1993L0042 — EN — 20.11.2003 — 004.001 — 1
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►B COUNCILDIRECTIVE93/42/EEC
of14June1993
concerningmedicaldevices
(OJ L 169, 12.7.1993, p. 1)
Amended by:
Official Journal
No page date
►M1Directive 98/79/EC of the European Parliament and of the Council of 27
October 1998L 331 1 7.12.1998
►M2Directive 2000/70/EC of the European Parliament and of the Council of
16 November 2000L 313 22 13.12.2000
►M3Directive 2001/104/EC of the European Parliament and of the Council of
7 December 2001L 6 50 10.1.2002
►M4Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003L 284 1 31.10.2003
▼B
COUNCILDIRECTIVE93/42/EEC
of14June1993
concerningmedicaldevices
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 with the European Parliament(2),
Having regard to the opinion of the Economic and Social
Committee(3),
Whereas measures should be adopted in the context of the internal
market; whereas the internal market is an area without internal frontiers
in which the free movement of goods, persons, services and capital isensured;
Whereas the content and scope of the laws, regulations and administra-
tive provisions in force in the Member States with regard to the safety,health protection and performance characteristics of medical devicesare different; whereas the certification and inspection procedures for
such devices differ from one Member State to another; whereas such
disparities constitute barriers to trade within the Community;
Whereas the national provisions for the safety and health protection of
patients, users and, where appropriate, other persons, with regard to theuse of medical devices should be harmonized in order to guarantee thefree movement of such devices within the internal market;
Whereas the harmonized provisions must be distinguished from the
measures adopted by the Member States to manage the funding ofpublic health and sickness insurance schemes relating directly or indir-ectly to such devices; whereas, therefore, the provisions do not affect
the ability of the Member States to implement the abovementioned
measures provided Community law is complied with;
Whereas medical devices should provide patients, users and third
parties with a high level of protection and attain the performance levelsattributed to them by the manufacturer; whereas, therefore, the mainte-nance or improvement of the level of protection attained in theMember States is one of the essential objectives of this Directive;
Whereas certain medical devices are intended to administer medicinal
products within the meaning of Council Directive 65/65/EEC of 26
January 1965 on the approximation of provisions laid down by law,
regulation or administrative action relating to proprietary medicinalproducts(
4); whereas, in such cases, the placing on the market of the
medical device as a general rule is governed by the present Directiveand the placing on the market of the medicinal product is governedby Directive 65/65/EEC; whereas if, however, such a device is placed
on the market in such a way that the device and the medicinal product
form a single integral unit which is intended exclusively for use in thegiven combination and which is not reusable, that single-unit productshall be governed by Directive 65/65/EEC; whereas a distinction mustbe drawn between the abovementioned devices and medical devices
incorporating, inter alia , substances which, if used separately, may be
considered to be a medicinal substance within the meaning of Directive65/65/EEC; whereas in such cases, if the substances incorporated in themedical devices are liable to act upon the body with action ancillary tothat of the device, the placing of the devices on the market is governedby this Directive; whereas, in this context, the safety, quality and1993L0042 — EN — 20.11.2003 — 004.001 — 2
(1) OJ No C 237, 12. 9. 1991 and OJ No C 251, 28. 9. 1992, p. 40.
(2) OJ No C 150, 31. 5. 1993 and OJ No C 176, 28. 6. 1993.
(3) OJ No C 79, 30. 3. 1992, p. 1.
(4) OJ No 22, 9. 6. 1965, p. 369/65. Directive as last amended by Directive 92/
27/EEC (OJ No L 113, 30. 4. 1992, p. 8).
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usefulness of the substances must be verified by analogy with the
appropriate methods specified in Council Directive 75/318/EEC of 20May 1975 on the approximation of the laws of the Member States
relating to analytical, pharmaco-toxicological and clinical standards
and protocols in respect of the testing of proprietary medicinalproducts(
1);
Whereas the essential requirements and other requirements set out in
the Annexes to this Directive, including any reference to ‘minimizing’or ‘reducing’ risk must be interpreted and applied in such a way as totake account of technology and practice existing at the time of designand of technical and economical considerations compatible with a high
level of protection of health and safety;
Whereas, in accordance with the principles set out in the Council reso-
lution of 7 May 1985 concerning a new approach to technical
harmonization and standardization(
2), rules regarding the design and
manufacture of medical devices must be confined to the provisionsrequired to meet the essential requirements; whereas, because they areessential, such requirements should replace the corresponding nationalprovisions; whereas the essential requirements should be applied with
discretion to take account of the technological level existing at the
time of design and of technical and economic considerations compa-tible with a high level of protection of health and safety;
Whereas Council Directive 90/385/EEC of 20 June 1990 on the
approximation of the laws of the Member States relating to activeimplantable medical devices(
3) is the first case of application of the
new approach to the field of medical devices; whereas in the interestof uniform Community rules applicable to all medical devices, this
Directive is based largely on the provisions of Directive 90/385/EEC;
whereas for the same reasons Directive 90/385/EEC must be amendedto insert the general provisions laid down in this Directive;
Whereas the electromagnetic compatibility aspects form an integral
part of the safety of medical devices; whereas this Directive shouldcontain specific rules on this subject with regard to Council Directive89/336/EEC of 3 May 1989 on the approximation of the laws of theMember States relating to electromagnetic compatibility(
4);
Whereas this Directive should include requirements regarding the
design and manufacture of devices emitting ionizing radiation; whereas
this Directive does not affect the authorization required by Council
Directive 80/836/Euratom of 15 July 1980 amending the Directiveslaying down the basic safety standards for the health protection of thegeneral public and workers against the dangers of ionizing radiation(
5),
nor application of Council Directive 84/466/Euratom of 3 September1984 laying down basic measures for the radiation protection of
persons undergoing medical examination or treatment(
6); whereas
Council Directive 89/391/EEC of 12 June 1989 on the introduction ofmeasures to encourage improvements in the safety and health ofworkers at work(
7) and the specific directives on the same subject
should continue to apply;
Whereas, in order to demonstrate conformity with the essential require-
ments and to enable conformity to be verified, it is desirable to haveharmonized European standards to protect against the risks associated
with the design, manufacture and packaging of medical devices;
whereas such harmonized European standards are drawn up byprivate-law bodies and should retain their status as non-mandatory1993L0042 — EN — 20.11.2003 — 004.001 — 3
(1) OJ No L 147, 9. 6. 1975, p. 1. Directive as last amended by Directive 91/
507/EEC (OJ No L 270, 26. 9. 1991, p. 32).
(2) OJ No C 136, 4. 6. 1985, p. 1.
(3) OJ No L 189, 20. 7. 1990, p. 17.
(4) OJ No L 139, 23. 5. 1989, p. 19. Directive as last amended by Directive 92/
31/EEC (OJ No L 126, 12. 5. 1992, p. 11).
(5) OJ No L 246, 17. 9. 1980, p. 1. Directive as last amended by Directive 84/
467/Euratom (OJ No L 265, 5. 10. 1984, p. 4).
(6) OJ No L 265, 5. 10. 1984, p. 1.
(7) OJ No L 183, 29. 6. 1989, p. 1.
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texts; whereas, to this end, the European Committee for Standardiza-
tion (CEN) and the European Committee for ElectrotechnicalStandardization (Cenelec) are recognized as the competent bodies for
the adoption of harmonized standards in accordance with the general
guidelines on cooperation between the Commission and these twobodies signed on 13 November 1984;
Whereas, for the purpose of this Directive, a harmonized standard is a
technical specification (European standard or harmonization document)
adopted, on a mandate from the Commission, by either or both of thesebodies in accordance with Council Directive 83/189/EEC of 28 March1983 laying down a procedure for the provision of information in thefield of technical standards and regulations(
1), and pursuant to the
abovementioned general guidelines; whereas with regard to possible
amendment of the harmonized standards, the Commission should beassisted by the Committee set upp ursuant to Directive 83/189/EEC;whereas the measures to be taken must be defined in line with proce-dure I, as laid down in Council Decision 87/373/EEC(
2); whereas, for
specific fields, what already exists in the form of European Pharmaco-
poeiamonographs should be incorporated within the framework of this
Directive; whereas, therefore, several European Pharmacopoeia mono-
graphs may be considered equal to the abovementioned harmonizedstandards;
Whereas, in Decision 90/683/EEC of 13 December 1990 concerning
the modules for the various phases of the conformity assessment proce-dures which are intended to be used in the technical harmonizationdirectives(
3), the Council has laid down harmonized conformity assess-
ment procedures; whereas the application of these modules to medicaldevices enables the responsibility of manufacturers and notified bodies
to be determined during conformity assessment procedures on the basis
of the type of devices concerned; whereas the details added to thesemodules are justified by the nature of the verification required formedical devices;
Whereas it is necessary, essentially for the purpose of the conformity
assessment procedures, to group the devices into four product classes;whereas the classification rules are based on the vulnerability of thehuman body taking account of the potential risks associated with thetechnical design and manufacture of the devices; whereas the confor-
mity assessment procedures for Class I devices can be carried out, as
a general rule, under the sole responsibility of the manufacturers inview of the low level of vulnerability associated with these products;whereas, for Class IIa devices, the intervention of a notified bodyshould be compulsory at the production stage; whereas, for devicesfalling within Classes IIb and III which constitute a high risk potential,
inspection by a notified body is required with regard to the design and
manufacture of the devices; whereas Class III is set aside for the mostcritical devices for which explicit prior authorization with regard toconformity is required for them to be placed on the market;
Whereas in cases where the conformity of the devices can be assessed
under the responsibility of the manufacturer the competent authoritiesmust be able, particularly in emergencies, to contact a person respon-sible for placing the device on the market and established in theCommunity, whether the manufacturer or another person establishedin the Community and designated by the manufacturer for the purpose;
Whereas medical devices should, as a general rule, bear the CE mark
to indicate their conformity with the provisions of this Directive toenable them to move freely within the Community and to be put intoservice in accordance with their intended purpose;1993L0042 — EN — 20.11.2003 — 004.001 — 4
(1) OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by Commission
Decision 92/400/EEC (OJ No L 221, 6. 8. 1992, p. 55).
(2) OJ No L 197, 18. 7. 1987, p. 33.
(3) OJ No L 147, 9. 6. 1975, p. 1. Directive as last amended by Directive 91/
507/EEC (OJ No L 270, 26. 9. 1991, p. 32).
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Whereas, in the fight against AIDS and in the light of the conclusions
of the Council adopted on 16 May 1989 regarding future activities onAIDS prevention and control at Community level(
1), medical devices
used for protection against the HIV virus must afford a high level of
protection; whereas the design and manufacture of such productsshould be verified by a notified body;
Whereas the classification rules generally enable medical devices to be
appropriately classified; whereas, in view of the diverse nature of the
devices and technological progress in this field, steps must be taken to
include amongst the implementing powers conferred on the Commis-sion the decisions to be taken with regard to the proper classificationor reclassification of the devices or, where appropriate, the adjustmentof the classification rules themselves; whereas since these issues are
closely connected with the protection of health, it is appropriate that
these decisions should come under procedure IIIa, as provided for inDirective 87/373/EEC;
Whereas the confirmation of complicance with the essential require-
ments may mean that clinical investigations have to be carried outunder the responsibility of the manufacturer; whereas, for the purpose
of carrying out the clinical investigations, appropriate means have to be
specified for the protection of public health and public order;
Whereas the protection of health and the associated controls may be
made more effective by means of medical device vigilance systemswhich are integrated at Community level;
Whereas this Directive covers the medical devices referred to in
Council Directive 76/764/EEC of 27 July 1976 on the approximationof the laws of the Member States on clinical mercury-in-glass,maximum reading thermometers(
2); whereas the abovementioned
Directive must therefore be repealed; whereas for the same reasonsCouncil Directive 84/539/EEC on 17 September 1984 on the approxi-
mation of the laws of the Member States relating to electro-medical
equipment used in human or veterinary medicine(
3) must be amended,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Definitions,scope
1. This Directive shall apply to medical devices and their acces-
sories. For the purposes of this Directive, accessories shall be treatedas medical devices in their own right. Both medical devices and acces-sories shall hereinafter be termed 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,including the software necessary for its proper application intendedby the manufacturer to be used for human beings for the purposeof:
— diagnosis, prevention, monitoring, treatment or alleviation of
disease,
— diagnosis, monitoring, treatment, alleviation of or compensation
for an injury or handicap,
— investigation, replacement or modification of the anatomy or of
a physiological process,
— control of conception,1993L0042 — EN — 20.11.2003 — 004.001 — 5
(1) OJ No C 185, 22. 7. 1989, p. 8.
(2) OJ No L 262, 27. 9. 1976, p. 139. Directive as last amended by Directive
84/414/EEC (OJ No L 228, 25. 8. 1984, p. 25).
(3) OJ No L 300, 19. 11. 1984, p. 179. Directive as amended by the Act of
Accession of Spain and Portugal.
▼B
and which does not achieve its principal intended action in or on
the human body by pharmacological, immunological or metabolicmeans, but which may be assisted in its function by such means;
(b) ‘accessory’ means an article which whilst not being a device is
intended specifically by its manufacturer to be used together with
a device to enable it to be used in accordance with the use of the
device intended by the manufacturer of the device;
(c) ‘in vitro diagnostic medical device’ means any medical device
which is a reagent, reagent product, calibrator, control material,kit, instrument, apparatus, equipment or system, whether used alone
or in combination, intended by the manufacturer to be used invitro
for the examination of specimens, including blood and tissue dona-tions,
derived from the human body, solely or principally for the purpose
of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or— to determine the safety and compatibility with potential recipi-
ents, or
— to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic
medical devices. ‘Specimen receptacles’ are those devices, whethervacuum-type or not, specifically intended by their manufacturers
for the primary containment and preservation of specimens derived
from the human body for the purpose of in vitrodiagnostic exam-
ination.
Products for general laboratory use are not in vitro diagnostic
medical devices unless such products, in view of their characteris-tics, are specifically intended by their manufacturer to be used forin vitrodiagnostic examination;
(d) ‘custom-made device’ means any device specifically made in
accordance with a duly qualified medical practitioner's writtenprescription which gives, under his responsibility, specific designcharacteristics and is intended for the sole use of a particularpatient.
The abovementioned prescription may also be made out by any
other person authorized by virtue of his professional qualificationsto do so.
