred to as ‘type’, with the requirements
of this Directive.
The applicant shall make a ‘type’ available to the notified body. The noti-
fied 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 general description of the type,
— design drawings, methods of manufacture envisaged, in particular as
regards sterilization, and diagrams of parts, sub-assemblies, circuits,
etc.,
— the descriptions and explanations necessary for the understanding of the
abovementioned drawings and diagrams and of the operation of the
product,
— a list of the standards referred to in Article 5, applied in full or in part,
and a description of the solutions adopted to satisfy the essential
requirements where the standards referred to in Article 5 have not
been applied,
— the results of design calculations, investigations and technical tests
carried out, etc.,
— a statement as to whether or not the device incorporates, as an integral
part, a substance as referred to in section 10 of Annex 1, whose action
in combination with the device may result in its bioavailability, together
withdata on th e relevant trials conducted,
— the clinical data referred to in Annex 7,— the draft instruction leaflet.
4. The notified body shall:
4.1. 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 Article 5, as well as the items
for which the design is not based on the relevant provisions of the said
standards;
4.2. 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 this Directive where the standards
referred to in Article 5 have not been applied;
4.3. 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;
4.4. 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 this Directive, the notified body
shall issue an EC type-examination certificate to the applicant. The certifi-
cate 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 certifi-
cate and a copy shall be kept by the notified body.1990L0385 — EN — 20.11.2003 — 002.001 — 17
▼B
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
suchmodifications may affect conformity withth e 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.Administrativeprovisions
7.1. 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.
7.2. Other notified bodies may obtain a copy of the EC type-examination certi-
ficates 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.
7.3. The manufacturer or his authorized representative shall keep with the tech-
nical documentation a copy of the EC type-examination certificates and the
supplements to them for a period of at least five years from the manufac-
ture of the last appliance.
7.4. Where neither the manufacturer nor his authorized representative are estab-
lished in the Community, the task of keeping the technical documentation
available for the authorities shall fall to the person responsible for placing
the appliance concerned on the Community market.1990L0385 — EN — 20.11.2003 — 002.001 — 18
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ANNEX 4
ECVERIFICATION
1. EC verification is the procedure whereby the manufacturer or his author-
ized representative established within the Community ensures and declares
that the products subject to the provisions of section 3 are in conformity
with the type as described in the EC type-examination certification and
satisfy the requirements of this Directive that apply to them.
2. The manufacturer or his authorized representative established within the
Community shall take all measures necessary in order that the manufac-
turing process ensures conformity of the products to the type as described
in the EC type-examination certification and to the requirements of this
Directive that apply to them. The manufacturer or his authorized represen-
tative established within the Community 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 sterilization,
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 this Directive.
4. The manufacturer shall undertake to institute and keep updated a post-
marketing surveillance system. This undertaking shall include the obliga-
tion on the part of the manufacturer to notify the competent authorities of
the following events immediately on learning of them:
(i) 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;
(ii) 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 this
Directive by examination and testing of products on a statistical basis, as
specified in section 6. The manufacturer must authorize the notified body
to evaluate the efficiency of the measures taken pursuant to section 3, by
audit where appropriate.
6.Statisticalverification
6.1. 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.
6.2. A random sample shall be taken from each batch. Products in a sample
shall be individually examined and appropriate tests, as set out in the stan-
dard(s) referred to in Article 5, 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.
6.3. Statistical control of products shall be based on attributes, entailing a
sampling system with the following characteristics:
— a level of quality corresponding to a probability of acceptance of 95 %,
witha non-conformity percentage of between 0,29 and 1 %,
— a limit quality corresponding to a probability of acceptance of 5 %,
witha percentage of non-conformity of between 3 and 7 %.
6.4. Where batches are accepted, the notified body shall affix, or cause to be
affixed, its identification number to eachproduct 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 verifica-
tion.
The manufacturer may, under the responsibility of the notified body, affix
the latter's identification number during the manufacturing process.
6.5. The manufacturer or his authorized representative shall ensure that he is
able to supply the notified body's certificates of conformity on request.1990L0385 — EN — 20.11.2003 — 002.001 — 19
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ANNEX 5
ECDECLARATIONOFCONFORMITYTOTYPE
(Assuranceofproductionquality)
1. The manufacturer shall apply the quality system approved for the manufac-
ture and shall conduct the final inspection of the products concerned as
specified in 3; he shall be subject to the surveillance referred to in section
4.
2. This declaration of conformity is the procedural element whereby the
manufacturer who satisfies the obligations of section 1 guarantees and
declares that the products concerned conform to the type described in the
EC type-examination certificate and meet the provisions of the Directive
which apply to them.
