1998L0079 — EN — 20.11.2003 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B DIRECTIVE98/79/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
of27October1998
onin vitrodiagnosticmedicaldevices
(OJ L 331, 7.12.1998, p. 1)
Amended by:
Official Journal
No page date
►M1Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003L 284 1 31.10.2003
Corrected by:
►C1Corrigendum, OJ L 22, 29.1.1999, p. 75 (98/79/EC)
►C2Corrigendum, OJ L 6, 10.1.2002, p. 70 (98/79/EC)
▼B
DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT
ANDOFTHECOUNCIL
of27October 1998
onin vitrodiagnosticmedicaldevices
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social
Committee (2),
Acting in accordance withth e procedure laid down in Article 189b of
the Treaty (3),
(1)Whereas measures should be adopted for the smooth operationof the internal market; whereas the internal market is an area
without internal frontiers in which the free movement of goods,persons, services and capital is ensured;
(2)Whereas the content and scope of the laws, regulations andadministrative provisions in force in the Member States withregard to the safety, health protection and performance, charac-teristics and authorisation procedures for in vitro diagnostic
medical devices are different; whereas the existence of such
disparities creates barriers to trade, and whereas the need to
establish harmonised rules has been confirmed by a comparativesurvey of national legislations carried out on behalf of theCommission;
(3)Whereas the harmonisation of national legislation is the onlymeans of removing suchbarriers to free trade and of preventingnew barriers from arising; whereas this objective cannot be
achieved in a satisfactory manner by other means by the indivi-
dual Member States; whereas this Directive lays down only suchrequirements as are necessary and sufficient to ensure, under thebest safety conditions, free movement of the in vitrodiagnostic
medical devices to which it applies;
(4)Whereas the harmonised provisions must be distinguished frommeasures adopted by the Member States to manage the fundingof public health and sickness insurance schemes relating directly
or indirectly to such devices; whereas, therefore, the harmonised
provisions do not affect the ability of the Member States toimplement such measures provided that they comply withCommunity law;
(5)Whereas in vitro diagnostic medical devices should provide
patients, users and third parties with a high level of healthprotection and attain the performance levels originally attributed
to them by the manufacturer; whereas, therefore, maintenance or
improvement of the level of health protection attained in theMember States is one of the main objectives of this Directive;
(6)Whereas, in accordance with the principles set out in the Councilresolution of 7 May 1985 on a new approach to technical harmo-nisation and standards (
4), rules regarding the design,
manufacture and packaging of relevant products must beconfined to the provisions required to meet the essential require-1998L0079 — EN — 20.11.2003 — 001.001 — 2
(1) OJ C 172, 7.7.1995, p. 21 and OJ C 87, 18.3.1997, p. 9.
(2) OJ C 18, 22.1.1996, p. 12.
(3) Opinion of the European Parliament of 12 March 1996 (OJ C 96, 1.4.1996,
p. 31), Council common position of 23 March1998 (OJ C 178, 10.6.1998,
p. 7) and Decision of the European Parliament of 18 June 1998 (OJ C 210,
6.7.1998). Council Decision of 5 October 1998.
(4) OJ C 136, 4.6.1985, p. 1.
▼B
ments; whereas, because they are essential, such requirements
should replace the corresponding national provisions; whereasthe essential requirements, including requirements to minimise
and reduce risks, should be applied with discretion, taking into
account the technology and practice at the time of design andtechnical and economic considerations compatible with a highlevel of protection of health and safety;
(7)Whereas the major part of medical devices are covered byCouncil Directive 90/385/EEC of 20 June 1990 on the approxi-mation of laws relating to active implantable medical devices (
1)
and Council Directive 93/42/EEC of 14 June 1993 concerningmedical devices (
2) withth e exclusion of in vitro diagnostic
medical devices; whereas this Directive seeks to extend the
harmonisation to in vitro diagnostic medical devices and
whereas, in the interest of uniform Community rules, this Direc-tive is based largely on the provisions of the said two Directives;
(8)Whereas instruments, apparatus, appliances, materials or other
articles, including software, which are intended to be used for
researchpurposes, with out any medical objective, are notregarded as devices for performance evaluation;
(9)Whereas, although internationally certified reference materialsand materials used for external quality assessment schemes are
not covered by this Directive, calibrators and control materials
needed by the user to establish or verify performances of devicesarein vitrodiagnostic medical devices;
(10)Whereas, having regard to the principle of subsidiarity, reagents
which are produced within health-institution laboratories for use
in that environment and are not subject to commercialtransac-
tions are not covered by this Directive;
(11)Whereas, however, devices that are manufactured and intendedto be used in a professional and commercial context for purposes
of medical analysis without being marketed are subject to this
Directive;
(12)Whereas mechanical laboratory equipment especially designedforin vitrodiagnostic examinations falls within the scope of
this Directive and whereas, therefore, in order to harmonise the
relevant directives, Directive 98/37/EC of the European Parlia-
ment and of the Council of 22 June 1998 on the approximationof the laws of the Member States relating to machinery (
3),
should be appropriately amended to bring it into line with thisDirective;
(13)Whereas this Directive should include requirements regardingthe design and manufacture of devices emitting ionizing radia-tion; whereas this Directive does not affect the application ofCouncil Directive 96/29/Euratom of 13 May 1996 laying downbasic safety standards for the protection of the health of workers
and the general public against the dangers arising from ionising
radiation (
4);
(14)Whereas, since electromagnetic compatibility aspects form anintegral part of the essential requirements of this Directive,Council Directive 89/336/EEC of 2 May 1989 on the approxima-
tion of the laws of the Member States relating to electromagnetic
compatibility (
5) does not apply;
(15)Whereas, in order to ease the task of proving conformity withthe essential requirements and to enable conformity to be veri-fied, it is desirable to have harmonised standards in respect of1998L0079 — EN — 20.11.2003 — 001.001 — 3
(1) OJ L 189, 20.7.1990, p. 17. Directive as last amended by Directive 93/68/
EEC (OJ L 220, 30.8.1993, p. 1).