Mass-produced devices which need to be adapted to meet the
specific requirements of the medical practitioner or any other
professional user are not considered to be custom-made devices;
(e) ‘device intended for clinical investigation’ means any device
intended for use by a duly qualified medical practitioner when
conducting investigations as referred to in Section 2.1 of Annex X
in an adequate human clinical environment.
For the purpose of conducting clinical investigation, any other
person who, by virtue of his professional qualifications, is author-ized to carry out such investigation shall be accepted as equivalentto a duly qualified medical practitioner;
(f) ‘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 himself
or 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 ownname. This subparagraph does not apply to the person who, whilenot a manufacturer within the meaning of the first subparagraph,1993L0042 — EN — 20.11.2003 — 004.001 — 6
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assembles or adapts devices already on the market to their intended
purpose for an individual patient;
(g) ‘intended purpose’ means the use for which the device is intended
according to the data supplied by the manufacturer on the labelling,in the instructions and/or in promotional materials;
(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 use on the Community market, regardless of whether it is new orfully refurbished;
(i) ‘putting into service’ means the stage at which a device has been
made available to the final user as being ready for use on the
Community market for the first time for its intended purpose;
(j) ‘authorised representative’ means any natural or legal person estab-
lished in the Community who, explicitly designated by the
manufacturer, acts and may be addressed by authorities and bodies
in the Community instead of the manufacturer with regard to thelatter's obligations under this Directive.
3. Where a device is intended to administer a medicinal product
within the meaning of Article 1 of Directive 65/65/EEC, that deviceshall be governed by the present Directive, without prejudice to theprovisions of Directive 65/65/EEC with regard to the medicinal
product.
If, however, such a device is placed on the market in such a way that
the device and the medicinal product form a single integral productwhich is intended exclusively for use in the given combination andwhich is not reusable, that single product shall be governed by Direc-
tive 65/65/EEC. The relevant essential requirements of Annex I to the
present Directive shall apply as far as safety and performance relateddevice features are concerned.
4. Where a device incorporates, as an integral part, a substance
which, if used separately, may be considered to be a medicinal productwithin the meaning of Article 1 of Directive 65/65/EEC and which is
liable to act upon the body with action ancillary to that of the device,
that device must be assessed and authorized in accordance with thisDirective.
4 a. Where a device incorporates, as an integral part, a substance
which, if used separately, may be considered to be a medicinal product
constituent or a medicinal product derived from human blood or humanplasma within the meaning of Article 1 of Directive 89/381/EEC(
1) and
which is liable to act upon the human body with action ancillary to thatof the device, hereinafter referred to as a ‘human blood derivative’, thatdevice must be assessed and authorised in accordance with this Direc-
tive.
5. This Directive does not apply to:
(a)in vitrodiagnostic devices;
(b) active implantable devices covered by Directive 90/385/EEC;
(c) medicinal products covered by Directive 65/65/EEC, including
medicinal products derived from blood as covered by Directive89/381/EEC;1993L0042 — EN — 20.11.2003 — 004.001 — 7
(1) Council Directive 89/381/EEC of 14 June 1989 extending the scope of
Directives 65/65/EEC and 75/319/EEC on the approximation of provisions
laid down by law, regulation or administrative action relating to proprietary
medicinal products and laying down special provisions for medicinal
products derived from human blood or human plasma (OJ L 181,
28.6.1989, p. 44).▼M1
▼B
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(d) cosmetic products covered by Directive 76/768/EEC(1);
(e) human blood, blood products, plasma or blood cells of human
origin or to devices which incorporate at the time of placing on
the market such blood products, plasma or cells, with the exceptionof devices referred to in paragraph 4a;
(f) transplants or tissues or cells of human origin nor to products
incorporating or derived from tissues or cells of human origin;
(g) transplants or tissues or cells of animal origin, unless a device is
manufactured utilizing animal tissue which is rendered non-viableor non-viable products derived from animal tissue.
6. This Directive does not apply to personal protective equipment
covered by Directive 89/686/EEC. In deciding whether a product fallsunder that Directive or the present Directive, particular account shall betaken of the principal intended purpose of the product.
7. This Directive is a specific Directive within the meaning of
Article 2 (2) of Directive 89/336/EEC.
8. This Directive does not affect the application of Directive 80/836/
Euratom, nor of Directive 84/466/Euratom.
Article 2
Placingonthemarketandputtingintoservice
Member States shall take all necessary steps to ensure that devices may
be placed on the market and/or put into service only if they complywith the requirements laid down in this Directive when duly suppliedand properly installed, maintained and used in accordance with their
intended purpose.
Article 3
Essentialrequirements
The devices must meet the essential requirements set out in Annex I
which apply to them, taking account of the intended purpose of thedevices concerned.
Article 4
Free movement,devicesintendedforspecialpurposes
1. Member States shall not create any obstacle to the placing on the
market or the putting into service within their territory of devices
bearing the CE marking provided for in Article 17 which indicate that
they have been the subject of an assessment of their conformity inaccordance with the provisions of Article 11.
2. Member States shall not create any obstacle to:
— devices intended for clinical investigation being made available to
medical practitioners or authorized persons for that purpose if theymeet the conditions laid down in Article 15 and in Annex VIII,
— custom-made devices being placed on the market and put into
service if they meet the conditions laid down in Article 11 in
combination with Annex VIII; Class IIa, IIb and III devices shallbe accompanied by the statement referred to in Annex VIII.
These devices shall not bear the CE marking.
3. At trade fairs, exhibitions, demonstrations, etc. Member States
shall not create any obstacle to the showing of devices which do not1993L0042 — EN — 20.11.2003 — 004.001 — 8
(1) OJ No L 262, 27. 9. 1976, p. 169. Directive as last amended by Commission
Directive 92/86/EEC (OJ No L 325, 11. 11. 1992, p. 18).▼M3
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conform to this Directive, provided that a visible sign clearly indicates
that such devices cannot be marketed or put into service until they havebeen made to comply.
4. Member States may require the information, which must be made
available to the user and the patient in accordance with Annex I, point13, to be in their national language(s) or in another Community
language, when a device reaches the final user, regardless of whether
it is for professional or other use.
5. Where the devices are subject to other Directives concerning
other aspects and which also provide for the affixing of the CE
marking, the latter shall indicate that the devices also fulfil the provi-sions of the other Directives.
However, should one or more of these directives allow the manufac-
turer, during a transitional period, to choose which arrangements toapply, the CE marking shall indicate that the devices fulfil the provi-sions only of those directives applied by the manufacturer. In thiscase, the particulars of these directives, as published in the Official
Journal of the European Communities , must be given in the docu-
ments, notices or instructions required by the directives and
accompanying such devices.
Article 5
Reference tostandards
1. Member States shall presume compliance with the essential
requirements referred to in Article 3 in respect of devices which are
in conformity with the relevant national standards adopted pursuant tothe harmonized standards the references of which have been publishesin theOfficial Journal of the European Communities; Member States
shall publish the references of such national standards.
2. For the purposes of this Directive, reference to harmonized stan-
dards also includes the monographs of the European Pharmacopoeia
notably on surgical sutures and on interaction between medicinalproducts and materials used in devices containing such medicinal
products, the references of which have been published in the Official
Journal of the European Communities .
3. If a Member State or the Commission considers that the harmo-
nized standards do not entirely meet the essential requirements
referred to in Article 3, the measures to be taken by the Member Stateswith regard to these standards and the publication referred to in para-graph 1 of this Article shall be adopted by the procedure defined inArticle 6 (2).
Article 6
Committee onStandardsandTechnicalRegulations
1. The Commission shall be assisted by the Committee set upby
Article 5 of Directive 83/189/EEC, hereinafter referred to as ‘theCommittee’.
2. Where reference is made to this Article, Articles 3 and 7 of Deci-
sion 1999/468/EC(
1) shall apply, having regard to the provisions of
Article 8 thereof.
3. The Committee shall adopt its rules of procedure.1993L0042 — EN — 20.11.2003 — 004.001 — 9
(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).▼M4
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Article 7
1. The Commission shall be assisted by the Committee set upby
Article 6(2) of Directive 90/385/EEC, hereinafter referred to as ‘theCommittee’.
2. Where reference is made to this Article, Articles 5 and 7 of Deci-
sion 1999/468/EC(
1) shall apply, having regard to the provisions of
Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
3. The Committee shall adopt its rules of procedure.
4. The Committee may examine any question connected with imple-
mentation of this Directive.
Article 8
Safeguardclause
1. Where a Member State ascertains that the devices referred to in
Article 4 (1) and (2) second indent, when correctly installed, main-tained and used for their intended purpose, may compromise the
health and/or safety of patients, users or, where applicable, other
persons, it shall take all appropriate interim measures to withdrawsuch devices from the market or prohibit or restrict their being placedon the market or put into service. The Member State shall immediatelyinform the Commission of any such measures, indicating the reasonsfor 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;
(b) incorrect application of the standards referred to in Article 5, in so
far as it is claimed that the standards have been applied;
(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, afterconsulting the parties concerned, bring the matter before the
Committee referred to in Article 6 (1) within two months if the
Member State which has taken the decision intends to maintain itand shall initiate the procedures referred to in Article 6,
— the measures are unjustified, it shall immediately so inform the
Member State which took the initiative and the manufacturer orhis authorized representative established within the Community.
3. Where a non-complying device bears the CE marking, the compe-
tent Member State shall take appropriate action against whomsoeverhas affixed the mark and shall inform the Commission and the otherMember States thereof.
4. The Commission shall ensure that the Member States are kept
informed of the progress and outcome of this procedure.1993L0042 — EN — 20.11.2003 — 004.001 — 10
(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
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Article 9
Classification
1. Devices shall be divided into Classes I, IIa, IIb and III. Classifi-
cation shall be carried out in accordance with Annex IX.
2. In the event of a dispute between the manufacturer and the noti-
fied body concerned, resulting from the application of the classificationrules, the matter shall be referred for decision to the competentauthority to which the notified body is subject.
3. The classification rules set out in Annex IX may be adapted in
accordance with the procedure referred to in Article 7 (2) in the lightof technical progress and any information which becomes availableunder the information system provided for in Article 10.
Article 10
Information on incidents occuring following placing of devices on
themarket
1. Member States shall take the necessary steps to ensure that any
information brought to their knowledge, in accordance with the provi-sions of this Directive, regarding the incidents mentioned belowinvolving a Class I, IIa, IIb or III device is recorded and evaluatedcentrally:
(a) any malfunction or deterioration in the characteristics and/or
performance of a device, as well as any inadequacy in the labelling
or the instructions for use which might lead to or might have led tothe death of a patient or user or to a serious deterioration in hisstate of health;
(b) any technical or medical reason in relation to the characteristics or
performance of a device for the reasons referred to in subparagraph(a), leading to systematic recall of devices of the same type by themanufacturer.
2. Where a Member State requires medical practitioners or the
medical institutions to inform the competent authorities of any inci-
dents referred to in paragraph 1, it shall take the necessary steps toensure that the manufacturer of the device concerned, or his authorizedrepresentative established in the Community, is also informed of theincident.
3. After carrying out an assessment, if possible together with the
manufacturer, Member States shall, without prejudice to Article 8,immediately inform the Commission and the other Member States ofthe incidents referred to in paragraph 1 for which relevant measureshave been taken or are contemplated.
Article 11
Conformityassessmentprocedures
1. In the case of devices falling within Class III, other than devices
which are custom-made or intended for clinical investigations, themanufacturer shall, in order to affix the CE marking, either:
(a) follow the procedure relating to the EC declaration of conformity
set out in Annex II (full quality assurance); or
(b) follow the procedure relating to the EC type-examination set out in
Annex III, coupled with:
(i) the procedure relating to the EC verification set out in Annex
IV;
or
(ii) the procedure relating to the EC declaration of conformity set
out in Annex V (production quality assurance).
2. In the case of devices falling within Class IIa, other than devices
which are custom-made or intended for clinical investigations, themanufacturer shall, in order to affix the CE marking, follow the proce-1993L0042 — EN — 20.11.2003 — 004.001 — 11
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dure relating to the EC declaration of conformity set out in Annex VII,
coupled with either:
(a) the procedure relating to the EC verification set out in Annex IV;
or
(b) the procedure relating to the EC declaration of conformity set out
in Annex V (production quality assurance);
or
(c) the procedure relating to the EC declaration of conformity set out
in Annex VI (product quality assurance).
Instead of applying these procedures, the manufacturer may also follow
the procedure referred to in paragraph 3 (a).
3. In the case of devices falling within Class IIb, other than devices
which are custom-made or intended for clinical investigations, the
manufacturer shall, in order to affix the CE marking, either:
(a) follow the procedure relating to the EC declaration of conformity
set out in Annex II (full quality assurance); in this case, point 4 ofAnnex II is not applicable; or
(b) follow the procedure relating to the EC type-examination set out in
Annex III, coupled with:
(i) the procedure relating to the EC verification set out in Annex
IV;
or
(ii) the procedure relating to the EC declaration of conformity set
out in Annex V (production quality assurance);
or
(iii) the procedure relating to the EC declaration of conformity set
out in Annex VI (product quality assurance).
4. The Commission shall, no later than five years from the date of
implementation of this Directive, submit a report to the Council on
the operation of the provisions referred to in Article 10 (1), Article 15
(1), in particular in respect of Class I and Class IIa devices, and on theoperation of the provisions referred to in Annex II, Section 4.3 secondand third subparagraphs and in Annex III, Section 5 second and thirdsubparagraphs to this Directive, accompanied, if necessary, by appro-
priate proposals.
5. In the case of devices falling within Class I, other than devices
which are custom-made or intended for clinical investigations, themanufacturer shall, in order to affix the CE marking, follow the proce-dure referred to in Annex VII and draw upthe EC declaration ofconformity required before placing the device on the market.
6. In the case of custom-made devices, the manufacturer shall
follow the procedure referred to in Annex VIII and draw up the state-ment set out in that Annex before placing each device on the market.
Member States may require that the manufacturer shall submit to the
competent authority a list of such devices which have been put intoservice in their territory.
7. During the conformity assessment procedure for a device, the
manufacturer and/or the notified body shall take account of the results
of any assessment and verification operations which, where appro-priate, have been carried out in accordance with this Directive at anintermediate stage of manufacture.
8. The manufacturer may instruct his authorized representative
established in the Community to initiate the procedures provided for
in Annexes III, IV, VII and VIII.
9. 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.1993L0042 — EN — 20.11.2003 — 004.001 — 12
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10. The notified body may require, where duly justified, any infor-
mation or data, which is necessary for establishing and maintaining theattestation of conformity in view of the chosen procedure.