The manufacturer or his authorized representative established within the
Community shall affix the CE marking in accordance with Article 12 and
draw up a written declaration of conformity. This declaration shall cover
one or more identified specimens of the product and shall be kept by the
manufacturer. The CE marking shall be accompanied by the identification
number of the notified body responsible.
3.Qualitysystem
3.1. The manufacturer shall make an application for evaluation of his quality
system to a notified body.
The application shall include:
— all appropriate information concerning the products which it is intended
to manufacture,
— the quality-system documentation,— an undertaking to fulfil the obligations arising from the quality system
as approved,
— an undertaking to maintain the approved quality system in such a way
that it remains adequate and efficacious,
— where appropriate, the technical documentation relating to the approved
type and a copy of the EC type-examination certificate,
— an undertaking by the manufacturer to institute and keep up-dated a
post-marketing surveillance system. The undertaking shall include an
obligation for the manufacturer to notify the competent authorities of
the following incidents immediately on learning of them:
(i) 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;
(ii) any technical or medical reason resulting in withdrawal of a device
from the market by the manufacturer.
3.2. 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 suchas quality programmes, quality plans, quality
manuals and quality records.
It shall include in particular an adequate description of:
(a) the manufacturer's quality objectives;
(b) the organization of the business and in particular:
— the organizational structures, the responsibilities of the managerial
staff and their organizational authority where manufacture of the
products is concerned,
— the methods of monitoring the efficient operation of the quality
system and in particular its ability to achieve the desired quality
►
C1 ◄of the products, including control of
products which do not conform;1990L0385 — EN — 20.11.2003 — 002.001 — 20
▼M2
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(c) the techniques of control and of quality assurance at the manufacturing
stage and in particular:
— the processes and procedures which will be used, particularly as
regards sterilization, purchasing and the relevant documents,
— product identification procedures drawn up and kept up-to-date
from drawings, specifications or other relevant documents at every
stage of manufacture;
(d) 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.
3.3. Without prejudice to Article 13, the notified body shall effect an audit of
the quality system to determine whether it meets the requirements referred
to in 3.2. It shall presume conformity with these requirements for the
quality systems which use the corresponding harmonized 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 themanufacturer'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.
3.4. 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 3.2; it shall notify the manufacturer of its decision. This deci-
sion shall contain the conclusions of the control and a reasoned evaluation.
4.Surveillance
4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the
obligations which arise from the approved quality system.
4.2. The manufacturer shall authorize the notified body to carry out all neces-
sary inspections and shall supply it with all appropriate information, in
particular:
— the quality-system documentation,
— the data stipulated in the part of the quality system relating to manufac-
ture, suchas reports concerning inspections, tests, standardizations/
calibrations and the qualifications of the staff concerned, etc.
4.3. 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 evalua-
tion report.
4.4. In addition, the notified body may make unannounced visits to the manu-
facturer, and shall supply him with an inspection report.
5. The notified body shall communicate to the other notified bodies all rele-
vant information concerning approvals of quality systems issued, refused or
withdrawn.1990L0385 — EN — 20.11.2003 — 002.001 — 21
▼B
ANNEX 6
STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL
PURPOSES
1. The manufacturer or his authorized representative established within the
Community shall draw up for custom-made devices or for devices intended
for clinical investigations the statement comprising the elements stipulated
in section 2.
2. The statement shall comprise the following information:2.1. For custom-made devices:
— data allowing the device in question to be identified,
— a statement affirming that the device is intended for exclusive use by a
particular patient, together with his name,
— the name of the doctor who drew up the prescription and, if applicable,
the name of the clinic concerned,
— the particular features of the device as described by the medical
prescription concerned,
— a statement affirming that the device complies with the essential
requirements given in Annex 1 and, where applicable, indicating which
essential requirements have not been wholly met, together with the
grounds.
2.2. For devices intended for clinical investigations covered in Annex 7:
— data allowing the devices in question to be identified,
— an investigation plan giving in particular the purpose, scope and number
of the devices concerned,
— the name of the doctor and of the institution responsible for the inves-
tigations,
— the place, date of commencement and duration scheduled for the inves-
tigations,
— 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 precau-
tion has been taken to protect the health and safety of the patient.
3. The manufacturer shall undertake to keep available for the competent
national authorities:
3.1. For custom-made devices, documentation enabling the design, manufacture
and performances of the product, including the expected performances, to
be understood, so as to allow conformity with the requirement of this
Directive to be assessed.
The manufacturer shall take all necessary measures to see that the manu-
facturing process ensures that the products manufactured conform to the
documentation referred to in the first paragraph.