(2) OJ L 169, 12.7.1993, p. 1.
(3) OJ L 207, 23.7.1998, p. 1.
(4) OJ L 159, 29.6.1996, p. 1.
(5) OJ L 139, 23.5.1989, p. 19. Directive as last amended by Directive 93/68/
EEC (OJ L 220, 30.8.1993, p. 1).
▼B
the prevention of risks associated with the design, manufacture
and packaging of medical devices; whereas such harmonisedstandards are drawn up by private-law bodies and should retain
their status as non-mandatory texts; whereas, to this end, the
European Committee for Standardisation (CEN) and theEuropean Committee for Electrotechnical Standardisation(Cenelec) are recognised as the competent bodies for the adop-tion ofharmonised standards in accordance with the general
guidelines on cooperation between the Commission and those
two bodies signed on 13 November 1984;
(16)Whereas, for the purpose of this Directive, a harmonised stan-dard is a technical specification (European standard ofharmonisation document) adopted, on a mandate from theCommission, by CEN or Cenelec or by bothof th ose bodies in
accordance withDirective 98/34/EC of th e European Parliament
and of the Council of 22 June 1998 laying down a procedure forthe provision of information in the field of technical standardsand regulations (
1), and pursuant to the abovementioned general
guidelines;
(17)Whereas, by way of exception to the general principles, the
drawing up of common technical specifications takes account of
a current practice in some Member States whereby for selecteddevices mainly used for the evaluation of the safety of bloodsupply and of organ donation, suchspecifications are adoptedby the public authorities; whereas it is appropriate that these
particular specifications should be replaced by common technical
specifications; whereas these common technical specificationscan be used for performance evaluation and reevaluation;
(18)Whereas scientific experts from various interested parties couldbe involved in the drafting of common technical specificationsand in the examination of other specific or general questions;
(19)Whereas manufacturing, as covered by this Directive, alsoincludes the packaging of the medical device, insofar as suchpackaging is related to the safety and performance aspects ofthis device;
(20)Whereas certain devices have a limited life owing to the declinein their performance over time, which is related, for example, to
the deterioriation in their physical or chemical properties,
including the sterility or integrity of the packaging; whereas themanufacturer should determine and indicate the period duringwhich the device will perform as intended; whereas the labellingshould indicate the date until which the device or one of itscomponents can be used withcomplete safety;
(21)Whereas, in Decision 93/465/EEC of 22 July 1993 concerningthe modules for the various phases of the conformity assessmentprocedures and the rules for the affixing and use of the CEconformity marking, which are intended to be used in the tech-nical harmonisation directives (
2), the Council laid down
harmonised conformity assessment procedures; whereas the
details added to these modules are justified by the nature of theverification required for in vitrodiagnostic medical devices and
by the need for consistency with Directives 90/385/EEC and 93/42/EEC;
(22)Whereas it is necessary, essentially for the purpose of the
conformity assessment procedures, to group in vitrodiagnostic
medical devices into two main product classes; whereas, sincethe large majority of such devices do not constitute a direct riskto patients and are used by competently trained professionals,and the results obtained can often be confirmed by other means,the conformity assessment procedures can be carried out, as a1998L0079 — EN — 20.11.2003 — 001.001 — 4
(1) OJ L 204, 21.7.1998, p. 37. Directive as last amended by Directive 98/48/
EC (OJ L 217, 5.8.1998, p. 18).
(2) OJ L 220, 30.8.1993, p. 23.
▼B
general rule, under the sole responsibility of the manufacturer;
whereas, taking account of existing national regulations and ofnotifications received following the procedure laid down in
Directive 98/34/EC, the intervention of notified bodies is needed
only for defined devices, the correct performance of which isessential to medical practice and the failure of which can causea serious risk to health;
(23)Whereas, among the in vitro diagnostic medical devices for
which intervention of a notified body is required, the groups of
products used in blood transfusion and the prevention of AIDS
and certain types of hepatitis require a conformity assessmentguaranteeing, witha view to th eir design and manufacture, anoptimum level of safety and reliability;
(24)Whereas the list of in vitrodiagnostic medical devices to be
subjected to third-party conformity assessment needs updating,taking account of technological progress and of developments
in the field of health protection; whereas such updating measures
must be taken in line withprocedure III(a) as laid down inCouncil Decision 87/373/EEC of 13 July 1987 laying down theprocedures for the exercise of implementing powers conferred onthe Commission (
1);
(25)Whereas an agreement on a modus vivendi between theEuropean Parliament, the Council and the Commission
concerning the implementing measures for acts adopted in accor-
dance with the procedure laid down in Article 189b of the Treatywas reached on 20 December 1994 (
2);
(26)Whereas medical devices should, as a general rule, bear the CEmarking indicating their conformity with the provisions of thisDirective to enable them to move freely within the Communityand to be put into service in accordance withth eir intended
purpose;
(27)Whereas manufacturers will be able, when the intervention of anotified body is required, to choose from a list of bodies
published by the Commission; whereas, although Member Statesdo not have an obligation to designate such notified bodies, theymust ensure that bodies designated as notified bodies complywith the assessment criteria laid down in this Directive;
(28)Whereas the director and staff of the notified bodies should not,themselves or through an intermediary, have any interest in the
establishments subject to assessment and verification which is
likely to compromise their independence;
(29)Whereas the competent authorities in charge of market surveil-lance should be able, particularly in emergencies, to contact themanufacturer or his authorised representative established in theCommunity, in order to take any protection measures that shouldprove necessary; whereas cooperation and exchange of informa-
tion between Member States are necessary witha view to
uniform application of this Directive, in particular for thepurpose of market surveillance; whereas to that end it is neces-sary to establishand manage a database containing data onmanufacturers and their authorised representatives, on devices
placed on the market, on certificates issued, suspended or with-
drawn, and on the vigilance procedure; whereas a system ofadverse incident reporting (vigilance procedure) constitutes auseful tool for surveillance of the market, including the perfor-mance of new devices; whereas information obtained from thevigilance procedure as well as from external quality assessment
schemes is useful for decision-making on classification of
devices;
(30)Whereas it is essential that manufacturers notify the competentauthorities of the placing on the market of ‘new products’ with1998L0079 — EN — 20.11.2003 — 001.001 — 5
(1) OJ L 197, 18.7.1987, p. 33.