11. 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 both parties, for further periods of five years.
12. The records and correspondence relating to the procedures
referred to in paragraphs 1 to 6 shall be in an official language of theMember State in which the procedures are carried out and/or in anotherCommunity language acceptable to the notified body.
13. By derogation from paragraphs 1 to 6, the competent authorities
may authorize, on duly justified request, the placing on the market and
putting into service, within the territory of the Member Stateconcerned, of individual devices for which the procedures referred toin paragraphs 1 to 6 have not been carried out and the use of which isin the interest of protection of health.
Article 12
Particularprocedureforsystemsandprocedurepacks
1. By way of derogation from Article 11 this Article shall apply to
systems and procedure packs.
2. Any natural or legal person who puts devices bearing the CE
marking together within their intended purpose and within the limitsof use specified by their manufacturers, in order to place them on themarket as a system or procedure pack, shall draw up a declaration by
which he states that:
(a) he has verified the, mutual compatibility of the devices in accor-
dance with the manufacturers' instructions and has carried out hisoperations in accordance with these instructions; and
(b) he has packaged the system or procedure pack and supplied rele-
vant information to users incorporating relevant instructions from
the manufacturers; and
(c) the whole activity is subjected to appropriate methods of internal
control and inspection.
Where the conditions above are not met, as in cases where the system
or procedure pack incorporate devices which do not bear a CE markingor where the chosen combination of devices is not compatible in view
of their original intended use, the system or procedure pack shall be
treated as a device in its own right and as such be subjected to the rele-vant procedure pursuant to Article 11.
3. Any natural or legal person who sterilized, for the purpose of
placing on the market, systems or procedure packs referred to in para-graph 2 or other CE-marked medical devices designed by theirmanufacturers to be sterilized before use, shall, at his choice, follow
one of the procedures referred to in Annex IV, V or VI. The applica-
tion of the abovementioned Annexes and the intervention of thenotified body are limited to the aspects of the procedure relating tothe obtaining of sterility. The person shall draw up a declaration statingthat sterilization has been carried out in accordance with the manufac-turer's instructions.
4. The products referred to in paragraphs 2 and 3 themselves shall
not bear an additional CE marking. They shall be accompanied by the
information referred to in point 13 of Annex I which includes, whereappropriate, the information supplied by the manufacturers of thedevices which have been put together. The declaration referred to inparagraphs 2 and 3 above shall be kept at the disposal of competentauthorities for a period of five years.1993L0042 — EN — 20.11.2003 — 004.001 — 13
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Article 13
Decisionswithregard toclassification, derogationclause
1. Where a Member State considers that:
(a) application of the classification rules set out in Annex IX requires a
decision with regard to the classification of a given device or cate-gory of devices;
or
(b) a given device or family of devices should be classified, by way of
derogation from the provisions of Annex IX, in another class;
or
(c) the conformity of a device or family of devices should be estab-
lished, by way of derogation from the provisions of Article 11, byapplying solely one of the given procedures chosen from amongthose referred to in Article 11,
it shall submit a duly substantiated request to the Commission and ask
it to take the necessary measures. These measures shall be adopted inaccordance with the procedure referred to in Article 7 (2).
2. The Commission shall inform the Member States of the measures
taken and, where appropriate, publish the relevant parts of these
measures in the Official Journal of the European Communities .
Article 14
Registration of persons responsible for placing devices on the
market
1. Any manufacturer who, under his own name, places devices on
the market in accordance with the procedures referred to in Article 11
(5) and (6) and any other natural or legal person engaged in the activ-
ities referred to in Article 12 shall inform the competent authorities ofthe Member State in which he has his registered place of business ofthe address of the registered place of business and the description ofthe devices concerned.
For all medical devices of classes IIb and III, Member States may
request to be informed of all data allowing for identification of such
devices together with the label and the instructions for use when such
devices are put into service within their territory.
2. Where a manufacturer who places devices referred to in para-
graph 1 on the market under his own name does not have a registeredplace of business in a Member State, he shall designate the person(s)responsible for marketing them who is (are) established in the Commu-
nity. These persons shall inform the competent authorities of the
Member State in which they have their registered place of business ofthe address of the registered place of business and the category ofdevices concerned.
3. The Member States shall on request inform the other Member
States and the Commission of the details referred to in paragraphs 1and 2.
Article 14a
Europeandatabank
1. Regulatory data in accordance with this Directive shall be stored
in a European database accessible to the competent authorities toenable them to carry out their tasks relating to this Directive on awell-informed basis.1993L0042 — EN — 20.11.2003 — 004.001 — 14
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The databank shall contain the following:
(a) data relating to registration of manufacturers and devices in accor-
dance with Article 14;
(b) data relating to certificates issued, modified, supplemented,
suspended, withdrawn or refused according to the procedures, as
laid down in Annexes II to VII;
(c) data obtained in accordance with the vigilance procedure as defined
in Article 10;
2. Data shall be forwarded in a standardised format.3. The procedures implementing this Article shall be adopted in
accordance with the procedure laid down in Article 7(2).
Article 14b
Particular healthmonitoringmeasures
Where a Member State considers, in relation to a given product or
group of products, that, in order to ensure protection of health andsafety and/or to ensure that public health requirements are observed
pursuant to Article 36 of the Treaty, the availability of such products
should be prohibited, restricted or subjected to particular requirements,it may take any necessary and justified transitional measures. It shallthen inform the Commission and all the other Member States givingthe reasons for its decision. The Commission shall, whenever possible,consult the interested parties and the Member States and, where the
national measures are justified, adopt necessary Community measures
in accordance with the procedure referred to in Article 7(2).
Article 15
Clinicalinvestigation
1. In the case of devices intended for clinical investigations, the
manufacturer, or his authorized representative established in theCommunity, shall follow the procedure referred to in Annex VIII andnotify the competent authorities of the Member States in which the
investigations are to be conducted.
2. In the case of devices falling within Class III and implantable and
long-term invasive devices falling within Class IIa or IIb, the manufac-
turer may commence the relevant clinical investigation at the end of aperiod of 60 days after notification, unless the competent authoritieshave notified him within that period of a decision to the contrary basedon considerations of public health or public policy.
Member States may however authorize manufacturers to commence the
relevant clinical investigations before the expiry of the period of 60days, in so far as the relevant ethics committee has issued a favourable
opinion on the programme of investigation in question.
3. In the case of devices other than those referred to in the second
paragraph, Member States may authorize manufacturers to commence
clinical investigations, immediately after the date of notification,provided that the ethics committee concerned has delivered a favour-able opinion with regard to the investigational plan.
4. The authorization referred to in paragraph 2 second subparagraph
and paragraph 3, may be made subject to authorization from thecompetent authority.
5. The clinical investigations must be conducted in accordance with
the provisions of Annex X. The provisions of Annex X may beadjusted in accordance with the procedure laid down in Article 7 (2).
6. The Member States shall, if necessary, take the appropriate steps
to ensure public health and public policy.1993L0042 — EN — 20.11.2003 — 004.001 — 15
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7. The manufacturer or his authorized representative established in
the Community shall keep the report referred to in point 2.3.7 ofAnnex X at the disposal of the competent authorities.
8. The provisions of paragraphs 1 and 2 do not apply where the clin-
ical investigations are conducted using devices which are authorized in
accordance with Article 11 to bear the CE marking unless the aim of
these investigations is to use the devices for a purpose other than thatreferred to in the relevant conformity assessment procedure. The rele-vant provisions of Annex X remain applicable.
Article 16
Notifiedbodies
1. The Member States shall notify the Commission and other
Member States of the bodies which they have designated for carryingout the tasks pertaining to the procedures referred to in Article 11 and
the specific tasks for which the bodies have been designated. The
Commission shall assign identification numbers to these bodies, herein-after referred to as ‘notified bodies’.
The Commission shall publish a list of the notified bodies, together
with the identification numbers it has allocated to them and the tasksfor which they have been notified, in the Official Journal of the
European Communities . It shall ensure that the list is kept up to date.
2. Member States shall apply the criteria set out in Annex XI for the
designation of bodies. Bodies that meet the criteria laid down in thenational standards which transpose the relevant harmonized standardsshall be presumed to meet the relevant 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 States
and the Commission thereof.
4. The notified body and the manufacturer, or his authorized repre-
sentative established in the Community, shall lay down, by common
accord, the time limits for completion of the assessment and verifica-
tion operations referred to in Annexes II to VI.
5. The notified body shall inform the other notified bodies and the
competent authority about all certificates suspended or withdrawn and,
on request, about certificates issued or refused. It shall also make avail-
able, on request, all additional relevant information.
6. Where a notified body finds that pertinent requirements of this
Directive have not been met or are no longer met by the manufactureror where a certificate should not have been issued, it shall, takingaccount of the principle of proportionality, suspend or withdraw thecertificate issued or place any restrictions on it unless compliancewith such requirements is ensured by the implementation of appropriate
corrective measures by the manufacturer. In the case of suspension or
withdrawal of the certificate or of any restriction placed on it or incases where an intervention of the competent authority may becomenecessary, the notified body shall inform its competent authoritythereof. The Member State shall inform the other Member States and
the Commission.
7. The notified body shall, on request, supply all relevant informa-
tion and documents including budgetary documents, required to enable
the Member State to verify compliance with Annex XI requirements.
Article 17
CEmarking
1. Devices, other than devices which are custom-made or intended
for clinical investigations, considered to meet the essential require-1993L0042 — EN — 20.11.2003 — 004.001 — 16
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ments referred to in Article 3 must bear the CE marking of conformity
when they are placed on the market.
2. The CE marking of conformity, as shown in Annex XII, must
appear in a visible, legible and indelible form on the device or itssterile pack, where practicable and appropriate, and on the instructionsfor use. Where applicable, the CE marking must also appear on thesales packaging.
It shall be accompanied by the identification number of the notified
body responsible for implementation of the procedures set out in
Annexes II, IV, V and VI.
3. It is prohibited to affix marks or inscriptions which are likely to
mislead third parties with regard to the meaning or the graphics of theCE marking. Any other mark may be affixed to the device, to the
packaging or to the instruction leaflet accompanying the device
provided that the visibility and legibility of the CE marking is notthereby reduced.
Article 18
WronglyaffixedCEmarking
Without prejudice to Article 8:
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his authorized representative
established 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 product in question or to ensure that it is withdrawnfrom the market, in accordance with the procedure in Article 8.
Those provisions shall also apply where the CE marking has been
affixed in accordance with the procedures in this Directive, but inap-propriately, on products that are not covered by this Directive.
Article 19
Decisioninrespect ofrefusalorrestriction
1. Any decision taken pursuant to this Directive:
(a) to refuse or restrict the placing on the market or the putting into
service of a device or the carrying out of clinical investigations;
or
(b) to withdraw devices from the market,
shall state the exact grounds on which it is based. Such decisions shall
be notified without delay to the party concerned, who shall at the sametime be informed of the remedies available to him under the nationallaw in force in the Member State in question and of the time limits towhich such remedies are subject.
2. In the event of a decision as referred to in paragraph 1, the manu-
facturer, or his authorized representative established in the Community,shall have an opportunity to put forward his viewpoint in advance,unless such consultation is not possible because of the urgency of themeasure to be taken.
Article 20
Confidentiality
Without prejudice to the existing national provisions and practices on
medical secrets, Member States shall ensure that all the partiesinvolved in the application of this Directive are bound to observeconfidentiality with regard to all information obtained in carrying outtheir tasks. This does not affect the obligation of Member States and1993L0042 — EN — 20.11.2003 — 004.001 — 17
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notified bodies with regard to mutual information and the dissemina-
tion of warnings, nor the obligations of the persons concerned toprovide information under criminal law.
Article 21
RepealandamendmentofDirectives
1. Directive 76/764/EEC is hereby repealed with effect from 1
January 1995.
2. In the title and Article 1 of Directive 84/539/EEC, ‘human or’ is
deleted.
In Article 2 of Directive 84/539/EEC, the following subparagraph is
added to paragraph 1:
‘If the appliance is at the same time a medical device within the
meaning of Directive 93/42/EEC (*) and if it satisfies the essentialrequirements laid down therein for that device, the device shall bedeemed to be in conformity with the requirements of this Directive.
(*) OJ No L 169, 12. 7. 1993, p. 1.’
3. Directive 90/385/EEC is hereby amended as follows:1. in Article 1 (2) the following two subparagraphs are added:
‘(h) “placing on the market” means the first making available in
return for payment or free of charge of a device other than a
device intended for clinical investigation, with a view to distri-bution and/or use on the Community market, regardless ofwhether it is new or fully refurbished;
(i) “manufacturer” means the natural or legal person with respon-
sibility for the design, manufacture, packaging and labelling ofa device before it is placed on the market under his own name,regardless of whether these operations are carried out by thatperson himself or 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 ormore ready-made products and/or assigns to them their
intended purpose as a device with a view to their being placed
on the market under his own name. This subparagraph does notapply to the person who, while not a manufacturer within themeaning of the first subparagraph, assembles or adapts devicesalready on the market to their intended purpose for an indivi-
dual patient;’
2. in Article 9 the following paragraphs are added:
‘5. During the conformity assessment procedure for a device, the
manufacturer and/or the notified body shall take account of theresults of any assessment and verification operations which, whereappropriate, have been carried out in accordance with this Directiveat 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 bodyof his choice within the framework of the tasks for which the body
has been notified.
7. The notified body may require, where duly justified, any infor-
mation or data which is necessary for establishing and maintainingthe 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 andmay be extended on application, made at a time agreed in the
contract signed by both parties, for further periods of five years.
9. By derogation from paragraphs 1 and 2 the competent authori-
ties may authorize, on duly justified request, the placing on themarket and putting into service, within the territory of the Member1993L0042 — EN — 20.11.2003 — 004.001 — 18
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State concerned, of individual devices for which the procedures
referred to in paragraphs 1 and 2 have not been carried out and theuse of which is in the interest of protection of health.’;
3. the following Article 9a is inserted after Article 9:
‘Article 9a
1. Where a Member State considers that the conformity of a
device or family of devices should be established, by way of deroga-
tion from the provisions of Article 9, by applying solely one of the
given procedures chosen from among those referred to in Article 9,it shall submit a duly substantiated request to the Commission andask it to take the necessary measures. These measures shall beadopted in accordance with the procedure referred to in Article 7
(2) of Directive 93/42/EEC (*).
2. The Commission shall inform the Member States of the
measures taken and, where appropriate, publish the relevant parts
of these measures in the Official Journal of the European Commu-
nities.
