1990L0385 — EN — 02.08.1993 — 001.001 — 1
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►B COUNCIL DIRECTIVE
of 20June 1990
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:
OfficialJournal
No page date
►M1 CouncilDirective 93/42/EEC of 14 June 1993 L 169 1 12.7.1993
►M2 CouncilDirective 93/68/EEC of 22 Jul y 1993 L 220 1 30.8.1993
Corrected by:
►C1 Corrigendum, OJ L 7, 1.11.1994, p. 20 (90/385)
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COUNCIL DIRECTIVE
of 20June 1990
on the approximation of the laws of the Member States relating to
active implantable medical 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 proposalfrom the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and SocialCommittee (3),
Whereas in each Member State active implantable medical devices must
give patients, users and other persons a high level of protection andachieve the intended level of performance when implanted in humanbeings;
Whereas severalMember States have sought to ensure that l evelof
safety by mandatory specifications relating both to the technical safetyfeatures and the inspection procedures for such devices; whereas thosespecifications differ from one Member State to another;
Whereas nationalprovisions ensuring that safety l evelshoul d be
harmonized in order to guarantee the free movement of active implant-able medical devices without lowering existing and justified levels ofsafety 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 ofMember States to implement the abovementioned measures in compli-ance with Community law;
Whereas maintaining or improving the level of protection achieved in
Member States constitutes one of this Directive’s essentialobjectives asdefined by the essentialrequirements;
Whereas rules governing active implantable medical devices can be
confined to those provisions needed to satisfy the essentialrequire-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 desirableto have Europe-wide harmonized standards in respect of the preventionof risks in connection with the design, manufacture and packaging ofactive implantable medical devices; whereas such standards harmonizedat European level are drawn up by private-law bodies and must retaintheir status as non-mandatory texts; whereas, to that end, the EuropeanCommittee for Standardization (CEN) and the European Committee forElectrotechnical Standardization (Cenelec) are recognized as being thecompetent bodies to adopt harmonized standards in accordance with thegeneralguidel ines for cooperation between the Commission and thesetwo bodies, signed on 13 November 1984; whereas, for the purposes ofthis Directive, a harmonized standard is a technicalspecification (Euro-pean standard or harmonization document) adopted by either or both ofthese bodies, as instructed by the Commission pursuant to the provi-sions of CouncilDirective 83/189/EEC of 28 March 1983 l aying down
(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.
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a procedure for the provision of information in the field of technical
standards and regulations (1), as last amended by Directive 88/
182/EEC (2), and under the abovementioned generalguidel ines;
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 medicalsector makes it advisabl e to
make provision for the notified body and the manufacturer or his agentestablished in the Community to fix, by common accord, the time limitsfor completion of the evaluation and verification operations for theconformity 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) ‘medicaldevice' means any instrument, apparatus, appl iance,
material or other article, whether used alone or in combination,together with any 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,
— controlof conception,
and which does not achieve its principalintended action by pharma-
cological, chemical, immunological or metabolic means, but whichmay be assisted in its function by such means;
(b) ‘active medicaldevice' means any medicaldevice rel ying 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 naturalorifice, and which is intended to remain after theprocedure;
(d) ‘custom-made device' means any active implantable medical device
specifically made in accordance with a medical specialist’s writtenprescription which gives, under his responsibility, specific designcharacteristics and is intended to be used only for an individualnamed patient;
(e) ‘device intended for clinical investigation' means any active
implantable medical device intended for use by a specialist doctorwhen conducting investigations in an adequate human clinicalenvironment;
(f) ‘intended purpose' means the use for which the medicaldevice is
intended and for which it is suited according to the data supplied bythe manufacturer in the instructions;
(g) ‘putting into service' means making available to the medical profes-
sion for implantation;
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(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, with a view to distribution and/or
(1) OJ No L 109, 26. 4. 1983, p. 8.
(2) OJ No L 81, 26. 3. 1988, p. 75.