(2) OJ C 102, 4.4.1996, p. 1.
▼B
regard both to the technology used and the substances to be
analysed or other parameters; whereas this is true in particularof high-density DNA probe devices (known as micro-chips)
used in genetic screening;
(31)Whereas, when a Member State considers that, as regards a
given product or group of products, it is necessary, in order to
protect health and safety and/or ensure compliance with the
imperatives of public health, in accordance with Article 36 ofthe Treaty, to prohibit or restrict their availability or to subjectit to special conditions, it may take any transitional measuresthat are necessary and justified; whereas, in such cases, the
Commission consults the interested parties and the Member
States and, if the national measures are justified, adopts thenecessary Community measures, in accordance withprocedureIII(a) as laid down in Decision 87/373/EEC;
(32)Whereas this Directive covers in vitro diagnostic medical
devices manufactured from tissues, cells or substances of humanorigin; whereas it does not refer to the other medical devicesmanufactured using substances of human origin; whereas, there-fore, work will have to continue in this connection in order to
produce Community legislation as soon as possible;
(33)Whereas, in view of the need to protect the integrity of the
human person during the sampling, collection and use of
substances derived from the human body, it is appropriate to
apply the principles laid down in the Convention of the Councilof Europe for the protection of human rights and dignity of thehuman being with regard to the application of biology and medi-cine; whereas, furthermore, national regulations relating to ethicscontinue to apply;
(34)Whereas, in the interests of overall consistency between direc-tives on medical devices, some of the provisions of thisDirective should be incorporated into Directive 93/42/EEC,
which needs to be amended accordingly;
(35)Whereas it is necessary to draw up as quickly as possible the
legislation which is lacking on medical devices manufactured
using substances of human origin,
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Scope,definitions
1. This Directive shall apply to in vitrodiagnostic medical devices
and their accessories. For the purposes of this Directive, accessoriesshall be treated as in vitrodiagnostic medical devices in their own
right. Both in vitrodiagnostic medical devices and accessories 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, intended
by the manufacturer to be used for human beings for the purpose
of:
— diagnosis, prevention, monitoring, treatment or alleviation of
disease,
— diagnosis, monitoring, treatment, alleviation or compensation
for an injury or handicap,
— investigation, replacement or modification of the anatomy or of
a physiological process,
— control of conception,1998L0079 — EN — 20.11.2003 — 001.001 — 6
▼B
and which does not achieve its principal intended action in or on the
human body by pharmacological, immunological or metabolic means,but which may be assisted in its function by such means;
(b) ‘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 usedalone or in combination, intended by the manufacturer to be usedin vitro for the examination of specimens, including blood and
tissue donations, derived from the human body, solely or princi-
pally 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, whether
vacuum-type or not, specifically intended by their manufacturers
for the primary containment and preservation of specimens derivedfrom 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 for
in vitrodiagnostic examination;
(c) ‘accessory’ means an article which, whilst not being an in vitro
diagnostic medical device, is intended specifically by its manufac-turer to be used together with a device to enable that device to beused in accordance withits intended purpose.
For the purposes of this definition, invasive sampling devices or
those which are directly applied to the human body for the purpose
of obtaining a specimen within the meaning of Directive 93/42/
EEC shall not be considered to be accessories to in vitrodiagnostic
medical devices;
(d) ‘device for self-testing’ means any device intended by the manu-
facturer to be able to be used by lay persons in a homeenvironment;
(e) ‘device for performance evaluation’ means any device intended by
the manufacturer to be subject to one or more performance evalua-
tion studies in laboratories for medical analyses or in otherappropriate environments outside his own premises;
(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, regardless
of 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 devices
with a view to their being placed on the market under his own
name. This subparagraph does not apply to the person who, whilenot a manufacturer within the meaning of the first subparagraph,assembles or adapts devicesalready on the market to their intendedpurpose for an individual patient;
(g) ‘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;
(h) ‘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 for use and/or in promotional materials;1998L0079 — EN — 20.11.2003 — 001.001 — 7
▼B
(i) ‘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 performance evaluation witha view to distribution
and/or use on the Community market, regardless of whether it is
new or fully refurbished;
(j) ‘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.
3. For the purposes of this Directive, calibration and control mate-
rials refer to any substance, material or article intended by theirmanufacturer either to establish measurement relationships or to verifythe performance characteristics of a device in conjunction with theintended use of that device.
4. For the purposes of this Directive, the removal, collection and use
of tissues, cells and substances of human origin shall be governed, inrelation to ethics, by the principles laid down in the Convention of theCouncil of Europe for the protection of human rights and dignity of thehuman being with regard to the application of biology and medicineand by any Member States regulations on this matter.
5. This Directive shall not apply to devices manufactured and used
only within the same health institution and on the premises of theirmanufacture or used on premises in the immediate vicinity withouthaving been transferred to another legal entity. This does not affectthe right of Member State to subject such activities to appropriateprotection requirements.