(*) OJ No L 169, 12. 7. 1993, p. 1.’
4. Article 10 shall be amended as follows:
— the following subparagraph shall be added to paragraph 2:
‘Member States may however authorize manufacturers to start
the clinical investigations in question before the expiry of the
60-day period, provided that the Ethical Committee concerned
has delivered a favourable opinion with respect to the investiga-tion programme in question.’,
— the following paragraph shall be inserted:
‘2a. The authorization referred to in the second subparagraph
of paragraph 2 may be subject to approval by the competentauthority.’;
5. the following is added to Article 14:
‘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 viewpointin advance, unless such consultation is not possible because of theurgency of the measures to be taken.’
Article 22
Implementation,transitionalprovisions
1. Member States shall adopt and publish the laws, regulations and
administrative provisions necessary to comply with this Directive not
later than 1 July 1994. They shall immediately inform the Commission
thereof.
The Standing Committee referred to in Article 7 may assume its tasks
from the date of notification(
1) of this Directive. The Member States
may take the measures referred to in Article 16 on notification of thisDirective.
When Member States adopt these provisions, these shall contain a
reference to this Directive or shall be accompanied by such a reference
at the time of their official publication. The procedure for such refer-ence shall be adopted by Member States.
Member States shall apply these provisions with effect from 1 January
1995.
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.1993L0042 — EN — 20.11.2003 — 004.001 — 19
(1) This Directive was notified to the Member States on 29 June 1993.
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3. Member States shall take the necessary action to ensure that the
notified bodies which are responsible pursuant to Article 11 (1) to (5)for conformity assessment take account of any relevant information
regarding the characteristics and performance of such devices,
including in particular the results of any relevant tests and verificationalready carried out under pre-existing national law, regulations oradministrative provisions in respect of such devices.
4. Member States shall accept:
— devices which conform to the rules in force in their territory on 31
December 1994 being placed on the market during a period of fiveyears following the adoption of this Directive, and
— the aforementioned devices being put into service until 30 June
2001 at the latest.
In the case of devices which have been subjected to EEC pattern
approval in accordance with Directive 76/764/EEC, Member States
shall accept their being placed on the market and put into serviceduring the period up to 30 June 2004.
Article 23
This Directive is addressed to the Member States.1993L0042 — EN — 20.11.2003 — 004.001 — 20
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ANNEX I
ESSENTIALREQUIREMENTS
I. GENERAL REQUIREMENTS
1. The devices must be designed and manufactured in such a way that,
when used under the conditions and for the purposes intended, they
will not compromise the clinical condition or the safety of patients, or
the safety and health of users or, where applicable, other persons,
provided that any risks which may be associated with their use consti-
tute acceptable risks when weighed against the benefits to the patient
and are compatible with a high level of protection of health and safety.
2. The solutions adopted by the manufacturer for the design and construc-
tion of the devices must conform to safety principles, taking account of
the generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer must apply
the following principles in the following order:
— eliminate or reduce risks as far as possible (inherently safe design
and construction),
— where appropriate take adequate protection measures including
alarms if necessary, in relation to risks that cannot be eliminated,
— inform users of the residual risks due to any shortcomings of the
protection measures adopted.
3. The devices must achieve the performances intended by the manufac-
turer and be designed, manufactured and packaged 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 the manufacturer.
4. The characteristics and performances referred to in Sections 1, 2 and 3
must not be adversely affected to such a degree that the clinical condi-
tions and safety of the patients and, where applicable, of other persons
are compromised during the lifetime of the device as indicated by the
manufacturer, when the device is subjected to the stresses which can
occur during normal conditions of use.
5. The devices must be designed, manufactured and packed in such a way
that their characteristics and performances during their intended use will
not be adversely affected during transport and storage taking account of
the instructions and information provided by the manufacturer.
6. Any undesirable side-effect must constitute an acceptable risk when
weighed against the performances intended.
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
7.Chemical,physicalandbiological properties
7.1. The devices must be designed and manufactured in such a way as to
guarantee the characteristics and performances referred to in Section I
on the ‘General requirements’. Particular attention must be paid to:
— the choice of materials used, particularly as regards toxicity and,
where appropriate, flammability,
— the compatibility between the materials used and biological tissues,
cells and body fluids, taking account of the intended purpose of the
device.
7.2. The devices must be designed, manufactured and packed in such a way
as to minimize the risk posed by contaminants and residues to the
persons involved in the transport, storage and use of the devices and to
the patients, taking account of the intended purpose of the product.
Particular attention must be paid to the tissues exposed and to the dura-
tion and frequency of exposure.
7.3. The devices must be designed and manufactured in such a way that they
can be used safely with the materials, substances and gases with which
they enter into contact during their normal use or during routine proce-
dures; if the devices are intended to administer medicinal products they
must be designed and manufactured in such a way as to be compatible
with the medicinal products concerned according to the provisions and
restrictions governing these products and that their performance is main-
tained in accordance with the intended use.1993L0042 — EN — 20.11.2003 — 004.001 — 21
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7.4. Where a device incorporates, as an integral part, a substance which, if
used separately, may be considered to be a medicinal product as defined
in Article 1 of Directive 65/65/EEC and which is liable to act upon the
body with action ancillary to that of the device, the safety, quality and
usefulness of the substance must be verified, taking account of the
intended purpose of the device, by analogy with the appropriate methods
specified in Directive 75/318/EEC.
Where a device incorporates, as an integral part, a human blood deriva-
tive, the notified body shall seek a scientific opinion from the European
Agency for the Evaluation of Medicinal Products (EMEA) on the
quality and safety of the derivative, taking account of the appropriateCommunity provisions and, in particular, by analogy with the provisions
of Directives 75/318/EEC and 89/381/EEC. The usefulness of the deri-
vative as a part of the medical device shall be verified, taking account
of the intended purpose of the device.
In accordance with Article 4(3) of Directive 89/381/EEC, a sample from
each batch of bulk and/or finished product of the human blood deriva-
tive shall be tested by a State laboratory or a laboratory designated for
that purpose by a Member State.
7.5. The devices must be designed and manufactured in such a way as to
reduce to a minimum the risks posed by substances leaking from the
device.
7.6. Devices must be designed and manufactured in such a way as to reduce,
as much as possible, risks posed by the unintentional ingress of
substances into the device taking into account the device and the nature
of the environment in which it is intended to be used.
8.Infectionandmicrobial contamination
8.1. The devices and manufacturing processes must be designed in such a
way as to eliminate or reduce as far as possible the risk of infection to
the patient, user and third parties. The design must allow easy handling
and, where necessary, minimize contamination of the device by the
patient or vice versa during use.
8.2. Tissues of animal origin must originate from animals that have been
subjected to veterinary controls and surveillance adapted to the intended
use of the tissues.
Notified bodies shall retain information on the geographical origin of the
animals.
Processing, preservation, testing and handling of tissues, cells and
substances of animal origin must be carried out so as to provide optimal
security. In particular safety with regard to viruses and other transferable
agents must be addressed by implementation of validated methods of
elimination or viral inactivation in the course of the manufacturing
process.
8.3. Devices delivered in a sterile state must be designed, manufactured and
packed in a non-reusable pack and/or according to appropriate proce-
dures to ensure that they are sterile when placed on the market and
remain sterile, under the storage and transport conditions laid down,
until the protective packaging is damaged or opened.
8.4. Devices delivered in a sterile state must have been manufactured and
sterilized by an appropriate, validated method.
8.5. Devices intended to be sterilized must be manufactured in appropriately
controlled (e. g. environmental) conditions.
8.6. Packaging systems for non-sterile devices must keepthe p roduct without
deterioration at the level of cleanliness stipulated and, if the devices are
to be sterilized prior to use, minimize the risk of microbial contamina-
tion; the packaging system must be suitable taking account of the
method of sterilization indicated by the manufacturer.
8.7. The packaging and/or label of the device must distinguish between iden-
tical or similar products sold in both sterile and non-sterile condition.
9.Constructionandenvironmentalproperties
9.1. If the device is intended for use in combination with other devices or
equipment, the whole combination, including the connection system
must be safe and must not impair the specified performances of the1993L0042 — EN — 20.11.2003 — 004.001 — 22
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devices. Any restrictions on use must be indicated on the label or in the
instructions for use.
9.2. Devices must be designed and manufactured in such a way as to remove
or minimize as far as is possible:
— the risk of injury, in connection with their physical features,
including the volume/pressure ratio, dimensional and where appro-
priate ergonomic features,
— risks connected with reasonably foreseeable environmental condi-
tions, such as magnetic fields, external electrical influences,
electrostatic discharge, pressure, temperature or variations in pres-
sure and acceleration,
— the risks of reciprocal interference with other devices normally used
in the investigations or for the treatment given,
— risks arising where maintenance or calibration are not possible (as
with implants), from ageing of materials used or loss of accuracy
of any measuring or control mechanism.
9.3. Devices must be designed and manufactured in such a way as to mini-
mize the risks of fire or explosion during normal use and in single fault
condition. Particular attention must be paid to devices whose intended
use includes exposure to flammable substances or to substances which
could cause combustion.
10.Deviceswithameasuringfunction
10.1. Devices with a measuring function must be designed and manufactured
in such a way as to provide sufficient accuracy and stability within
appropriate limits of accuracy and taking account of the intended
purpose of the device. The limits of accuracy must be indicated by the
manufacturer.
10.2. The measurement, monitoring and display scale must be designed in line
with ergonomic principles, taking account of the intended purpose of the
device.
10.3. The measurements made by devices with a measuring function must be
expressed in legal units conforming to the provisions of Council Direc-
tive 80/181/EEC(1).
11.Protection againstradiation
11.1.General
11.1.1. Devices shall be designed and manufactured in such a way that exposure
of patients, users and other persons to radiation shall be reduced as far
as possible compatible with the intended purpose, whilst not restricting
the application of appropriate specified levels for therapeutic and diag-
nostic purposes.
11.2.Intended radiation
11.2.1. Where devices are designed to emit hazardous levels of radiation neces-
sary for a specific medical purpose the benefit of which is considered to
outweigh the risks inherent in the emission, it must be possible for the
user to control the emissions. Such devices shall be designed and manu-
factured to ensure reproducibility and tolerance of relevant variable
parameters.
11.2.2. Where devices are intended to emit potentially hazardous, visible and/or
invisible radiation, they must be fitted, where practicable, with visual
displays and/or audible warnings of such emissions.
11.3.Unintended radiation
11.3.1. Devices shall be designed and manufactured in such a way that exposure
of patients, users and other persons to the emission of unintended, stray
or scattered radiation is reduced as far as possible.
11.4.Instructions
11.4.1. The operating instructions for devices emitting radiation must give
detailed information as to the nature of the emitted radiation, means of
protecting the patient and the user and on ways of avoiding misuse and
of eliminating the risks inherent in installation.1993L0042 — EN — 20.11.2003 — 004.001 — 23
(1) OJ No L 39, 15. 2. 1980, p. 40. Directive as last amended by Directive 89/617/EEC
(OJ No L 357, 7. 12. 1989, p. 28).
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11.5.Ionizing radiation
11.5.1. Devices intended to emit ionizing radiation must be designed and manu-
factured in such a way as to ensure that, where practicable, the quantity,geometry and quality of radiation emitted can be varied and controlled
taking into account the intended use.
11.5.2. Devices emitting ionizing radiation intended for diagnostic radiology
shall be designed and manufactured in such a way as to achieve appro-
priate image and/or output quality for the intended medical purpose
whilst minimizing radiation exposure of the patient and user.
11.5.3. Devices emitting ionizing radiation, intended for therapeutic radiology
shall be designed and manufactured in such a way as to enable reliable
monitoring and control of the delivered dose, the beam type and energy
and where appropriate the quality of radiation.
12.Requirementsformedicaldevicesconnectedtoorequippedwithan
energysource
12.1. Devices incorporating electronic programmable systems must be
designed to ensure the repeatability, reliability and performance of these
systems according to the intended use. In the event of a single fault
condition (in the system) appropriate means should be adopted to elim-
inate or reduce as far as possible consequent risks.
12.2. Devices where the safety of the patients depends on an internal power
supply must be equipped with a means of determining the state of the
power supply.
12.3. Devices where the safety of the patients depends on an external power
supply must include an alarm system to signal any power failure.
12.4. Devices intended to monitor one or more clinical parameters of a patient
must be equipped with appropriate alarm systems to alert the user of
situations which could lead to death or severe deterioration of the
patient's state of health.
12.5. Devices must be designed and manufactured in such a way as to mini-
mize the risks of creating electromagnetic fields which could impair the
operation of other devices or equipment in the usual environment.
12.6.Protection against electrical risks
Devices must be designed and manufactured in such a way as to avoid,
as far as possible, the risk of accidental electric shocks during normal
use and in single fault condition, provided the devices are installed
correctly.
12.7.Protection against mechanical and thermal risks
12.7.1. Devices must be designed and manufactured in such a way as to protect
the patient and user against mechanical risks connected with, for
example, resistance, stability and moving parts.
12.7.2. Devices must be designed and manufactured in such a way as to reduce
to the lowest possible level the risks arising from vibration generated by
the devices, taking account of technical progress and of the means avail-
able for limiting vibrations, particularly at source, unless the vibrations
are part of the specified performance.
12.7.3. Devices must be designed and manufactured in such a way as to reduce
to the lowest possible level the risks arising from the noise emitted,
taking account of technical progress and of the means available to
reduce noise, particularly at source, unless the noise emitted is part of
the specified performance.
12.7.4. Terminals and connectors to the electricity, gas or hydraulic and pneu-
matic energy supplies which the user has to handle must be designed
and constructed in such a way as to minimize all possible risks.
12.7.5. Accessible parts of the devices (excluding the parts or areas intended to
supply heat or reach given temperatures) and their surroundings must
not attain potentially dangerous temperatures under normal use.
12.8.Protection against the risks posed to the patient by energy supplies or
substances
12.8.1. Devices for supplying the patient with energy or substances must be
designed and constructed in such a way that the flow-rate can be set
and maintained accurately enough to guarantee the safety of the patient
and of the user.1993L0042 — EN — 20.11.2003 — 004.001 — 24
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12.8.2. Devices must be fitted with the means of preventing and/or indicating
any inadequacies in the flow-rate which could pose a danger.
Devices must incorporate suitable means to prevent, as far as possible,
the accidental release of dangerous levels of energy from an energy and/
or substance source.