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use on the Community market, regardless of whether it is new or
fully refurbished;
(i) ‘manufacturer' means the naturalor l egalperson with responsibil ity
for the design, manufacture, packaging and labelling of a devicebefore it is placed on the market under his own name, regardless ofwhether these operations are carried out by that person himself oron 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 ownname. This subparagraph does not apply to the person who, whilenot a manufacturer within the meaning of the first subparagraph,assembles or adapts devices already on the market to their intendedpurpose for an individualpatient.
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3. Where an active implantable medical device is intended to admin-
ister a substance defined as a medicinalproduct within the meaning ofCouncilDirective 65/65/EEC (
1) of 26 January 1965 on the approx-
imation of provisions laid down by law, regulation or administrativeaction relating to proprietary medicinal products, as last amended byDirective 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
integralpart, a substance which, if used separatel y, may be consideredto be a medicinalproduct within the meaning of Articl e 1 of Directive65/65/EEC, that device must be evaluated and authorized in accordancewith 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 with their intendedpurposes.
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 essentialrequirements set out in Annex 1, which shall apply to them, accountbeing taken of the intended purpose of the devices concerned.
Article 4
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1. Member States shall not prevent the placing on the market or theputting 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 evalu-ation of their conformity in accordance with Article 9.
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2. Member States shall not create any obstacles to:
(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.
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— devices intended for clinical investigations being made available to
specialist doctors for that purpose if they satisfy the conditions laiddown 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 such devicesdo not conform and cannot be put into service untilthey have beenmade to comply by the manufacturer or his authorized representativeestablished 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 intheir nationall anguage(s).
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5. (a) Where the devices are subject to other Directives concerning
other aspects and which also provide for the affixing of the CEmarking, the latter shall indicate that the devices are alsopresumed to conform to the provisions of the other Directives.
(b) However, where one or more of these Directives allow the
manufacturer, during a transitionalperiod, 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, aspublished 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 it beingnecessary to destroy the packaging which keeps the devicesterile.
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Article 5
Member States shall presume compliance with the essential require-
ments referred to in Article 3 in respect of devices which are inconformity with the relevant national standards adopted pursuant to theharmonized standards the references of which have been published intheOfficial 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 theessentialrequirements referred to in Articl e 3, the Commission or theMember State concerned shall bring the matter before the StandingCommittee set up under Directive 83/189/EEC, giving the reasonstherefor. 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 thestandards and the publication referred to in Article 5.
2. A Standing Committee, hereinafter referred to as the ‘Committee',
shall be set up, composed of the representatives of the Member Statesand chaired by the representative of the Commission.
The Committee shall draw up its rules of procedure.Any matter relating to the implementation and practical application of
this Directive may be brought before the Committee, in accordance withthe procedure set out below.
The representative of the Commission shall submit to the Committee a
draft of the measures to be taken. The Committee shall deliver its
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opinion according to the urgency of the matter, if necessary by taking avote.
The opinion shall be recorded in the minutes; in addition, each Member
State shall have the right to ask to have its position recorded in theminutes.
The Commission shall take the utmost account of the opinion delivered
by the Committee. It shall inform the Committee of the manner inwhich its opinion has been taken into account.
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 accordance withtheir intended purpose, may compromise the health and/or safety ofpatients, users or, where applicable, other persons, it shall take allappropriate measures to withdraw such devices from the market orprohibit or restrict their being placed on the market or their being putinto service.
The Member State shall immediately inform the Commission of any
such measure, indicating the 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 standardsreferred 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 attributed toshortcomings in the standards, the Commission shall, afterconsulting the parties concerned, bring the matter before theCommittee 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 hisauthorized 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 Commis-sion 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;
(b) any technicalor medicalreason resul ting in withdrawalof 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
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referred to in paragraph 1 and of the relevant measures taken or contem-plated.
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 repres-entative 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 theMember State in which the said procedures will be carried out and/or ina language acceptable to the notified body defined in Article 11.
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5. During the conformity assessment procedure for a device, themanufacturer and/or the notified body shall take account of the resultsof any assessment and verification operations which, where appropriate,have been carried out in accordance with this Directive at an inter-mediate stage of manufacture.