6. This Directive shall not affect national laws which provide for the
supply of devices by a medical prescription.
7. This Directive is a specific directive within the meaning of
Article 2(2) of Directive 89/336/EEC, which shall cease to apply todevices which have complied with this Directive.
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 comply
with the requirements laid down in this Directive when duly supplied
and properly installed, maintained and used in accordance withth eirintended purpose. This involves the obligation of Member States tomonitor the security and quality of these devices. This Article appliesalso to devices made available for performance evaluation.
Article 3
Essentialrequirements
Devices must meet the essential requirements set out in Annex I which
apply to them, taking account of the intended purpose of the devices
concerned.
Article 4
Free movement
1. Member States shall not create any obstacle to the placing on the
market or the putting into service within their territory of devicesbearing the CE marking provided for in Article 16 if these deviceshave undergone conformity assessment in accordance with Article 9.
2. Member States shall not create any obstacle to devices intended
for performance evaluation being made available for that purpose to
the laboratories or other institutions listed in the statement referred toin Annex VIII if they meet the conditions laid down in Article 9(4)and Annex VIII.
3. At trade fairs, exhibitions, demonstrations, scientific or technical
gatherings, etc. Member States shall not create any obstacle to the1998L0079 — EN — 20.11.2003 — 001.001 — 8
▼B
showing of devices which do not conform to this Directive, provided
that such devices are not used on specimens taken from the participantsand that a visible sign clearly indicates that such devicescannot be
marketed or put into service until they have been made to comply.
4. Member States may require the information to be supplied
pursuant to Annex I, part B, section 8 to be in their official language(s)
when a device reaches the final user.
Provided that safe and correct use of the device is ensured, Member
States may authorise the information referred to in the first subpara-
graphto be in one or more oth er official Community language(s).
In the application of this provision, Member States shall take into
account the principle of proportionality and, in particular:
(a) whether the information can be supplied by harmonised symbols or
recognised codes or other measures;
(b) the type of user anticipated for the device.
5. Where the devices are subject to other directives concerning other
aspects which also provide for the affixing of the CE marking, thelatter shall indicate that the devices also fulfil the provisions of theother 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 andaccompanying suchdevices.
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 transposing theharmonised standards the reference numbers of which have beenpublished in the Official Journal of the European Communities ;
Member States shall publish the reference numbers of such national
standards.
2. If a Member State or the Commission considers that the harmo-
nised standards do not entirely meet the essential requirementsreferred to in Article 3, the measures to be taken by the Member States
with 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).
3. Member States shall presume compliance with the essential
requirements referred to in Article 3 in respect of devices designedand manufactured in conformity withcommon tech nical specificationsdrawn up for the devices in List A of Annex II and, where necessary,the devices in List B of Annex II. These specifications shall establish
appropriate performance evaluation and re-evaluation criteria, batch
release criteria, reference methods and reference materials.
The common technical specifications shall be adopted in accordance
with the procedure mentioned in Article 7(2) and be published in the
Official Journal of the European Communities .
Manufacturers shall as a general rule be required to comply with the
common technical specifications; if for duly justified reasons manufac-
turers do not comply with those specifications they must adopt
solutions of a level at least equivalent thereto.
Where, in this Directive, reference is made to harmonised standards,
this is also meant to refer to the common technical specifications.1998L0079 — EN — 20.11.2003 — 001.001 — 9
▼M1
Article 6
Committee onStandardsandTechnicalRegulations
1. The Commission shall be assisted by the Committee set up by
Article 5 of Directive 98/34/EC (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.
Article 7
1. The Commission shall be assisted by the committee set up by
Article 6(2) of Directive 90/385/EEC.
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 referred to in paragraph 1 may examine any ques-
tion connected with the implementation of this Directive.
Article 8
Safeguardclause
1. Where a Member State ascertains that the devices referred to in
Article 4(1), when correctly installed, maintained and used for theirintended purpose may compromise the health and/or safety of patients,
users or, where applicable, other persons, or the safety of property, it
shall take all appropriate interim measures to withdraw such devicesfrom the market or prohibit or restrict their being placed on the marketor put into service. The Member State shall immediately inform theCommission of any suchmeasures, indicating th e reasons for its deci-sion 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,
insofar 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, the
Commission 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; where themeasure referred to in paragraph1 is attributed to problems relatedto the contents or to the application of the common technical speci-fications, the Commission shall, after consulting the parties1998L0079 — EN — 20.11.2003 — 001.001 — 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
▼B
concerned, bring the matter before the Committee referred to in
Article 7(1) within two months,
— the measures are unjustified, it shall immediately so inform the
Member State which took the initiative and the manufacturer or
his authorised representative.
3. Where a non-complying device bears the CE marking, the compe-
tent Member State shall take appropriate action against whomsoeveraffixed the marking and shall inform the Commission and the other
Member States thereof.
4. The Commission shall ensure that the Member States are kept
informed of the progress and outcome of this procedure.
Article 9
Conformityassessmentprocedures
1. For all devices other than those covered by Annex II and devices
for performance evaluation, the manufacturer shall, in order to affix theCE marking, follow the procedure referred to in Annex III and draw upthe EC declaration of conformity required before placing the devices
on the market.
For all devices for self-testing other than those covered by Annex II
and devices for performance evaluation, the manufacturer shall, priorto the drawing up of the aforementioned declaration of conformity,
fulfil the supplementary requirements set out in Annex III, point 6.
Instead of applying this procedure, the manufacturer may follow theprocedure referred to in paragraphs 2 or 3.
2. For all devices referred to in List A in Annex II other than those
intended for performance evaluation, 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 IV (full quality assurance), or
(b) follow the procedure relating to EC type-examination set out in
Annex V coupled with the procedure relating to the EC declarationof conformity set out in Annex VII (production quality assurance).