12.9.The function of the controls and indicators must be clearly specified on
the devices.
Where a device bears instructions required for its operation or indicates
operating or adjustment parameters by means of a visual system, such
information must be understandable to the user and, as appropriate, the
patient.
13.Informationsuppliedbythemanufacturer
13.1. Each device must be accompanied by the information needed to use it
safely and to identify the manufacturer, taking account of the training
and knowledge of the potential users.
This information comprises the details on the label and the data in the
instructions for use.
As far as practicable and appropriate, the information needed to use the
device safely must be set out on the device itself and/or on the packa-
ging for each unit or, where appropriate, on the sales packaging. If
individual packaging of each unit is not practicable, the information
must be set out in the leaflet supplied with one or more devices.
Instructions for use must be included in the packaging for every device.
By way of exception, no such instructions for use are needed for devices
in Class I or IIa if they can be used safely without any such instructions.
13.2. Where appropriate, this information should take the form of symbols.
Any symbol or identification colour used must conform to the harmo-
nized standards. In areas for which no standards exist, the symbols and
colours must be described in the documentation supplied with the
device.
13.3.The label must bear the following particulars:
(a) the name or trade name and address of the manufacturer. For
devices imported into the Community, in view of their distribution
in the Community, the label, or the outer packaging, or instructions
for use, shall contain in addition the name and address of either the
person responsible referred to in Article 14 (2) or of the authorized
representative of the manufacturer established within the Commu-
nity or of the importer established within the Community, asappropriate;
(b) the details strictly necessary for the user to identify the device and
the contents of the packaging;
(c) where appropriate, the word ‘STERILE’;
(d) where appropriate, the batch code, preceded by the word ‘LOT’, or
the serial number;
(e) where appropriate, an indication of the date by which the device
should be used, in safety, expressed as the year and month;
(f) where appropriate, an indication that the device is for single use;
(g) if the device is costum-made, the words ‘custom-made device’;
(h) if the device is intended for clinical investigations, the words
‘exclusively for clinical investigations’;
(i) any special storage and/or handling conditions;
(j) any special operating instructions;
(k) any warnings and/or precautions to take;
(l) year of manufacture for active devices other than those covered by
(e). This indication may be included in the batch or serial number;
(m) where applicable, method of sterilization;
(n) in the case of a device within the meaning of Article 1(4a), an indi-
cation that the device contains a human blood derivative.
13.4. If the intended purpose of the device is not obvious to the user, the
manufacturer must clearly state it on the label and in the instructions
for use.1993L0042 — EN — 20.11.2003 — 004.001 — 25
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13.5. Wherever reasonable and practicable, the devices and detachable
components must be identified, where appropriate in terms of batches,
to allow all appropriate action to detect any potential risk posed by the
devices and detachable components.
13.6. Where appropriate, the instructions for use must contain the following
particulars:
(a) the details referred to in Section 13.3, with the exception of (d) and
(e);
(b) the performances referred to in Section 3 and any undesirable side-
effects;
(c) if the device must be installed with or connected to other medical
devices or equipment in order to operate as required for its intended
purpose, sufficient details of its characteristics to identify the correct
devices or equipment to use in order to obtain a safe combination;
(d) all the information needed to verify whether the device is properly
installed and can operate correctly and safely, plus details of the
nature and frequency of the maintenance and calibration needed to
ensure that the devices operate properly and safely at all times;
(e) where appropriate, information to avoid certain risks in connection
with implantation of the device;
(f) information regarding the risks of reciprocal interference posed by
the presence of the device during specific investigations or treat-
ment;
(g) the necessary instructions in the event of damage to the sterile
packaging and, where appropriate, details of appropriate methods
of resterilization;
(h) if the device is reusable, information on the appropriate processes to
allow reuse, including cleaning, disinfection, packaging and, where
appropriate, the method of sterilization of the device to be resteri-
lized, and any restriction on the number of reuses.
Where devices are supplied with the intention that they be sterilized
before use, the instructions for cleaning and sterilization must be
such that, if correctly followed, the device will still comply with
the requirements in Section I;
(i) details of any further treatment or handling needed before the device
can be used (for example, sterilization, final assembly, etc.);
(j) in the case of devices emitting radiation for medical purposes,
details of the nature, type, intensity and distribution of this radiation.
The instructions for use must also include details allowing the medical
staff to brief the patient on any contra-indications and any precautions to
be taken. These details should cover in particular:
(k) precautions to be taken in the event of changes in the performance
of the device;
(l) precautions to be taken as regards exposure, in reasonably foresee-
able environmental conditions, to magnetic fields, external
electrical influences, electrostatic discharge, pressure or variations
in pressure, acceleration, thermal ignition sources, etc.;
(m) adequate information regarding the medicinal product or products
which the device in question is designed to administer, including
any limitations in the choice of substances to be delivered;
(n) precautions to be taken against any special, unusual risks related to
the disposal of the device;
(o) medicinal substances incorporated into the device as an integral
part in accordance with Section 7.4;
(p) degree of accuracy claimed for devices with a measuring function.
14. Where conformity with the essential requirements must be based on
clinical data, as in Section I (6), such data must be established in accor-
dance with Annex X.1993L0042 — EN — 20.11.2003 — 004.001 — 26
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ANNEX II
ECDECLARATIONOFCONFORMITY
(Fullqualityassurancesystem)
1. The manufacturer must ensure application of the quality system approved
for the design, manufacture and final inspection of the products concerned,
as specified in Section 3 and is subject to audit as laid down in Sections 3.3
and 4 and to Community surveillance as specified in Section 5.
2. The declaration of conformity is the procedure whereby the manufacturer
who fulfils the obligations imposed by Section 1 ensures and declares that
the products concerned meet the provisions of this Directive which apply to
them.
The manufacturer must affix the CE marking in accordance with Article 17
and draw upa written declaration of conformity. This declaration must
cover a given number of the products manufactured and be kept by the
manufacturer.
3.Qualitysystem
3.1. The manufacturer must lodge an application for assessment of his quality
system with a notified body.
The application must include:
— the name and address of the manufacturer and any additional manufac-
turing site covered by the quality system,
— all the relevant information on the product or product category covered
by the procedure,
— a written declaration that no application has been lodged with any other
notified body for the same product-related quality system,
— the documentation on the quality system,
— an undertaking by the manufacturer to fulfil the obligations imposed by
the quality system approved,
— an undertaking by the manufacturer to keep the approved quality
system adequate and efficacious,
— an undertaking by the manufacturer to institute and keepupto date a
systematic procedure to review experience gained from devices in the
post-production phase and to implement appropriate means to apply
any necessary corrective action. This undertaking must include an obli-
gation for the manufacturer to notify the competent authorities of the
following incidents immediately on learning of them:
(i) any malfunction or deterioration in the characteristics and/or perfor-
mance of a device, as well as any inadequacy in the instructions for
use which might lead to or might have led to the death of a patient
or user or to a serious deterioration in his state of health;
(ii) any technical or medical reason connected with the characteristics
or performance of a device leading for the reasons referred to in
subparagraph (i) to systematic recall of devices of the same type
by the manufacturer.
3.2. 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 inspection. All the elements, requirements and provisions
adopted by the manufacturer for his quality system must be documented
in a systematic and orderly manner in the form of written policies and
procedures such as quality programmes, quality plans, quality manuals and
quality records.
It shall include in particular 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
design and of product, including control of products which fail to
conform;1993L0042 — EN — 20.11.2003 — 004.001 — 27
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(c) the procedures for monitoring and verifying the design of the products
and in particular:
— a general description of the product, including any variants planned,
— the design specifications, including the standards which will be
applied and the results of the risk analysis, and also a description
of the solutions adopted to fulfil the essential requirements which
apply to the products if the standards referred to in Article 5 are
not applied in full,
— the techniques used to control and verify the design and the
processes and systematic measures which will be used when the
products are being designed,
— if the device is to be connected to other device(s) in order to
operate as intended, proof must be provided that it conforms to the
essential requirements when connected to any such device(s) having
the characteristics specified by the manufacturer,
— a statement indicating whether or not the device incorporates, as an
integral part, a substance or a human blood derivative referred to in
section 7.4 of Annex I and the data on the tests conducted in this
connection required to assess the safety, quality and usefulness of
that substance or human blood derivative, taking account of the
intended purpose of the device,
— the clinical data referred to in Annex X,
— the draft label and, where appropriate, instructions for use;
(d) the inspection and quality assurance techniques at the manufacturing
stage and in particular:
— the processes and procedures which will be used, particularly as
regards sterilization, purchasing and the relevant documents,
— the 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 carried out before, during
and after manufacture, the frequency with which they will take place,
and the test equipment used; it must be possible to trace back the cali-
bration of the test equipment adequately.
3.3. The notified body must audit the quality system to determine whether it
meets the requirements referred to in Section 3.2. It must presume that
quality systems which implement the relevant harmonized standards
conform to these requirements.
The assessment team must include at least one number with past experience
of assessments of the technology concerned. The assessment procedure
must include an inspection on the manufacturer's premises and, in duly
substantiated cases, on the premises of the manufacturer's suppliers and/or
subcontractors to inspect the manufacturing processes.
The decision is notified to the manufacturer. It must contain the conclu-
sions of the inspection and a reasoned assessment.
3.4. The manufacturer must inform the notified body which approved the
quality system of any plan for substantial changes to the quality system or
the product-range covered. The notified body must assess the changes
proposed and verify whether after these changes the quality system still
meets the requirements referred to in Section 3.2. It must notify the manu-
facturer of its decision. This decision must contain the conclusions of the
inspection and a reasoned assessment.
4.Examinationofthedesignoftheproduct
4.1. In addition to the obligations imposed by Section 3, the manufacturer must
lodge with the notified body an application for examination of the design
dossier relating to the product which he plans to manufacture and which
falls into the category referred to in Section 3.1.
4.2. The application must describe the design, manufacture and performances of
the product in question. It must include the documents needed to assess
whether the product conforms to the requirements of this Directive, as
referred to in Section 3.2 (c).
4.3. The notified body must examine the application and, if the product
conforms to the relevant provisions of this Directive, issue the application
with an EC design-examination certificate. The notified body may require
the application to be completed by further tests or proof to allow assess-
ment of conformity with the requirements of the Directive. The certificate1993L0042 — EN — 20.11.2003 — 004.001 — 28
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must contain the conclusions of the examination, the conditions of validity,
the data needed for identification of the approved design, where appro-
priate, a description of the intended purpose of the product.
In the case of devices referred to in Annex I, section 7.4, first subpara-
graph, the notified body shall, as regards the aspects referred to in that
section, consult one of the competent bodies designated by the Member
States in accordance with Directive 65/65/EEC before taking a decision.
The notified body will give due consideration to the views expressed in
this consultation when making its decision. It will convey its final decision
to the competent body concerned.
In the case of devices referred to in Annex I, section 7.4, second subpara-
graph, the scientific opinion of the EMEA must be included in the
documentation concerning the device. The notified body will give due
consideration to the opinion of the EMEA when making its decision. The
notified body may not deliver the certificate if the EMEA's scientific
opinion is unfavourable. It will convey its final decision to the EMEA.
4.4. Changes to the approved design must receive further approval from the
notified body which issued the EC design-examination certificate wherever
the changes could affect conformity with the essential requirements of the
Directive or with the conditions prescribed for use of the product. The
applicant shall inform the notified body which issued the EC design-exam-
ination certificate of any such changes made to the approved design. This
additional approval must take the form of a supplement to the EC design-
examination certificate.
5.Surveillance
5.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the
obligations imposed by the approved quality system.
5.2. The manufacturer must authorize the notified body to carry out all the
necessary inspections and supply it with all relevant information, in parti-
cular:
— the documentation on the quality system,
— the data stipulated in the part of the quality system relating to design,
such as the results of analyses, calculation tests, etc.,
— the data stipulated in the part of the quality system relating to manufac-
ture, such as inspection reports and test data, calibration data,
qualification reports of the personnel concerned, etc.
5.3. The notified body must periodically carry out appropriate inspections and
assessments to make sure that the manufacturer applies the approved
quality system and must supply the manufacturer with an assessment
report.
5.4. In addition, the notified body may pay unannounced visits to the manufac-
turer. At the time of such visits, the notified body may, where necessary,
carry out or ask for tests in order to check that the quality system is
working properly. It must provide the manufacturer with an inspection
report and, if a test has been carried out, with a test report.
6.Administrativeprovisions
6.1. The manufacturer must, for a period ending at least five years after the last
product has been manufactured, keep at the disposal of the national autho-
rities:
— the declaration of conformity,
— the documentation referred to in the fourth indent of Section 3.1,
— the changes referred to in Section 3.4,
— the documentation referred to in Section 4.2, and— the decisions and reports from the notified body as referred to in
Sections 3.3, 4.3, 4.4, 5.3 and 5.4.
6.3. In respect of devices subject to the procedure in Section 4, when neither the
manufacturer nor his authorized representative is established in the
Community, the obligation to keepavailable the technical documentation
shall fall to the person responsible for placing the device on the Commu-
nity market or the importer referred to in Annex I, Section 13.3 (a).1993L0042 — EN — 20.11.2003 — 004.001 — 29
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7.ApplicationtodevicesinClassesIIaandIIb
In line with Article 11 (2) and (3), this Annex may apply to products in
Classes IIa and IIb. Section 4, however, does not apply.
8.Applicationtothedevicesreferred toArticle1(4a)
Upon completing the manufacture of each batch of devices referred to in
Article 1(4a), the manufacturer shall inform the notified body of the release
of the batch of devices and send to it the official certificate concerning the
release of the batch of human blood derivative used in the device, issued by
a State laboratory or a laboratory designated for that purpose by a Member
State in accordance with Article 4(3) of Directive 89/381/EEC.1993L0042 — EN — 20.11.2003 — 004.001 — 30
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ANNEX III
ECTYPE-EXAMINATION
1. EC type-examination is the procedure whereby a notified body ascertains
and certifies that a representative sample of the production covered fulfils
the relevant provisions of this Directive.
2. The application includes:
— the name and address of the manufacturer and the name and address of
the authorized representative if the application is lodged by the repre-
sentative,
— the documentation described in Section 3 needed to assess the confor-
mity of the representative sample of the production in question,
hereinafter referred to as the ‘type’, with the requirements of this Direc-
tive. The applicant must make a ‘type’ available to the notified body.
The notified body may request other samples as necessary,
— a written declaration that no application has been lodged with any other
notified body for the same type.