6. Where the conformity assessment procedure involves the interven-
tion of a notified body, the manufacturer, or his authorized repres-entative established in the Community, may apply to a body of hischoice within the framework of the tasks for which the body has beennotified.
7. The notified body may require, where duly justified, any informa-
tion or data which is necessary for establishing and maintaining theattestation 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 maybe extended on application, made at a time agreed in the contract signedby both parties, for further 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 State concerned,of individualdevices for which the procedures referred to in paragraphs1 and 2 have not been carried out and the use of which is in the interestof 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 proced-ures chosen from among those referred to in Article 9, it shall submit aduly substantiated request to the Commission and ask it to take thenecessary measures. These measures shall be adopted in accordance
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with the 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 these meas-ures in the Official Journal of the European Communities .
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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 investigationsare 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 decisionto the contrary, based on considerations of public health or public order.
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Member States may however authorize manufacturers to start the clin-icalinvestigations in question before the expiry of the 60-day period,provided that the EthicalCommittee concerned has del ivered a favour-able opinion with respect to the investigation programme in question.
2a. The authorization referred to in the second subparagraph of para-
graph 2 may be subject to approvalby the competent authority.
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3. The Member States shall, if necessary, take the appropriate stepsto ensure public health and order.
Article 11
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1. Member States shall notify the Commission and the other MemberState of the bodies which they have appointed to carry out the proced-ures referred to in Article 9 together with the specific tasks which thesebodies have been appointed to carry out and the identification numbersassigned 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.
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2. Member States shall apply the minimum criteria, set out in Annex8, for the designation of bodies. Bodies that satisfy the criteria fixed bythe relevant harmonized standards shall be presumed to satisfy therelevant minimum criteria.
3. A Member State that has notified a body shall withdraw that
notification if it finds that the body no longer meets the criteria referredto in 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.
(1) OJ L 169, 12. 7. 1993, p. 1.
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Article 12
1. Devices other than those which are custom made or intended for
clinical investigations considered to meet the essential requirementsreferred to in Article 3 must bear the ►
M2CE marking ◄of
conformity.
2. The ►M2CE marking ◄of conformity, as shown in Annex 9,
must appear in a visible, legible and indelible form on the sterile packand, where appropriate, on the sales packaging, if any, and on theinstruction leaflet.
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It must be followed by the identification number of the notified bodyresponsible for implementation of the procedures set out in Annexes 2,4 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 packagingor to the instruction leaflet accompanying the device provided that thevisibility 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 theinfringement 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 themarket of the device in question or to ensure that it is withdrawnfrom the market in accordance with the procedures laid down inArticle 7.
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Article 14
Any decision taken pursuant to this Directive and resulting in the
refusalof or restrictions on the pl acing on the market and/or putting intoservice of a device shall state the exact grounds on which it is based.Such a decision shall be notified without delay to the party concerned,who shall at the same time be informed of the remedies available to himunder the laws in force in the Member State in question and of the timelimits to which such remedies are subject.
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In the event of a decision as referred to in the previous paragraph themanufacturer, or his authorized representative established in theCommunity, shall have an opportunity to put forward his viewpoint inadvance, unless such consultation is not possible because of the urgencyof the measures to be taken.
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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 toall information obtained in carrying out their tasks. This does not affectthe obligations of Member States and notified bodies with regard tomutualinformation 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 tocomply with this Directive. They shall forthwith inform the Commis-sion thereof.
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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.
3. Member States shall, for the period up to 31 December 1994,
permit the placing on the market and putting into service of devicescomplying with national rules in force in their territory on 31 December1992.
Article 17
This Directive is addressed to the Member States.
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ANNEX1
ESSENTIAL REQUIREMENTS
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 usedoes not compromise the clinical condition or the safety of patients. Theymust not present any risk to the persons implanting them or, whereapplicable, 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 forone or more of the functions referred to in Article 1 (2) (a) as specified byhim.