3. For all devices referred to in List B in Annex II other than those
intended for performance evaluation, the manufacturer shall for the
purposes of affixing the CE marking, follow either:
(a) the procedure relating to the EC declaration of conformity set out
in Annex IV (full quality assurance) or
(b) the procedure relating to EC type-examination set out in Annex V
couplet with:
(i) the procedure relating to EC verification set out in Annex VI,
or
(ii) the procedure relating to the EC declaration of conformity set
out in Annex VII (production quality assurance).
4. In the case of devices for performance evaluation, the manufac-
turer shall follow the procedure referred to in Annex VIII and drawup the statement set out in that Annex before such devices are madeavailable.
This provision does not affect national regulations relating to the
ethical aspects of carrying out performance evaluation studies usingtissues or substances of human origin.
5. During the conformity assessment procedure for a device, the
manufacturer and, if involved, the notified body shall take account of
the results of any assessment and verification operations which, where
appropriate, have been carried out in accordance with this Directive atan intermediate state of manufacture.
6. The manufacturer may instruct his authorised representative to
initiate the procedures provided for in Annexes III, V, VI and VIII.1998L0079 — EN — 20.11.2003 — 001.001 — 11
▼B
7. The manufacturer must keep the declaration of conformity, the
technical documentation referred to in Annexes III to VIII, as well asthe decisions, reports and certificates, established by notified bodies,
and make it available to the national authorities for inspection purposes
for a period ending five years after the last product has been manufac-tured. Where the manufacturer is not established in the Community, theobligation to make the aforementioned documentation available onrequest applies to his authorised representative.
8. Where the conformity assessment procedure involves intervention
of a notified body, the manufacturer, or authorised representative, may
apply to a body of his choice within the framework of tasks for which
the body has been notified.
9. The notified body may require, where duly justified, any informa-
tion or data, which is necessary for establishing and maintaining the
attestation of conformity in view of the chosen procedure.
10. Decisions taken by the notified bodies in accordance with
Annexes III, IV, and V shall be valid for a maximum of five yearsand may be extended on application, made at a time agreed in thecontract signed by bothparties, for furth er periods of up to five years.
11. The records and correspondence relating to the procedures
referred to in paragraphs 1 to 4 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.
12. By way of derogation from paragraphs 1 to 4, the competent
authorities may authorise, on duly justified request, the placing on the
market and putting into service, within the territory of the Member
State concerned, of individual devices for which the proceduresreferred to in paragraphs 1 to 4 have not been carried out and the useof which is in the interest of protection of health.
13. The provisions of this Article shall apply accordingly to any
natural or legal person who manufacturers devices covered by thisDirective and, without placing them on the market, puts them intoservice and uses them in the context of his professional activity.
Article 10
Registrationofmanufacturersanddevices
1. Any manufacturer who places devices on the market under his
own name shall notify the competent authorities of the Member Statein which he has his registered place of business:
— of the address of the registered place of business,
— of information relating to the reagents, reagent products and calibra-
tion and control materials in terms of common technologicalcharacteristics and/or analytes and of any significant change theretoincluding discontinuation of placing on the market; for otherdevices, the appropriate indications,
— in the case of devices covered by Annex II and of devices for self-
testing, of all data allowing for identification of suchdevices, th eanalytical and, where appropriate, diagnostic parameters as referred
to in Annex I, part A, section 3, the outcome of performance
evaluation pursuant to Annex VIII, certificates and any significantchange thereto, including discontinuation of placing on the market.
2. For devices covered by Annex II and for devices for self-testing,
Member States may request to be informed of the data allowing identi-fication together with the label and the instructions for use when suchdevices are placed on the market and/or put into service within theirterritory.
These measures cannot constitute a precondition for the placing on the
market and/or putting into service of devices which are in conformity
withth is Directive.
3. Where a manufacturer who places devices on the market under
his own name does not have a registered place of business in a1998L0079 — EN — 20.11.2003 — 001.001 — 12
▼B
Member State, he shall designate an authorised representative. The
authorised representative shall notify the competent authorities of theMember State in which he has his registered place of business of all
particulars as referred to in paragraph1.
4. The notification referred to in paragraph 1 shall also include any
new device. In addition, where, in the context of such notification, a
device notified, bearing the CE marking, is a ‘new product’, the manu-facturer shall indicate this fact on his notification.
For the purposes of this Article, a device is ‘new’ if:
(a) there has been no such device continuously available on the
Community market during the previous three years for the relevantanalyte or other parameter;
(b) the procedure involves analytical technology not continuously used
in connection with a given analyte or other parameter on theCommunity market during the previous three years.
5. Member States shall take all necessary measures to ensure that
the notifications referred to in paragraphs 1 and 3 are registered imme-
diately in the databank described in Article 12. The procedures for
implementing this Article and in particular those referring to the notifi-cation and the concept of significant change shall be adopted inaccordance withth e procedure referred to in Article 7.
6. Transitionally, pending the establishment of a European databank
accessible to the competent authorities of the Member States andcontaining the data relating to all devices available on the territory ofthe Community, the manufacturer shall give such notification to the
competent authorities of each Member State concerned by the placing
on the market.
Article 11
Vigilanceprocedure
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 devices bearing the CE marking is recorded and evaluated
centrally:
(a) any malfunction, failure or deterioration in the characteristics and/
or performance of a device, as well as any inadequacy in the label-
ling or the instructions for use which, directly or indirectly, mightlead to or might have led to the death of a patient, or user or ofother persons or to a serious deterioration in their state 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 the
manufacturer.