3. The documentation must allow an understanding of the design, the manu-
facture and the performances of the product and must contain the following
items in particular:
— a general description of the type, including any variants planned,
— design drawings, methods of manufacture envisaged, in particular as
regards sterilization, and diagrams of components, sub-assemblies,
circuits, etc.,
— the descriptions and explanations necessary to understand the above-
mentioned drawings and diagrams and the operation of the product,
— a list of the standards referred to in Article 5, applied in full or in part,
and descriptions of the solutions adopted to meet the essential require-
ments if the standards referred to in Article 5 have not been applied in
full,
— the results of the design calculations, risk analysis, investigations, tech-
nical tests, etc. carried out,
— a declaration stating whether or not the device incorporates, as an inte-
gral part, a substance or human blood derivative, referred to in section
7.4 of Annex I, and the data on the tests conducted in this connection
which are required to assess the safety, quality and usefulness of that
substance or human blood derivative, taking account of the intended
purpose of the device,
— the clinical data referred to in Annex X,
— the draft label and, where appropriate, instructions for use.
4. The notified body must:
4.1. examine and assess the documentation and verify that the type has been
manufactured in conformity with that documentation; it must also record
the items designed in conformity with the applicable provisions of the stan-
dards referred to in Article 5, as well as the items not designed on the basis
of the relevant provisions of the abovementioned standards;
4.2. carry out or arrange for the appropriate inspections and the tests necessary
to verify whether the solutions adopted by the manufacturer meet the essen-
tial requirements of this Directive if the standards referred to in Article 5
have not been applied; if the device is to be connected to other device(s)
in order to operate as intended, proof must be provided that it conforms to
the essential requirements when connected to any such device(s) having the
characteristics specified by the manufacturer;
4.3. carry out or arrange for the appropriate inspections and the tests necessary
to verify whether, if the manufacturer has chosen to apply the relevant stan-
dards, these have actually been applied;
4.4. agree with the applicant on the place where the necessary inspections and
tests will be caried out.
5. If the type conforms to the provisions of this Directive, the notified body
issues the applicant with an EC type-examination certificate. The certificate
must contain the name and address of the manufacturer, the conclusions of
the inspection, the conditions of validity and the data needed for identifica-
tion of the type approved. The relevant parts of the documentation must be
annexed to the certificate and a copy kept by the notified body.1993L0042 — EN — 20.11.2003 — 004.001 — 31
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In the case of devices referred to in Annex I, section 7.4, first subpara-
graph, the notified body shall, as regards the aspects referred to in that
section, consult one of the competent bodies designated by the Member
States in accordance with Directive 65/65/EEC before taking a decision.
The notified body will give due consideration to the views expressed in
this consultation when making its decision. It will convey its final decision
to the competent body concerned.
In the case of devices referred to in Annex I, section 7.4, second subpara-
graph, the scientific opinion of the EMEA must be included in the
documentation concerning the device. The notified body will give due
consideration to the opinion of the EMEA when making its decision. The
notified body may not deliver the certificate if the EMEA's scientific
opinion is unfavourable. It will convey its final decision to the EMEA.
6. The applicant must inform the notified body which issued the EC type-
examination certificate of any significant change made to the approved
product.
Changes to the approved product must receive further approval from the
notified body which issued the EC type-examination certificate wherever
the changes may affect conformity with the essential requirements or with
the conditions prescribed for use of the product. This new approval must,
where appropriate, take the form of a supplement to the initial EC type-
examination certificate.
7.Administrativeprovisions
7.2. Other notified bodies may obtain a copy of the EC type-examination certi-
ficates and/or the supplements thereto. The Annexes to the certificates must
be made available to other notified bodies on reasoned application, after the
manufacturer has been informed.
7.3. The manufacturer or his authorized representative must keep with the tech-
nical documentation copies of EC type-examination certificates and their
additions for a period ending at least five years after the last device has
been manufactured.
7.4. When neither the manufacturer nor his authorized representative is estab-
lished in the Community, the obligation to keepavailable the technical
documentation shall fall to the person responsible for placing the device
on the Community market or the importer referred to in Annex I, Section
13.3 (a).1993L0042 — EN — 20.11.2003 — 004.001 — 32
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ANNEX IV
ECVERIFICATION
1. EC verification is the procedure whereby the manufacturer or his author-
ized representative established in the Community ensures and declares that
the products which have been subject to the procedure set out in Section 4
conform to the type described in the EC type-examination certificate and
meet the requirements of this Directive which apply to them.
2. The manufacturer must take all the measures necessary to ensure that the
manufacturing process produces products which conform to the type
described in the EC type-examination certificate and to the requirements
of the Directive which apply to them. Before the start of manufacture, the
manufacturer must prepare documents defining the manufacturing process,
in particular as regards sterilization where necessary, together with all the
routine, pre-established provisions to be implemented to ensure homoge-
neous production and, where appropriate, conformity of the products with
the type described in the EC type-examination certificate and with the
requirements of this Directive which apply to them. The manufacturer
must affix the CE marking in accordance with Article 17 and draw upa
declaration of conformity.
In addition, for products placed on the market in sterile condition, and only
for those aspects of the manufacturing process designed to secure and
maintain sterility, the manufacturer must apply the provisions of Annex V,
Sections 3 and 4.
3. The manufacturer must undertake to institute and keepupto date a
systematic procedure to review experience gained from devices in the
post-production phase and to implement appropriate means to apply any
necessary corrective action. This undertaking must include an obligation
for the manufacturer to notify the competent authorities of the following
incidents immediately on learning of them:
(i) any malfunction or deterioration in the characteristics and/or perfor-
mance of a device, as well as any inadequacy in the labelling or the
instructions for use which might lead to or might have led to the death
of a patient or user or to a serious deterioration in his state of health;
(ii) any technical or medical reason connected with the characteristics or
performance of a device for the reasons referred to in subparagraph
(i) leading to systematic recall of devices of the same type by the
manufacturer.
4. The notified body must carry out the appropriate examinations and tests in
order to verify the conformity of the product with the requirements of the
Directive either by examining and testing every product as specified in
Section 5 or by examining and testing products on a statistical basis as
specified in Section 6, as the manufacturer decides.
The aforementioned checks do not apply to those aspects of the manufac-
turing process designed to secure sterility.
5.Verificationbyexaminationandtestingofeveryproduct
5.1. Every product is examined individually and the appropriate tests defined in
the relevant standard(s) referred to in Article 5 or equivalent tests must be
carried out in order to verify, where appropriate, the conformity of the
products with the EC type described in the type-examination certificate
and with the requirements of the Directive which apply to them.
5.2. The notified body must affix, or have affixed its identification number to
each approved product and must draw up a written certificate of conformity
relating to the tests carried out.
6.Statisticalverification
6.1. The manufacturer must present the manufactured products in the form of
homogeneous batches.
6.2. A random sample is taken from each batch. The products which make up
the sample are examined individually and the appropriate tests defined in
the relevant standard(s) referred to in Article 5 or equivalent tests must be
carried out to verify, where appropriate, the conformity of the products
with the type described in the EC type-examination certificate and with
the requirements of the Directive which apply to them in order to deter-
mine whether to accept or reject the batch.1993L0042 — EN — 20.11.2003 — 004.001 — 33
▼B
6.3. Statistical control of products will be based on attributes, entailing a
sampling system ensuring a limit quality corresponding to a probability of
acceptance of 5 %, with a non-conformity percentage of between3 and 7 %.
The sampling method will be established by the harmonized standards
referred to in Article 5, taking account of the specific nature of the product
categories in question.
6.4. If the batch is accepted, the notified body affixes or has affixed its identi-
fication number to each product and draws up a written certificate of
conformity relating to the tests carried out. All products in the batch may
be put on the market except any in the sample which failed to conform.
If a batch is rejected, the competent notified body must take appropriate
measures to prevent the batch from being placed on the market. In the
event of frequent rejection of batches, the notified body may suspend the
statistical verification.
The manufacturer may, on the responsibility of the notified body, affix the
notified body's identification number during the manufacturing process.
7.Administrativeprovisions
The manufacturer or his authorized representative must, for a period ending
at least five years after the last product has been manufactured, make avail-
able to the national authorities:
— the declaration of conformity,
— the documentation referred to in Section 2,
— the certificates referred to in Sections 5.2 and 6.4,— where appropriate, the type-examination certificate referred to in Annex
III.
8.ApplicationtodevicesinClassIIa
In line with Article 11 (2), this Annex may apply to products in Class IIa,
subject to the following exemptions:
8.1. in derogation from Sections 1 and 2, by virtue of the declaration of confor-
mity the manufacturer ensures and declares that the products in Class IIa
are manufactured in conformity with the technical documentation referred
to in Section 3 of Annex VII and meet the requirements of this Directive
which apply to them;
8.2. in derogation from Sections 1, 2, 5 and 6, the verifications conducted by
the notified body are intended to confirm the conformity of the products
in Class IIa with the technical documentation referred to in Section 3 of
Annex VII.
9.Applicationtodevicesreferred toinArticle1(4a)
In the case of section 5, upon completing the manufacture of each batch of
devices referred to in Article 1(4a), and in the case of verification under
section 6, the manufacturer shall inform the notified body of the release
of this batch of devices and send to it the official certificate concerning
the release of the batch of human blood derivative used in the device issued
by a State laboratory or a laboratory designated for that purpose by a
Member State in accordance with Article 4(3) of Directive 89/381/EEC.1993L0042 — EN — 20.11.2003 — 004.001 — 34
▼M2
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ANNEX V
ECDECLARATIONOFCONFORMITY
(Productionqualityassurance)
1. The manufacturer must ensure application of the quality system approved
for the manufacture of the products concerned and carry out the final
inspection, as specified in Section 3, and is subject to the Community
surveillance referred to in Section 4.
2. The declaration of conformity is the part of the procedure whereby the
manufacturer who fulfils the obligations imposed by Section 1 ensures and
declares that the products concerned conform to the type described in the
EC type-examination certificate and meets the provisions of this Directive
which apply to them.
The manufacturer must affix the CE marking in accordance with Article 17
and draw upa written declaration of conformity. This declaration must
cover a given number of identified specimens of the products manufactured
and must be kept by the manufacturer.
3.Qualitysystem
3.1. The manufacturer must lodge an application for assessment of his quality
system with a notified body.
The application must include:
— the name and address of the manufacturer,
— all the relevant information on the product or product category covered
by the procedure,
— a written declaration that no application has been lodged with any other
notified body for the same products,
— the documentation on the quality system,— an undertaking to fulfil the obligations imposed by the quality system is
approved,
— an undertaking to maintain the practicability and effectiveness of the
approved quality system,
— where appropriate, the technical documentation on the types approved
and a copy of the EC type-examination certificates,
— an undertaking by the manufacturer to institute and keepupto date a
systematic procedure to review experience gained from devices in the
post-production phase and to implement appropriate means to apply
any necessary corrective action. This undertaking must include an obli-
gation for the manufacturer to notify the competent authorities of the
following incidents immediately on learning of them:
(i) any malfunction or deterioration in the characteristics and/or perfor-
mance of a device, as well as any inadequacy in the labelling or the
instructions for use which might lead to or might have led to the
death of a patient or user or to a serious deterioration in his state
of health;
(ii) any technical or medical reason connected with the characteristics
or performance of a device for the reasons referred to in subpara-
graph (i) above leading to a systematic recall of devices of the
same type 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 must be documented in a systematic and orderly
manner in the form of written policy statements and procedures. This
quality system documentation must permit uniform interpretation of the
quality policy and procedures such as quality programmes, plans, manuals
and records.
It must include in particular an adequate description of:
(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,1993L0042 — EN — 20.11.2003 — 004.001 — 35
▼B
— the methods of monitoring the efficient operation of the quality
system and in particular its ability to achieve the desired quality of
product, including control of products which fail to conform;
(c) the inspection and quality assurance techniques at the manufacturing
stage and in particular:
— the processes and procedures which will be used, particularly as
regards sterilization, purchasing and the relevant documents,
— the 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 to be carried out before, during and after
manufacture, the frequency with which they will take place, and thetest equipment used; it must be possible adequately to trace back the
calibration of the test equipment.
3.3. The notified body must audit the quality system to determine whether it
meets the requirements referred to in Section 3.2. It must presume that
quality systems which implement the relevant harmonized standards
conform to these requirements.
The assessment team must include at least one member with past experi-
ence of assessments of the technology concerned. The assessment
procedure must include an inspection on the manufacturer's premises and,
in duly substantiated cases, on the premises of the manufacturer's suppliers
to inspect the manufacturing processes.
The decision must be notified to the manufacturer after the final inspection
and contain the conclusions of the inspection and a reasoned assessment.
3.4. The manufacturer must inform the notified body which approved the
quality system of any plan for substantial changes to the quality system.
The notified body must assess the changes proposed and verify whether
after these changes the quality system still meets the requirements referred
to in Section 3.2.
After the abovementioned information has been received the decision is
notified to the manufacturer. It must contain the conclusions of the inspec-
tion and a reasoned assessment.
4.Surveillance
4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the
obligations imposed by the approved quality system.
4.2. The manufacturer authorizes the notified body to carry out all the necessary
inspections and must supply it with all relevant information, in particular:
— the documentation on the quality system,
— the data stipulated in the part of the quality system relating to manufac-
ture, such as inspection reports and test data, calibration data,
qualification reports of the personnel concerned, etc.
4.3. The notified body must periodically carry out appropriate inspections and
assessments to make sure that the manufacturer applies the approved
quality system and supply the manufacturer with an assessment report.
4.4. In addition, the notified body may pay unannounced visits to the manufac-
turer. At the time of such visits, the notified body may, where necessary,
carry out or ask for tests in order to check that the quality system is
working properly. It must provide the manufacturer with an inspection
report and, if a test has been carried out, with a test report.
5.Administrativeprovisions
5.1. The manufacturer must, for a period ending at least five years after the last
product has been manufactured, make available to the national authorities:
— the declaration of conformity,
— the documentation referred to in the fourth indent of Section 3.1,— the changes referred to in Section 3.4,— the documentation referred to in the seventh indent of Section 3.1,— the decisions and reports from the notified body as referred to in
Sections 4.3 and 4.4,
— where appropriate, the type-examination certificate referred to in Annex
III.1993L0042 — EN — 20.11.2003 — 004.001 — 36
▼M1
6.ApplicationtodevicesinClassIIa
In line with Article 11 (2), this Annex may apply to products in Class IIa,
subject to the following exemption:
6.1. in derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of
conformity the manufacturer ensures and declares that the products in Class
IIa are manufactured in conformity with the technical documentation
referred to in Section 3 of Annex VII and meet the requirements of this
Directive which apply to them.