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 andsafety of the patients or, as appropriate, of other persons are compromisedduring the lifetime of the device anticipated by the manufacturer, wherethe device is subjected to stresses which may occur during normalcondi-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 thestorage and transport conditions laid down by the manufacturer (tempera-ture, 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 thegenerally 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 aresterile when placed on the market and, in the storage and transport condi-tions stipulated by the manufacturer, remain so until the packaging isremoved and they are implanted.
8. Devices must be designed and manufactured in such a 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 with the use of energy sources with particular refer-
ence, where electricity is used, to insulation, leakage currents andoverheating of the devices
— risks connected with reasonably foreseeable environmental conditions
such as magnetic fields, external electrical influences, electrostaticdischarge, pressure or variations in pressure and acceleration,
— risks connected with medical treatment, in particular those resulting
from the use of defibrillators or high-frequency surgical equipment,
— risks connected with ionizing radiation from radioactive substances
included in the device, in compliance with the protection requirementslaid 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 controlmechanism.
9. The devices must be designed and manufactured in such a way as to
guarantee the characteristics and performances referred to in I. ‘Generalrequirements', with particular attention being paid to:
(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.
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— 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 thedevice,
— 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 controlsystems, incl uding
software.
10. Where a device incorporates, as an integralpart, a substance which, when
used separately, is likely to be considered to be a medicinal product asdefined in Article 1 of Directive 65/65/EEC, and whose action in combina-tion with the device may result in its bioavailability, the safety, quality andusefulness of the substance, account being taken of the purpose of thedevice, must be verified by analogy with the appropriate methods specifiedin 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 apotentialrisk 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 with regard to the type of device andyear of manufacture); it must be possible to read this code, if necessary,without the need for a surgicaloperation.
13. When a device or its accessories bear instructions required for the opera-
tion of the device or indicate operating or adjustment parameters, by meansof a visualsystem, such information must be understandabl e to the userand, 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,— the details referred to in 14,1 and 14.2, with the exception of those
referred to in the eighth and ninth indents,
(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 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 accessoriesand software correctly, as well as information on the nature, scope andtimes for operating controls and trials and, where appropriate, mainte-nance measures,
— information allowing, if appropriate, certain risks in connection with
implantation of the device to be avoided,
— information regarding the risks of reciprocalinterference (*) in connec-
tion with the presence of the device during specific investigations ortreatment,
— the necessary instructions in the event of the sterile pack being
damaged and, where appropriate, details of appropriate methods ofresterilization,
— an indication, if appropriate, that a device can be reused only if it is
reconditioned under the responsibility of the manufacturer to complywith the essentialrequirements.
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
performance,
— 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, accel-eration, etc.,
— adequate information regarding the medicinalproducts 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. ‘Generalrequirements', innormalconditions of use, and the eval uation of the side effects or undesir-able effects must be based on clinical data established in accordance withAnnex 7.
(*) ‘Risks of reciprocalinterference' means adverse effects on the device caused by
instruments present at the time of investigations or treatment, and vice versa.
1990L0385 — EN — 02.08.1993 — 001.001 — 14
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ANNEX2
EC DECLARATION OF CONFORMITY
(Complete quality assurance system)
1. The manufacturer shall apply the quality system approved for the design,
manufacture and finalinspection of the products concerned as specified insections 3 and 4 and shall be subject to EC surveillance as specified insection 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 whichapply to them.
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The manufacturer or his authorized representative established within theCommunity shall affix the CE marking in accordance with Article 12 andshall 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 representativeestablished within the Community.
The CE marking shall be accompanied by the identification number of the
notified body responsible.
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3.Quality system
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 anobligation for the manufacturer to notify the competent authorities of thefollowing 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 leadto or have led to the death of a patient or a deterioration in his stateof health;
(ii) any technicalor medicalreason resul ting in withdrawalof 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, fromdesign to finalcontrol s.