3.2. For devices intended for clinical investigations, the documentation shall
also contain:
— a general description of the product,
— design drawings, manufacturing methods, in particular as regards steri-
lization, and diagrams of parts, sub-assemblies, circuits, etc.,
— the descriptions and explanations necessary for the understanding of the
said drawings and diagrams and of the operation of the product,
— a list of the standards laid down in Article 5, applied in full or in part,
and a description of the solutions adopted to satisfy the essential
requirements of the Directive where the standards in Article 5 have
not been applied,
— the results of the design calculations, checks and technical tests carried
out, etc.
The manufacturer shall take all necessary measures to see that the manu-
facturing process ensures that the products manufactured conform to the
documentation referred to in 3.1 and in the first paragraph of this section.
The manufacturer may authorize the evaluation, by audit where necessary,
of the effectiveness of these measures.1990L0385 — EN — 20.11.2003 — 002.001 — 22
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ANNEX 7
CLINICALEVALUATION
1.General provisions
1.1. Adequacy of the clinical data presented, as referred to in section 4.2 of
Annex 2, and in section 3 of Annex 3, shall be based, account being
taken as appropriate of the relevant harmonized standards, on either:
1.1.1. a collation of currently available relevant scientific literature covering the
intended use of the device and the techniques therefor, as well as, if
appropriate, a written report making a critical assessment of thiscollation; or
1.1.2. the results of all clinical investigations made, including those carried out
in accordance withsection 2.
1.2. All data must remain confidential unless it is deemed essential that they
be divulged.
2.Clinicalinvestigation
2.1.Purpose
The purpose of clinical investigation is to:
— verify that, under normal conditions of use, the performances of the
device comply withth ose indicated in section 2 of Annex 1,
— determine any undesirable side effects, under normal conditions of
use, and assess whether they are acceptable risks having regard to
the intended performance of the device.
2.2.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.
2.3.Methods
2.3.1. 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.
2.3.2. The procedures utilized to perform the investigations shall be appropriate
to the device under examination.
2.3.3. Clinical investigations shall be performed in circumstances equivalent to
those which would be found in normal conditions of use of the device.
2.3.4. All appropriate features, including those involving the safety and perfor-
mances of the device, and its effects on the patients, shall be examined.
2.3.5. All adverse events shall be fully recorded.2.3.6. The investigations shall be performed under the responsibility of an
appropriately qualified medical specialist, in an appropriate environment.
The medical specialist shall have access to the technical data regarding
the device.
2.3.7. The written report, signed by the responsible medical specialist, shall
comprise a critical evaluation of all the data collected during the clinical
investigation.1990L0385 — EN — 20.11.2003 — 002.001 — 23
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ANNEX 8
MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPEC-
TIONBODIESTOBENOTIFIED
1. 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 authorized representative
of any of those parties. They may not become directly involved in the design,
construction, marketing or maintenance of the devices, nor represent theparties engaged in these activities. This does not preclude the possibility of
exchanges of technical information between the manufacturer and the body.
2. The body and its staff must carry out the evaluation and verification opera-
tions with the highest degree of professional integrity and technical
competence and must be free from all pressures and inducements, particu-
larly financial, which might influence their judgement or the results of the
inspection, especially from persons or groups of persons withan interest in
the results of verifications.
3. The body must be able to carry out all the tasks in one of Annexes 2 to 5
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 parti-
cular, it must have at its disposal the necessary staff and possess the
necessary facilities to enable it to perform properly the technical and admin-
istrative tasks connected withevaluation and verification; it must also h ave
access to the equipment necessary for the verifications required.
4. The staff responsible for control operations must have:
— sound vocational training covering all the evaluation and verification
operations for which the body has been designated,
— satisfactory knowledge of the requirements of the controls they carry out
and adequate experience of suchoperations,
— the ability required to draw up the certificates, records and reports to
demonstrate that the controls have been carried out.
5. 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
suchcontrols.
6. The body must take out liability insurance unless liability is assumed by the
State in accordance withnational law, or th e Member State itself is directly
responsible for controls.
7. The staff of the body are bound to observe professional secrecy with regard
to all information gained in carrying out their tasks (except vis-à-vis the
competent administrative authorities of the State in which their activities are
carried out) under this Directive or any provision of national law giving
effect to it.1990L0385 — EN — 20.11.2003 — 002.001 — 24
▼M2
ANNEX IX
CECONFORMITYMARKING
— The CE conformity marking shall consist of the initials ‘CE’ taking the
following form:
— 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 5 mm.
This minimum dimension may be waived for small-scale devices.1990L0385 — EN — 20.11.2003 — 002.001 — 25