7.Applicationtodevicesreferred toinArticle1(4a)
Upon completing the manufacture of each batch of devices referred to in
Article 1(4a), the manufacturer shall inform the notified body of the release
of the batch of devices and send to it the official certificate concerning the
release of the batch of human blood derivative used in the device issued by
a State laboratory or a laboratory designated for that purpose by a Member
State in accordance with Article 4(3) of Directive 89/381/EEC.1993L0042 — EN — 20.11.2003 — 004.001 — 37
▼B
▼M2
▼B
ANNEX VI
ECDECLARATIONOFCONFORMITY
(Productqualityassurance)
1. The manufacturer must ensure application of the quality system approved
for the final inspection and testing of the product, as specified in Section
3 and must be subject to the surveillance referred to in Section 4.
In addition, for products placed on the market in sterile condition, and only
for those aspects of the manufacturing process designed to secure and
maintain sterility, the manufacturer must apply the provisions of Annex V,
Sections 3 and 4.
2. The declaration of conformity is the part of the procedure whereby the
manufacturer who fulfils the obligations imposed by Section 1 ensures and
declares that the products concerned conform to the type described in the
EC type-examination certificate and meet the provisions of this Directive
which apply to them.
The manufacturer affixes the CE marking in accordance with Article 17
and draws upa written declaration of conformity. This declaration must
cover a given number of identified specimens of the products manufactured
and be kept by the manufacturer. The CE marking must be accompanied by
the identification number of the notified body which performs the tasks
referred to in this Annex.
3.Qualitysystem
3.1. The manufacturer lodges an application for assessment of his quality
system with a notified body.
The application must include:
— the name and address of the manufacturer,
— all the relevant information on the product or product category covered
by the procedure,
— a written declaration specifying that no application has been lodged
with any other notified body for the same products,
— the documentation on the quality system,— an undertaking by the manufacturer to fulfil the obligations imposed by
the quality system approved,
— an undertaking by the manufacturer to keep the approved quality
system adequate and efficacious,
— where appropriate, the technical documentation on the types approved
and a copy of the EC type-examination certificates,
— an undertaking by the manufacturer to institute and keepupto date a
systematic procedure to review experience gained from devices in the
post-production phase and to implement appropriate means to apply
any necessary corrective action. This undertaking must include an obli-
gation for the manufacturer to notify the competent authorities of the
following incidents immediately on learning of them:
(i) any malfunction or deterioration in the characteristics and/or perfor-
mance of a device, as well as any inadequacy in the labelling or the
instructions for use which might lead to or might have led to the
death of a patient or user or to a serious deterioration in his state
of health;
(ii) any technical or medical reason connected with the characteristics
or the performance of a device for the reasons referred to in subpar-
agraph (i) leading to a systematic recall of devices of the same type
by the manufacturer.
3.2. Under the quality system, each product or a representative sample of each
batch is examined and the appropriate tests defined in the relevant stan-
dard(s) referred to in Article 5 or equivalent tests are carried out to ensure
that the products conform to the type described in the EC type-examination
certificate and fulfil the provisions of this Directive which apply to them.
All the elements, requirements and provisionsadopted by the manufacturer
must be documented in a systematic and orderly manner in the form of
written measures, procedures and instructions. This quality system docu-
mentation must permit uniform interpretation of the quality programmes,
quality plans, quality manuals and quality records.1993L0042 — EN — 20.11.2003 — 004.001 — 38
▼B
It must include in particular an adequate description of:
— the quality objectives and the organizational structure, responsibilities
and powers of the managerial staff with regard to product quality,
— the examinations and tests that will be carried out after manufacture; it
must be possible to trace back the calibration of the test equipment
adequately,
— the methods of monitoring the efficient operation of the quality system— the quality records, such as reports concerning inspections, tests, cali-
bration and the qualifications of the staff concerned, etc.
The aforementioned checks do not apply to those aspects of the manufac-
turing process designed to secure sterility.
3.3. The notified body audits the quality system to determine whether it meets
the requirements referred to in section 3.2. It must presume that quality
systems which implement the relevant harmonized standards conform to
these requirements.
The assessment team must include at least one member with past experi-
ence of assessments of the technology concerned. The assessment
procedure must include an inspection on the manufacturer's premises and,
in duly substantiated cases, on the premises of the manufacturer's suppliers
to inspect the manufacturing processes.
The decision must be notified to the manufacturer. It must contain the
conclusions of the inspection and a reasoned assessment.
3.4. The manufacturer must inform the notified body which approved the
quality system of any plan for substantial changes to the quality system.
The notified body must assess the changes proposed and verify whether
after these changes the quality system will still meet the requirements
referred to in Section 3.2.
After receiving the abovementioned information it must notify the manu-
facturer of its decision. This decision must contain the conclusions of the
inspection and a reasoned assessment.
4.Surveillance
4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the
obligations imposed by the approved quality system.
4.2. The manufacturer must allow the notified body access for inspection
purposes to the inspection, testing and storage locations and supply it with
all relevant information, in particular:
— the documentation on the quality system,
— the technical documentation,
— the quality records, such as inspection reports, test data, calibration
data, qualification reports of the staff concerned, etc.
4.3. The notified body must periodically carry out appropriate inspections and
assessments to make sure that the manufacturer applies the quality system
and must supply the manufacturer with an assessment report.
4.4. In addition, the notified body may pay unannounced visits to the manufac-
turer. At the time of such visits, the notified body may, where necessary,
carry out or ask for tests in order to check that the quality system is
working properly and that the production conforms to the requirements of
the Directive which apply to it. To this end, an adequate sample of the final
products, taken on site by the notified body, must be examined and the
appropriate tests defined in the relevant standard(s) referred to in Article 5
or equivalent tests must be carried out. Where one or more of the samples
fails to conform, the notified body must take the appropriate measures.
It must provide the manufacturer with an inspection report and, if a test has
been carried out, with a test report.
5.Administrativeprovisions
5.1. The manufacturer must, for a period ending at least five years after the last
product has been manufactured, make available to the national authorities:
— the declaration of conformity,
— the documentation referred to in the seventh indent of Section 3.1,
— the changes referred to in Section 3.4,
— the decisions and reports from the notified body as referred to in the
final indent of Section 3.4 and in Sections 4.3 and 4.4,
— where appropriate, the certificate of conformity referred to in Annex III.1993L0042 — EN — 20.11.2003 — 004.001 — 39
▼M1
6.ApplicationtodevicesinClassIIa
In line with Article 11 (2), this Annex may apply to products in Class IIa,
subject to this derogation:
6.1. by derogation from Sections 2, 3.1 and 3.2 by virtue of the declaration of
conformity the manufacturer ensures and declares that the products in Class
IIa are manufactured in conformity with the technical documentation
referred to in Section 3 of Annex VII and meet the requirements of this
Directive which apply to them.1993L0042 — EN — 20.11.2003 — 004.001 — 40
▼B
▼B
ANNEX VII
ECDECLARATIONOFCONFORMITY
1. The EC declaration of conformity is the procedure whereby the manufac-
turer or his authorized representative established in the Community who
fulfils the obligations imposed by Section 2 and, in the case of products
placed on the market in a sterile condition and devices with a measuring
function, the obligations imposed by Section 5 ensures and declares that
the products concerned meet the provisions of this Directive which applyto them.
2. The manufacturer must prepare the technical documentation described in
Section 3. The manufacturer or his authorized representative established in
the Community must make this documentation, including the declaration of
conformity, available to the national authorities for inspection purposes for
a period ending at least five years after the last product has been manufac-
tured.
Where neither the manufacturer nor his authorized representative are estab-
lished in the Community, this obligation to keepthe technical
documentation available must fall to the person(s) who place(s) the product
on the Community market.
3. The technical documentation must allow assessment of the conformity of
the product with the requirements of the Directive. It must include in parti-
cular:
— a general description of the product, including any variants planned,
— design drawings, methods of manufacture envisaged and diagrams of
components, sub-assemblies, circuits, etc.,
— the descriptions and explanations necessary to understand the above-
mentioned drawings and diagrams and the operations of the product,
— the results of the risk analysis and a list of the standards referred to in
Article 5, applied in full or in part, and descriptions of the solutions
adopted to meet the essential requirements of the Directive if the stan-
dards referred to in Article 5 have not been applied in full,
— in the case of products placed on the market in a sterile condition,
description of the methods used,
— the results of the design calculations and of the inspections carried out,
etc.; if the device is to be connected to other device(s) in order to
operate as intended, proof must be provided that it conforms to the
essential requirements when connected to any such device(s) having
the characteristics specified by the manufacturer,
— the test reports and, where appropriate, clinical data in accordance with
Annex X,
— the label and instructions for use.
4. The manufacturer shall institute and keepupto date a systematic p rocedure
to review experience gained from devices in the post-production phase and
to implement appropriate means to apply any necessary corrective actions,
taking account of the nature and risks in relation to the product. He shall
notify the competent authorities of the following incidents immediately on
learning of them:
(i) any malfunction or deterioration in the characteristics and/or perfor-
mance of a device, as well as any inadequacy in the labelling or the
instructions for use which might lead to or might have led to the death
of a patient or user or to a serious deterioration in his state of health;
(ii) any technical or medical reason connected with the characteristics on
the performance of a device for the reasons referred to in subparagraph
(i) leading to systematic recall of devices of the same type by the
manufacturer.
5. With products placed on the market in sterile condition and Class I devices
with a measuring function, the manufacturer must observe not only the
provisions laid down in this Annex but also one of the procedures referred
to in Annex IV, V or VI. Application of the abovementioned Annexes and
the intervention by the notified body is limited to:
— in the case of products placed on the market in sterile condition, only
the aspects of manufacture concerned with securing and maintaining
sterile conditions,
— in the case of devices with a measuring function, only the aspects of
manufacture concerned with the conformity of the products with the
metrological requirements.
Section 6.1. of this Annex is applicable.1993L0042 — EN — 20.11.2003 — 004.001 — 41
▼B
6.ApplicationtodevicesinClassIIa
In line with Article 11 (2), this Annex may apply to products in Class IIa,
subject to the following derogation:
6.1. where this Annex is applied in conjunction with the procedure referred to
in Annex IV, V or VI, the declaration of conformity referred to in theabovementioned Annexes forms a single declaration. As regards the
declaration based on this Annex, the manufacturer must ensure and declare
that the product design meets the provisions of this Directive which apply
to it.1993L0042 — EN — 20.11.2003 — 004.001 — 42
▼B
ANNEX VIII
STATEMENTCONCERNINGDEVICESFORSPECIALPURPOSES
1. For custom-made devices or for devices intended for clinical investigations
the manufacturer or his authorized representative established in the
Community must draw upthe statement containing the information stip u-
lated in Section 2.
2. The statement must contain the following information:2.1. for custom-made devices:
— data allowing identification of the device in question,
— a statement that the device is intended for exclusive use by a particular
patient, together with the name of the patient,
— the name of the medical practitioner or other authorized person who
made out the prescription and, where applicable, the name of the clinic
concerned,
— the particular features of the device as specified in the relevant medical
prescription,
— a statement that the device in question conforms to the essential
requirements set out in Annex I and, where applicable, indicating which
essential requirements have not been fully met, together with the
grounds;
2.2. for devices intended for the clinical investigations covered by Annex X:
— data allowing identification of the device in question,
— an investigation plan stating in particular the purpose, scientific, tech-
nical or medical grounds, scope and number of devices concerned,
— the opinion of the ethics committee concerned and details of the aspects
covered by its opinion,
— the name of the medical practitioner or other authorized person and of
the institution responsible for the investigations,
— the place, starting date and scheduled duration for the investigations,
— a statement that the device in question conforms to the essential
requirements apart from the aspects covered by the investigations and
that, with regard to these aspects, every precaution has been taken to
protect the health and safety of the patient.
3. The manufacturer must also undertake to keepavailable for the comp etent
national authorities:
3.1. for custom-made devices, documentation allowing an understanding of the
design, manufacture and performances of the product, including the
expected performances, so as to allow assessment of conformity with the
requirements of this Directive.
The manufacturer must take all the measures necessary to ensure that the
manufacturing process produces products which are manufactured in accor-
dance with the documentation mentioned in the first paragraph;
3.2. for devices intended for clinical investigations, the documentation must
contain:
— a general description of the product,
— design drawings, methods of manufacture envisaged, in particular as
regards sterilization, and diagrams of components, sub-assemblies,
circuits, etc.,
— the descriptions and explanations necessary to understand the above-
mentioned drawings and diagrams and the operation of the product,
— the results of the risk analysis and a list of the standards referred to in
Article 5, applied in full or in part, and descriptions of the solutions
adopted to meet the essential requirements of this Directive if the stan-
dards referred to in Article 5 have not been applied,
— the results of the design calculations, and of the inspections and tech-
nical tests carried out, etc.
The manufacturer must take all the measures necessary to ensure that the
manufacturing process produces products which are manufactured in accor-
dance with the documentation referred to in the first paragraph of this
Section.
The manufacturer must authorize the assessment, or audit where necessary,
of the effectiveness of these measures.1993L0042 — EN — 20.11.2003 — 004.001 — 43
▼B
4. The information contained in the declarations concerned by this Annex
should be kept for a period of time of at least five years.1993L0042 — EN — 20.11.2003 — 004.001 — 44
▼B
ANNEX IX
CLASSIFICATIONCRITERIA
I. DEFINITIONS
1.Definitionsfortheclassificationrules
1.1.Duration
Transient
Normally intended for continuous use for less than 60 minutes.Short term
Normally intended for continuous use for not more than 30 days.
Long term
Normally intended for continuous use for more than 30 days.
1.2.Invasive devices
Invasive device
A device which, in whole or in part, penetrates inside the body, either
through a body orifice or through the surface of the body.
Body orificeAny natural opening in the body, as well as the external surface of the
eyeball, or any permanent artificial opening, such as a stoma.
Surgically invasive device
An invasive device which penetrates inside the body through the surface of
the body, with the aid or in the context of a surgical operation.
For the purposes of this Directive devices other than those referred to in the
previous subparagraph and which produce penetration other than through
an established body orifice, shall be treated as surgically invasive devices.
Implantable device
Any device which is intended:
— to be totally introduced into the human body or,
— to replace an epithelial surface or the surface of the eye,
by surgical intervention which is intended to remain in place after the
procedure.