2. Where a Member State requires medical practitioners, the medical
institutions or the organisers of external quality assessment schemes toinform the competent authorities of any incidents referred to in para-graph 1, it shall take the necessary steps to ensure that themanufacturer of the device concerned, or his authorised representative,is also informed of the incident.
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 of
the incidents referred to in paragraph 1 for which appropriate measures,including possible withdrawal, have been taken or are contemplated.
4. Where, in the context of notification referred to in Article 10, a
device notified, bearing the CE marking, is a ‘new’ product, the manu-facturer shall indicate this fact on his notification. The competentauthority so notified may at any time within the following two yearsand on justified grounds, require the manufacturer to submit a report1998L0079 — EN — 20.11.2003 — 001.001 — 13
▼B
relating to the experience gained with the device subsequent to its
being placed on the market.
5. The Member States shall on request inform the other Member
States of the details referred to in paragraphs 1 to 4. The proceduresimplementing this Article shall be adopted in accordance with theprocedure referred to in Article 7(2).
Article 12
Europeandatabank
1. Regulatory data in accordance with this Directive shall be stored
in a European databank accessible to the competent authorities toenable them to carry out their tasks relating to this Directive on a
well-informed basis.
The databank shall contain the following:
(a) data relating to registration of manufacturers and devices in accor-
dance withArticle 10;
(b) data relating to certificates issued, modified, supplemented,
suspended, withdrawn or refused according to the procedure as
laid down in Annexes III to VII;
(c) data obtained in accordance withth e vigilance procedure as defined
in Article 11.
2. Data shall be forwarded in a standardised format.
3. The procedures implementing this Article shall be adopted in
accordance withth e procedure laid down in Article 7(2).
Article 13
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 and
safety and/or to ensure that public health requirements are observed
pursuant to Article 36 of the Treaty, the availability of such productsshould be prohibited, restricted or made subject to particular require-ments, it may take any necessary and justified transitional measures. Itshall then inform the Commission and all the other Member States,giving the reasons for its decision. The Commission shall consult the
interested parties and the Member States and, where the national
measures are justified, adopt necessary Community measures in accor-dance withth e procedure referred to in Article 7(2).
Article 14
AmendmentstoAnnexII,andderogationclause
1. Where a Member State considers that:
(a) the list of devices in Annex II should be amended or extended, or
(b) the conformity of a device or category of devices should be estab-
lished, by way of derogation from the provisions of Article 9, byapplying one or more given procedures taken from amongst those
referred to in Article 9,
it shall submit a duly substantiated request to the Commission and ask
it to take the necessary measures. The measures shall be adopted inaccordance withth e procedure laid down in Article 7(2).
2. When a measure is to be taken in accordance with paragraph 1,
due consideration shall be given to:
(a) any relevant information available from the vigilance procedures
and from external quality assessment schemes as referred to inArticle 11;1998L0079 — EN — 20.11.2003 — 001.001 — 14
▼B
(b) the following criteria:
(i) whether total reliance has to be placed on the result obtained
with a given device, this result having a direct impact onsubsequent medical action, and
(ii) whether action taken on the basis of an incorrect result
obtained using a given device could prove to be hazardous tothe patient, to a third party or to the public, in particular as a
consequence of false positive or false negative results, and
(iii) whether the involvement of a notified body would be condu-
cive to establishing the conformity of the device.
3. The Commission shall inform the Member States of the measures
taken and, where appropriate, publish these measures in the Official
Journal of the European Communities .
Article 15
Notifiedbodies
1. Member States shall notify the Commission and other Member
States of the bodies which they have designated for carrying out thetasks pertaining to the procedures referred to in Article 9 and thespecific tasks for which the bodies have been designated. The Commis-sion shall assign identification numbers to these bodies, hereinafter
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.
Member States shall not be obliged to designate a notified body.
2. Member States shall apply the criteria set out in Annex IX for the
designation of bodies. Bodies that meet the criteria laid down in thenational standards which transpose the relevant harmonised standardsshall be presumed to meet the relevant criteria.
3. Member States shall apply continual surveillance of notified
bodies to ensure ongoing compliance withth e criteria set out in Annex
IX. A Member State that has notified a body shall withdraw or restrictthat notification if it finds that the body no longer meets the criteriareferred to in Annex IX. It shall immediately inform the other MemberStates and the Commission of any withdrawal of notification or anyrestriction placed on it.
4. The notified body and the manufacturer, or his authorised repre-
sentative established in the Community, shall lay down, by commonaccord, the time limits for completion of the assessment and verifica-tion operations referred to in Annexes III to VII.
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, taking
account of the principle of proportionality, suspend or withdraw the
certificate issued or place any restrictions on it unless compliancewithsuchrequirements is ensured by th e implementation of appropriatecorrective measures by the manufacturer. In the case of suspension orwithdrawal of the certificate or of any restriction placed on it or in
cases where an intervention of the competent authority may become
necessary, the notified body shall inform its competent authoritythereof. The Member State shall inform the other Member States andthe Commission.
7. The notified body shall, on request, supply all relevant informa-
tion and documents, including budgetary documents, required to1998L0079 — EN — 20.11.2003 — 001.001 — 15
▼B
enable the Member State to verify compliance with Annex IX require-
ments.
Article 16
CEmarking
1. Devices, other than devices for performance evaluation, consid-
ered to meet the essential requirements referred to in Article 3 mustbear the CE marking of conformity when they are placed on the
market.
2. The CE marking of conformity, as shown in Annex X, must
appear in a visible, legible and indelible form on the device, wherepracticable and appropriate, and on the instructions for use. The CEmarking of conformity must also appear on the sales packaging. The
CE marking shall be accompanied by the identification number of the
notified body responsible for implementation of the procedures set outin Annexes III, IV, VI and VII.