All the elements, requirements and provisions adopted by the manufacturer
for his quality system shall be documented in a systematic and orderlymanner in the form of written policies and procedures. This quality-systemdocumentation must make possible a uniform interpretation of the qualitypolicies and procedures such as quality programmes, quality plans, qualitymanuals 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 organizationalstructures, the responsibil ities of the managerial
staff and their organizationalauthority where qual ity of design andmanufacture 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 ofthe design and of the products, including control of products whichdo not conform;
(c) the procedures for monitoring and verifying the design of the products
and in particular:
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— the design specifications, including the standards which will be
applied and a description of the solutions adopted to fulfil theessentialrequirements which appl y to the products when the stan-dards referred to in Article 5 are not applied in full,
— the techniques of controland verification of the design, the
processes and systematic actions which will be used when theproducts are being designed;
(d) the techniques of controland of qual ity 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 stageof 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 thetest 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 therequirements referred to in 3.2. It shall presume conformity with theserequirements for the quality systems which use the corresponding harmon-ized 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’spremises.
The decision shal lbe notified to the manufacturer after the finalinspection.
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 requirementsreferred to in 3. 2; it shall notify the manufacturer of its decision. Thisdecision shall contain the conclusions of the control and a reasoned evalu-ation.
4.Examination of the design of the product
4.1. In addition to the obligations incumbent on him under section 3, the
manufacturer shall make an application for examination of the designdossier relating to the product which he plans to manufacture and whichfalls 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 whichmake it possible to evaluate whether it complies with the requirements ofthis 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
standards referred to in Article 5 have not been applied in full. Thisproof must include the results of the appropriate tests carried out by themanufacturer 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 actionin combination with the device may result in its bioavailability, togetherwith data on the 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 theapplicant with an EC design examination certificate. The notified body mayrequire the application to be supplemented by further tests or proof so thatcompliance with the requirements of the Directive may be evaluated. Thecertificate shall contain the conclusions of the examination, the conditionsof its validity, the data needed for identification of the approved 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
1990L0385 — EN — 02.08.1993 — 001.001 — 16
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approvalfrom the notified body which issued the EC design examination
certificate where such modifications may affect conformity with the essen-tialrequirements of this Directive or the conditions prescribed for the use ofthe product. This supplementary approval shall be given in the form of anaddendum 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 necessary
inspections and shall supply it with all appropriate information, in partic-ular:
— the quality-system documentation,— the data stipulated in the part of the quality system relating to design,
such as the results of analyses, calculations, tests, etc.,
— the data stipulated in the part of the quality system relating to manufac-
ture, such as reports concerning inspections, tests, standardizations/cali-brations 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 theapproved quality system, and shall supply the manufacturer with an evalu-ation report.
5.4. In addition, the notified body may make unannounced visits to the manufac-
turer, and shall supply him with an inspection report.
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6.Administrative provisions
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 ofquality 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 authoritiesthe technical documentation referred to in Article 4 (2) shall fall to theperson responsible for placing the appliance on the Community market.
1990L0385 — EN — 02.08.1993 — 001.001 — 17
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ANNEX3
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 satisfiesthe 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 anotified 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 requirementsof this Directive.
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 shallcontain the following items in particular:
— a generaldescription 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 theproduct,
— 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 essentialrequirements where the standards referred to in Article 5 have not beenapplied,
— 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 actionin combination with the device may result in its bioavailability, togetherwith data on the 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 theitems which have been designed in accordance with the applicable provi-sions of the standards referred to in Article 5, as well as the items for whichthe 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 manufacturersatisfy the essentialrequirements of this Directive where the standardsreferred 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 therelevant 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 conclusionsof the control, the conditions under which the certificate is valid and theinformation 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.
1990L0385 — EN — 02.08.1993 — 001.001 — 18
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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 approvalfrom
the notified body which issued the EC type-examination certificate wheresuch modifications may affect conformity with the essentialrequirements orwith the conditions of use specified for the product. This new approvalshal lbe issued, where appropriate, in the form of a supplement to the initial ECtype-examination certificate.
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7.Administrative provisions
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 bemade available to the other notified bodies when a reasoned application ismade and after the manufacturer has been informed.
7.3. The manufacturer or his authorized representative shall keep with the tech-
nicaldocumentation a copy of the EC type-examination certificates and thesupplements to them for a period of at least five years from the manufactureof 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 documentationavailable for the authorities shall fall to the person responsible for placingthe appliance concerned on the Community market.