Any device intended to be partially introduced into the human body
through surgical intervention and intended to remain in place after the
procedure for at least 30 days is also considered an implantable device.
1.3.Reusable surgical instrument
Instrument intended for surgical use by cutting, drilling, sawing, scratching,
scraping, clamping, retracting, clipping or similar procedures, without
connection to any active medical device and which can be reused after
appropriate procedures have been carried out.
1.4.Active medical device
Any medical device operation of which depends on a source of electrical
energy or any source of power other than that directly generated by the
human body or gravity and which acts by converting this energy. Medical
devices intended to transmit energy, substances or other elements between
an active medical device and the patient, without any significant change,
are not considered to be active medical devices.
1.5.Active therapeutical device
Any active medical device, whether used alone or in combination with
other medical devices, to support, modify, replace or restore biological
functions or structures with a view to treatment or alleviation of an illness,
injury or handicap.
1.6.Active device for diagnosis
Any active medical device, whether used alone or in combination with
other medical devices, to supply information for detecting, diagnosing,1993L0042 — EN — 20.11.2003 — 004.001 — 45
▼B
monitoring or treating physiological conditions, states of health, illnesses or
congenital deformities.
1.7.Central circulatory system
For the purposes of this Directive, ‘central circulatory system’ means the
following vessels:
arteriae pulmonales, aorta ascendens, arteriae coronariae, arteria carotis
communis, arteria carotis externa, arteria carotis interna, arteriae cere-
brales, truncus brachicephalicus, venae cordis, venae pulmonales, vena
cava superior, vena cava inferior .
1.8.Central nervous system
For the purposes of this Directive, ‘central nervous system’ means brain,
meninges and spinal cord.
II. IMPLEMENTING RULES
2.Implementingrules
2.1. Application of the classification rules shall be governed by the intended
purpose of the devices.
2.2. If the device is intended to be used in combination with another device, the
classification rules shall apply separately to each of the devices. Acces-
sories are classified in their own right separately from the device with
which they are used.
2.3. Software, which drives a device or influences the use of a device, falls
automatically in the same class.
2.4. If the device is not intended to be used solely or principally in a specific
part of the body, it must be considered and classified on the basis of the
most critical specified use.
2.5. If several rules apply to the same device, based on the performance speci-
fied for the device by the manufacturer, the strictest rules resulting in the
higher classification shall apply.
III. CLASSIFICATION
1.Non-invasivedevices
1.1.Rule 1
All non-invasive devices are in Class I, unless one of the rules set out here-
inafter applies.
1.2.Rule 2
All non-invasive devices intended for channelling or storing blood, body
liquids or tissues, liquids or gases for the purpose of eventual infusion,
administration or introduction into the body are in Class IIa:
— if they may be connected to an active medical device in Class IIa or a
higher class,
— if they are intended for use for storing or channelling blood or other
body liquids or for storing organs, parts of organs or body tissues,
in all other cases they are in Class I.
1.3.Rule 3
All non-invasive devices intended for modifying the biological or chemical
composition of blood, other body liquids or other liquids intended for infu-
sion into the body are in Class IIb, unless the treatment consists of
filtration, centrifugation or exchanges of gas, heat, in which case they are
in Class IIa.
1.4.Rule 4
All non-invasive devices which come into contact with injured skin:
— are in Class I if they are intended to be used as a mechanical barrier,
for compression or for absorption of exudates,
— are in Class IIb if they are intended to be used principally with wounds
which have breached the dermis and can only heal by secondary intent,
— are in Class IIa in all other cases, including devices principally intended
to manage the micro-environment of a wound.1993L0042 — EN — 20.11.2003 — 004.001 — 46
▼B
2.Invasivedevices
2.1.Rule 5
All invasive devices with respect to body orifices, other than surgically
invasive devices and which are not intended for connection to an active
medical device:
— are in Class I if they are intended for transient use,
— are in Class IIa if they are intended for short-term use, except if they
are used in the oral cavity as far as the pharynx, in an ear canal up to
the ear drum or in a nasal cavity, in which case they are in Class I,
— are in Class IIb if they are intended for long-term use, except if they are
used in the oral cavity as far as the pharynx, in an ear canal up to the
ear drum or in a nasal cavity and are not liable to be absorbed by the
mucous membrane, in which case they are in Class IIa.
All invasive devices with respect to body orifices, other than surgically
invasive devices, intended for connection to an active medical device in
Class IIa or a higher class, are in Class IIa.
2.2.Rule 6
All surgically invasive devices intended for transient use are in Class IIa
unless they are:
— intended specifically to diagnose, monitor or correct a defect of the
heart or of the central circulatory system through direct contact with
these parts of the body, in which case they are in Class III,
— reusable surgical instruments, in which case they are in Class I,
— intended to supply energy in the form of ionizing radiation in which
case they are in Class IIb,
— intended to have a biological effect or to be wholly or mainly absorbed
in which case they are in Class IIb,
— intended to administer medicines by means of a delivery system, if this
is done in a manner that is potentially hazardous taking account of the
mode of application, in which they are in Class IIb.
2.3.Rule 7
All surgically invasive devices intended for short-term use are in Class IIa
unless they are intended:
— either specifically to diagnose, monitor or correct a defect of the heart
or of the central circulatory system through direct contact with these
parts of the body, in which case they are in Class III,
— or specifically for use in direct contact with the central nervous system,
in which case they are in Class III,
— or to supply energy in the form of ionizing radiation in which case they
are in Class IIb,
— or to have a biological effect or to be wholly or mainly absorbed in
which case they are in Class III,
— or to undergo chemical change in the body, except if the devices are
placed in the teeth, or to administer medicines, in which case they are
in Class IIb.
2.4.Rule 8
All implantable devices and long-term surgically invasive devices are in
Class IIb unless they are intended:
— to be placed in the teeth, in which case they are in Class IIa,
— to be used in direct contact with the heart, the central circulatory
system or the central nervous system, in which case they are in Class
III,
— to have a biological effect or to be wholly or mainly absorbed, in which
case they are in Class III,
— or to undergo chemical change in the body, except if the devices are
placed in the teeth, or to administer medicines, in which case they are
in Class III.
3.Additionalrulesapplicabletoactive devices
3.1.Rule 9
All active therapeutic devices intended to administer or exchange energy
are in Class IIa unless their characteristics are such that they may admin-
ister or exchange energy to or from the human body in a potentially
hazardous way, taking account of the nature, the density and site of appli-
cation of the energy, in which case they are in Class IIb.1993L0042 — EN — 20.11.2003 — 004.001 — 47
▼B
All active devices intended to control or monitor the performance of active
therapeutic devices in Class IIb, or intended directly to influence the
performance of such devices are in Class IIb.
3.2.Rule 10
Active devices intended for diagnosis are in Class IIa:
— if they are intended to supply energy which will be absorbed by the
human body, except for devices used to illuminate the patient's body,
in the visible spectrum,
— if they are intended to image in vivodistribution of radiopharmaceuti-
cals,
— if they are intended to allow direct diagnosis or monitoring of vital
physiological processes, unless they are specifically intended for moni-
toring of vital physiological parameters, where the nature of variations
is such that it could result in immediate danger to the patient, for
instance variations in cardiac performance, respiration, activity of CNS
in which case they are in Class IIb.
Active devices intended to emit ionizing radiation and intended for diag-
nostic and therapeutic interventional radiology including devices which
control or monitor such devices, or which directly influence their perfor-
mance, are in Class IIb.
Rule 11All active devices intended to administer and/or remove medicines, body
liquids or other substances to or from the body are in Class IIa, unless
this is done in a manner:
— that is potentially hazardous, taking account of the nature of the
substances involved, of the part of the body concerned and of the
mode of application in which case they are in Class IIb.
3.3.Rule 12
All other active devices are in Class I.
4.SpecialRules
4.1.Rule 13
All devices incorporating, as an integral part, a substance which, if used
separately, can be considered to be a medicinal product, as defined in
Article 1 of Directive 65/65/EEC, and which is liable to act on the human
body with action ancillary to that of the devices, are in Class III.
All devices incorporating, as an integral part, a human blood derivative are
in Class III.
4.2.Rule 14
All devices used for contraception or the prevention of the transmission of
sexually transmitted diseases are in Class IIb, unless they are implantable
or long term invasive devices, in which case they are in Class III.
4.3.Rule 15
All devices intended specifically to be used for disinfecting, cleaning,
rinsing or, when appropriate, hydrating contact lenses are in Class IIb.
All devices intended specifically to be used for disinfecting medical
devices are in Class IIa.
This rule does not apply to products that are intended to clean medical
devices other than contact lenses by means of physical action.
4.4.Rule 16
Non-active devices specifically intended for recording of X-ray diagnostic
images are in Class IIa.
4.5.Rule 17
All devices manufactured utilizing animal tissues or derivatives rendered
non-viable are Class III except where such devices are intended to come
into contact with intact skin only.
5.Rule 18
By derogation from other rules, blood bags are in Class IIb.1993L0042 — EN — 20.11.2003 — 004.001 — 48
▼M2
▼B
▼B
ANNEX X
CLINICALEVALUATION
1.General provisions
1.1. As a general rule, confirmation of conformity with the requirements
concerning the characteristics and performances referred to in Sections 1
and 3 of Annex I under the normal conditions of use of the device and
the evaluation of the undesirable side-effects must be based on clinical
data in particular in the case of implantable devices and devices in Class
III. Taking account of any relevant harmonized standards, where appro-
priate, the adequacy of the clinical data must be based on:
1.1.1. either a compilation of the relevant scientific literature currently available
on the intended purpose of the device and the techniques employed as
well as, if appropriate, a written report containing a critical evaluation
of this compilation;
1.1.2. or the results of all the clinical investigations made, including those
carried out in conformity with Section 2.
1.2. All the data must remain confidential, in accordance with the provisions
of Article 20.
2.Clinicalinvestigations
2.1.Objectives
The objectives of clinical investigation are:
— to verify that, under normal conditions of use, the performance of the
devices conform to those referred to in Section 3 of Annex I, and
— to determine any undesirable side-effects, under normal conditions of
use, and assess whether they constitute risks when weighed against
the intended performance of the device.
2.2.Ethical considerations
Clinical investigations must be carried out in accordance with the
Helsinki Declaration adopted by the 18th World Medical Assembly in
Helsinki, Finland, in 1964, as last amended by the 41st World Medical
Assembly in Hong Kong in 1989. It is mandatory that all measures
relating to the protection of human subjects are carried out in the spirit
of the Helsinki Declaration. This includes every stepin the clinical inves-
tigation from first consideration of the need and justification of the study
to publication of the results.
2.3.Methods
2.3.1. Clinical investigations must be performed on the basis of an appropriate
plan of investigation reflecting the latest scientific and technical knowl-
edge and defined in such a way as to confirm or refute the
manufacturer's claims for the device; these investigations must include
an adequate number of observations to guarantee the scientific validity
of the conclusions.
2.3.2. The procedures used to perform the investigations must be appropriate to
the device under examination.
2.3.3. Clinical investigations must be performed in circumstances similar to the
normal conditions of use of the device.
2.3.4. All the appropriate features, including those involving the safety and
performances of the device, and its effect on patients must be examined.
2.3.5. All adverse incidents such as those specified in Article 10 must be fully
recorded and notified to the competent authority.
2.3.6. The investigations must be performed under the responsibility of a
medical practitioner or another authorized qualified person in an appro-
priate environment.
The medical practitioner or other authorized person must have access to
the technical and clinical data regarding the device.
2.3.7. The written report, signed by the medical practitioner or other authorized
person responsible, must contain a critical evaluation of all the data
collected during the clinical investigation.1993L0042 — EN — 20.11.2003 — 004.001 — 49
▼B
ANNEX XI
CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED
BODIES
1. The notified body, its Director and the assessment and verification staff shall
not be the designer, manufacturer, supplier, installer or user of the devices
which they inspect, nor the authorized representative of any of these persons.
They may not be directly involved in the design, construction, marketing or
maintenance of the devices, nor represent the parties engaged in these activ-ities. This in no way precludes the possibility of exchanges of technical
information between the manufacturer and the body.
2. The notified body and its staff must carry out the assessment and verification
operations with the highest degree of professional integrity and the requisite
competence in the field of medical devices and must be free from all pres-
sures and inducements, particularly financial, which might influence their
judgment or the results of the inspection, especially from persons or groups
of persons with an interest in the results of the verifications.
Should the notified body subcontract specific tasks connected with the estab-
lishment and verification of the facts, it must first ensure that the
subcontractor meets the provisions of the Directive and, in particular, of this
Annex. The notified body shall keepat the disp osal of the national authori-
ties the relevant documents assessing the subcontractor's qualifications and
the work carried out by the subcontractor under this Directive.
3. The notified body must be able to carry out all the tasks assigned to such
bodies by one of Annexes II to VI and for which it has been notified,
whether these tasks are carried out by the body itself or on its responsibility.
In particular, it must have the necessary staff and possess the facilities
needed to perform properly the technical and administrative tasks entailed
in assessment and verification. ►
M1This presupposes the availability of
sufficient scientific staff within the organisation who possess experience and
knowledge sufficient to assess the medical functionality and performance of
devices for which it has been notified, having regard to the requirements of
this Directive and, in particular, those set out in Annex I. ◄It must also
have access to the equipment necessary for the verifications required.
4. The notified body must have:
— sound vocational training covering all the assessment and verification
operations for which the body has been designated,
— satisfactory knowledge of the rules on the inspections which they carry
out and adequate experience of such inspections,
— the ability required to draw upthe certificates, records and rep orts to
demonstrate that the inspections have been carried out.
5. The impartiality of the notified body must be guaranteed. Their remuneration
must not depend on the number of inspections carried out, nor on the results
of the inspections.
6. The body must take out civil liability insurance, unless liability is assumed
by the State under domestic legislation or the Member State itself carries
out the inspections directly.
7. The staff of the notified body are bound to observe professional secrecy with
regard to all information gained in the course of their duties (except vis-à-vis
the competent administrative authorities of the State in which their activities
are carried out) pursuant to this Directive or any provision of national law
putting it into effect.1993L0042 — EN — 20.11.2003 — 004.001 — 50
▼B
ANNEX XII
CEMARKINGOFCONFORMITY
The CE conformity marking shall consist of the initials ‘CE’ taking the
following form:
— If the 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.1993L0042 — EN — 20.11.2003 — 004.001 — 51