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 the
CE marking. Any other mark may be affixed to the device, to the
packaging or to the instruction leaflet accompanying the deviceprovided that the visibility and legibility of the CE marking is notthereby reduced.
Article 17
WronglyaffixedCEmarking
1. Without prejudice to Article 8:
(a) where a Member State establishes that the CE marking has been
wrongly affixed, the manufacturer or his authorised representativeshall be obliged to end the infringement under conditions imposed
by the Member State;
(b) where non-compliance continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on the
market of the product in question or to ensure that it is withdrawn
from the market, in accordance with the procedure in Article 8.
2. The provisions stated in paragraph 1 shall also apply where the
CE marking has been affixed in accordance with the procedures inthis Directive, but inappropriately, on products that are not covered by
this Directive.
Article 18
Decisionsinrespectofrefusalorrestriction
1. Any decision taken pursuant to this Directive:
(a) to refuse or restrict the placing on the market or any making avail-
able or putting into service of a device, 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 partyconcerned, 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 authorised representative shall have an opportunity toput forward his point of view in advance, unless such consultation isnot possible because of the urgency of the measure to be taken as justi-fied in particular by public health requirements.1998L0079 — EN — 20.11.2003 — 001.001 — 16
▼B
Article 19
Confidentiality
Without prejudice to national law and practice on medical secrecy,
Member States shall ensure that all the parties involved in the applica-tion of this Directive are bound to observe confidentiality with regardto information obtained in carrying out their tasks. This does not affectthe obligations of Member States and notified bodies with regard to
mutual information and the dissemination of warnings, nor the obliga-
tions of the persons concerned to provide information under criminallaw.
Article 20
CooperationbetweenMemberStates
Member States shall take appropriate measures to ensure that compe-
tent authorities charged with the implementation of this Directivecooperate with each other and convey to each other the informationnecessary to ensure application in compliance withth is Directive.
Article 21
Amendmentofdirectives
►
C21. In Directive 98/37/EC, ◄the second indent of Article
1(3), ‘machinery for medical use, used in direct contact with patients’shall be replaced by the following:
‘— medical devices,’.
2. Directive 93/42/EEC is hereby amended as follows:
(a) in Article 1(2):
— point (c) shall be replaced by the following:
‘(c) “in vitrodiagnostic medical device” means any medical
device which is a reagent, reagent product, calibrator,control material, kit, instrument, apparatus, equipment orsystem, whether used alone or in combination, intended
by the manufacturer to be used in vitrofor the examination
of specimens, including blood and tissue donations,
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
recipients, or
— to monitor therapeutic measures.
Specimen receptacles are considered to be in vitrodiag-
nostic medical devices. “Specimen receptacles” are thosedevices, whether vacuum-type or not, specifically intendedby their manufacturers for the primary containment andpreservation of specimens derived from the human body
for the purpose of in vitrodiagnostic examination.
Products for general laboratory use are not in vitrodiag-
nostic medical devices unless suchproducts, in view oftheir characteristics, are specifically intended by theirmanufacturer to be used for in vitrodiagnostic examina-
tion;’
— point (i) shall be replaced by the following:
‘(i) “putting into service” means the stage at which a device
has been made available to the final user as being readyfor use on the Community market for the first time for its
intended purpose;’
— the following point shall be added:
‘(j) “authorised representative” means any natural or legal
person established in the Community who, explicitly desig-1998L0079 — EN — 20.11.2003 — 001.001 — 17
▼B
nated by the manufacturer, acts and may be addressed by
authorities and bodies in the Community instead of themanufacturer withregard to th e latter's obligations under
this Directive;’
(b) Article 2 shall be replaced by the following:
‘Article 2
PlacingonthemarketandputtingintoserviceMember States shall take all necessary steps to ensure that devices
may be placed on the market and/or put into service only if they
comply with the requirements laid down in this Directive whenduly supplied andproperly installed, maintained and used in accor-dance withth eir intended purpose.’
(c) the following paragraph shall be added to Article 14(1):
‘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.’
(d) the following Articles shall be inserted:
‘Article 14a
Europeandatabank1. Regulatory data in accordance with this Directive shall be
stored in a European database accessible to the competent authori-
ties to enable them to carry out their tasks relating to this Directiveon a well-informed basis.
The databank shall contain the following:
(a) data relating to registration of manufacturers and devices in
accordance withArticle 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 withth e 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 withth e procedure laid down in Article 7(2).’
Article 14bParticular 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 observedpursuant to Article 36 of the Treaty, the availability of suchproducts should be prohibited, restricted or subjected to particular
requirements, it may take any necessary and justified transitional
measures. It shall then inform the Commission and all the otherMember States giving the reasons for its decision. The Commissionshall, whenever possible, consult the interested parties and theMember States and, where the national measures are justified,
adopt necessary Community measures in accordance withth e
procedure referred to in Article 7(2).’
(e) the following paragraphs shall be added to Article 16:
‘5. The notified body shall inform the other notified bodies and
the competent authority about all certificates suspended or with-drawn and, on request, about certificates issued or refused. It shallalso make available, 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 manu-facturer or where a certificate should not have been issued, it shall,taking account of the principle of proportionality, suspend or with-draw the certificate issued or place any restrictions on it unless1998L0079 — EN — 20.11.2003 — 001.001 — 18
▼B
compliance withsuchrequirements is ensured by th e implementa-
tion of appropriate corrective measures by the manufacturer. In thecase of suspension or withdrawal of the certificate or of any restric-
tion placed on it or in cases where an intervention of the competent
authority may become necessary, the notified body shall inform itscompetent authority thereof. The Member State shall inform theother Member States and the Commission.
7. The notified body shall, on request, supply all relevant infor-
mation and documents including budgetary documents, required to
enable the Member State to verify compliance with Annex XIrequirements.’