1990L0385 — EN — 02.08.1993 — 001.001 — 19
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ANNEX4
EC VERIFICATION
1. EC verification is the procedure whereby the manufacturer or his authorized
representative established within the Community ensures and declares thatthe products subject to the provisions of section 3 are in conformity with thetype as described in the EC type-examination certification and satisfy therequirements 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 inthe EC type-examination certification and to the requirements of thisDirective that apply to them. The manufacturer or his authorized repres-entative established within the Community shall affix the CE marking toeach 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 implementedto ensure uniformity of production and conformity of the products with thetype as described in the EC type-examination certificate as well as with therelevant requirements of this Directive.
4. The manufacturer shall undertake to institute and keep updated a post-
marketing surveillance system. This undertaking shall include the obligationon the part of the manufacturer to notify the competent authorities of thefollowing 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 tothe death of a patient or deterioration in his state of health;
(ii) any technicalor medicalreason resul ting in the withdrawalof 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 thisDirective by examination and testing of products on a statisticalbasis, asspecified in section 6. The manufacturer must authorize the notified body toevaluate the efficiency of the measures taken pursuant to section 3, by auditwhere appropriate.
6.Statistical verification
6.1. Manufacturers shall present the products manufactured in the form of
uniform batches and shall take all necessary measures in order that themanufacturing 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 standard(s)referred to in Article 5, or equivalent tests shall be carried out to verify theirconformity to the type as described in the EC type-examination certificateand thereby determine whether a batch is to be accepted or rejected.
6.3. Statisticalcontrolof products shal lbe based on attributes, entail ing a
sampling system with the following characteristics:
— a level of quality corresponding to a probability of acceptance of 95 %,
with a non-conformity percentage of between 0,29 and 1 %,
— a limit quality corresponding to a probability of acceptance of 5 %,
with a 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 each product and draw up a writtencertificate of conformity relating to the tests carried out. All products in thebatch may be placed on the market except for those products from thesample 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
1990L0385 — EN — 02.08.1993 — 001.001 — 20
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rejection of batches the notified body may suspend the statisticalverifica-
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 — 02.08.1993 — 001.001 — 21
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ANNEX5
EC DECLARATION OF CONFORMITY TO TYPE
(Assurance of production quality)
1. The manufacturer shall apply the quality system approved for the manufac-
ture and shal lconduct the finalinspection of the products concerned asspecified 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 manu-
facturer who satisfies the obligations of section 1 guarantees and declaresthat the products concerned conform to the type described in the ECtype-examination certificate and meet the provisions of the Directive whichapply to them.
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The manufacturer or his authorized representative established within theCommunity shall affix the CE marking in accordance with Article 12 anddraw up a written declaration of conformity. This declaration shall coverone or more identified specimens of the product and shall be kept by themanufacturer. The CE marking shall be accompanied by the identificationnumber of the notified body responsible.
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3.Quality system
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 technicaldocumentation rel ating 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 anobligation for the manufacturer to notify the competent authorities of thefollowing 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 leadto or have led to the death of a patient or a deterioration in his stateof health;
(ii) any technicalor medicalreason resul ting in withdrawalof 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 orderlymanner in the form of written policies and procedures. This quality-systemdocumentation must make possible a uniform interpretation of the qualitypolicies and procedures such as quality programmes, quality plans, qualitymanuals 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 organizationalstructures, the responsibil ities of the managerial
staff and their organizationalauthority where manufacture of theproducts is concerned,
— the methods of monitoring the efficient operation of the quality
system and in particular its ability to achieve the desired quality ofthe products, including control of products which do not conform;
(c) the techniques of controland of qual ity 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,
1990L0385 — EN — 02.08.1993 — 001.001 — 22
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— product identification procedures drawn up and kept up-to-date
from drawings, specifications or other relevant documents at everystage 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 thetest 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 in3.2. It shall presume conformity with these requirements for the qualitysystems 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 the manufacturer’spremises.
The decision shal lbe notified to the manufacturer after the finalinspection.
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 requirementsreferred to in 3.2; it shall notify the manufacturer of its decision. Thisdecision shall contain the conclusions of the control and a reasoned evalu-ation.
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 necessary
inspections and shall supply it with all appropriate information, in partic-ular:
— the quality-system documentation,— the data stipulated in the part of the quality system relating to manufac-
ture, such as reports concerning inspections, tests, standardizations/cali-brations 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 theapproved quality system, and shall supply the manufacturer with an evalu-ation report.
4.4. In addition, the notified body may make unannounced visits to the manufac-
turer, 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 orwithdrawn.
1990L0385 — EN — 02.08.1993 — 001.001 — 23
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ANNEX6
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 intendedfor clinical investigations the statement comprising the elements stipulatedin 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 require-
ments given in Annex 1 and, where applicable, indicating which essen-tial 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 investi-
gations,
— the place, date of commencement and duration scheduled for the investi-
gations,
— a statement affirming that the device in question complies with the
essentialrequirements apart from the aspects constituting the object ofthe 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
nationalauthorities:
3.1. For custom-made devices, documentation enabling the design, manufacture
and performances of the product, including the expected performances, tobe understood, so as to allow conformity with the requirement of thisDirective to be assessed.
The manufacturer shall take all necessary measures to see that the manufac-
turing process ensures that the products manufactured conform to the docu-mentation referred to in the first paragraph.
3.2. For devices intended for clinical investigations, the documentation shall also
contain:
— a generaldescription of the product,— design drawings, manufacturing methods, in particular as regards sterili-
zation, 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 essentialrequirements of the Directive where the standards in Article 5 have notbeen 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 manufac-
turing process ensures that the products manufactured conform to the docu-mentation 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.
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ANNEX7
CLINICAL EVALUATION
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 takenas 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, ifappropriate, a written report making a critical assessment of this collation;or
1.1.2. the results of all clinical investigations made, including those carried out
in accordance with section 2.
1.2. All data must remain confidential unless it is deemed essential that they be
divulged.
2.Clinical investigation
2.1.Purpose
The purpose of clinical investigation is to:
— verify that, under normalconditions of use, the performances of the
device comply with those 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 theintended 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 inTokyo, Japan, in 1975 and the 35th World Medical Assembly in Venice,Italy, in 1983. It is mandatory that all measures relating to the protectionof human subjects are carried out in the spirit of the Declaration ofHelsinki. This includes every step in the clinical investigation from firstconsideration of need and justification of the study to publication ofresults.
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 orrefute the manufacturer’s claims for the device; the investigations shallinclude an adequate number of observations to guarantee the scientificvalidity 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 appro-
priately qualified medical specialist, in an appropriate environment.
The medicalspecial ist shal lhave access to the technicaldata 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 clinicalinvestigation.
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ANNEX8
MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPEC-
TION BODIES TO BE NOTIFIED
1. The body, its director and the staff responsible for carrying out the evaluation
and verification operations shall not be the designer, manufacturer, supplier orinstaller of devices which they control, nor the authorized representative ofany 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 ofexchanges of technicalinformation 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 professionalintegrity and technicalcompet-ence and must be free from all pressures and inducements, particularly finan-cial, which might influence their judgement or the results of the inspection,especially from persons or groups of persons with an interest in the results ofverifications.
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 thosetasks are carried out by the body itself or under its responsibility. In partic-ular, it must have at its disposal the necessary staff and possess the necessaryfacilities to enable it to perform properly the technical and administrativetasks connected with evaluation and verification; it must also have access tothe equipment necessary for the verifications required.
4. The staff responsible for control operations must have:
— sound vocationaltraining covering al lthe eval uation 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 such operations,
— 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 ofsuch controls.
6. The body must take out liability insurance unless liability is assumed by the
State in accordance with national law, or the Member State itself is directlyresponsible for controls.
7. The staff of the body are bound to observe professionalsecrecy 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 arecarried out) under this Directive or any provision of nationall aw giving effectto it.
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ANNEXIX
CE CONFORMITY MARKING
— 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
verticaldimension, which may not be l ess than 5 mm.
This minimum dimension may be waived for small-scale devices.