(f) the following paragraph shall be added to Article 18:
‘Those provisions shall also apply where the CE marking has been
affixed in accordance with the procedures in this Directive, but
inappropriately, on products that are not covered by this Directive.’
(g) in Article 22(4), the first subparagraph shall be replaced by the
following:
‘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 five years following the adoption of this Directive, and
— the aforementioned devices being put into service until 30 June
2001 at the latest.’
(h) Annex II, section 6.2, Annex III, section 7.1, Annex V, section 5.2
and Annex VI, section 5.2 shall be deleted;
(i) in Annex XI, section 3 the following sentence shall be inserted
after the second sentence: ‘This presupposes the availability of
sufficient scientific staff within the organisation who possess
experience and knowledge sufficient to assess the medical function-ality and performance of devices for which it has been notified,having regard to the requirements of this Directive and, in parti-cular, those set out in Annex I.’
Article 22
Implementation,transitionalprovisions
1. Member States shall adopt and publish the laws, regulations and
administrative provisions necessary to comply withth is Directive notlater than 7 December 1999. They shall immediately inform theCommission thereof.
Member States shall apply these provisions with effect from 7 June
2000.
When Member States adopt these provisions, they shall contain a refer-
ence to this Directive or shall be accompanied by such a reference on
the occasion of their official publication. The methods of making such
a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the texts of
the main provisions of domestic law which they adopt in the fieldgoverned by this Directive.
3. The Committee referred to in Article 7 may undertake its tasks
from the date of entry into force of this Directive. The Member Statesmay take the measures referred to in Article 15 ►
C1as from the entry
into force of this Directive. ◄
4. Member States shall take the necessary action to ensure that the
notified bodies which are responsible pursuant to Article 9 for confor-
mity assessment take account of any relevant information regarding thecharacteristics and performance of such devices, including in particularthe results of any relevant test and verification already carried outunder pre-existing national law, regulations or administrative provisionsin respect of suchdevices.1998L0079 — EN — 20.11.2003 — 001.001 — 19
▼B
5. During a period of five years following the entry into force of this
Directive, Member States shall accept the placing on the market ofdevices which conform to the rules in force in their territory on the
date on which this Directive enters into force. For an additional period
of two years, the said devices may be put into service.
Article 23
This Directive shall enter into force on the day of its publication in the
Official Journal of the European Communities .
Article 24
This Directive is addressed to the Member States.1998L0079 — EN — 20.11.2003 — 001.001 — 20
▼B
ANNEX I
ESSENTIALREQUIREMENTS
A. 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, directly or indirectly, the clinical condition or
the safety of the patients, the safety or health of users or, where
applicable, other persons, or the safety of property. Any risks which
may be associated with their use must be acceptable when weighed
against the benefits to the patient and be compatible with a high level
of protection of health and safety.
2. The solutions adopted by the manufacturer for the design and
construction 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 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 be designed and manufactured in such a way that
they are suitable for the purposes referred to in Article 1(2)(b), as
specified by the manufacturer, taking account of the generally
acknowledged state of the art. They must achieve the performances,
in particular, where appropriate, in terms of analytical sensitivity,
diagnostic sensitivity, analytical specificity, diagnostic specificity,
accuracy, repeatability, reproducibility, including control of known
relevant interference, and limits of detection, stated by the manufac-
turer.
The traceability of values assigned to calibrators and/or control mate-
rials must be assured through available reference measurement
procedures and/or available reference materials of a higher order.
4. The characteristics and performances referred to in sections 1 and 3
must not be adversely affected to such a degree that the health or the
safety of the patient or the user and, where applicable, of other
persons, are compromised during the lifetime of the device as indi-
cated by the manufacturer, when the device is subjected to the
stresses which can occur during normal conditions of use. When no
lifetime is stated, the same applies for the lifetime reasonably to be
expected of a device of that kind, having regard to the intended
purpose and the anticipated use of the device.
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 under storage and transport condi-
tions (temperature, humidity, etc.) taking account of the instructions
and information provided by the manufacturer.
B. DESIGN AND MANUFACTURING REQUIREMENTS
1.Chemicalandphysicalproperties
1.1. The devices must be designed and manufactured in such a way as to
achieve the characteristics and performances referred to in section A
on the ‘General requirements’. Particular attention must be paid to
the possibility of impairment of analytical performance due to incom-
patibilitybetween the materials used and the specimens (such as
biological tissues, cells, body fluids and micro-organisms) intended
to be used withth e device, taking account of its intended purpose.
1.2. The devices must be designed, manufactured and packed in such a
way as to reduce as far as possible the risk posed by product leakage,
contaminants and residues to the persons involved in the transport,
storage and use of the devices, taking account of the intended
purpose of the products.1998L0079 — EN — 20.11.2003 — 001.001 — 21
▼B
2.Infectionandmicrobial contamination
2.1. The devices and their manufacturing processes must be designed in
sucha way as to eliminate or reduce as far as possible th e risk of
infection to the user or other persons. The design must allow easy
handling and, where necessary, reduce as far as possible contamina-
tion of, and leakage from, the device during use and, in the case of
specimen receptacles, the risk of contamination of the specimen. The
manufacturing processes must be appropriate for these purposes.
2.2 Where a device incorporates biological substances, the risks of infec-
tion must be reduced as far as possible by selecting appropriate
donors and appropriate substances and by using appropriate, vali-
dated inactivation, conservation, test and control procedures.
2.3. Devices labelled either as ‘STERILE’ or as having a special micro-
biological state must be designed, manufactured and packed in an
appropriate pack, according to procedures suitable for ensuring that
they remain in the appropriate microbiological state indicated on the
label when placed on the market, under the storage and transport
conditions specified by the manufacturer, until the protective packa-
ging is damaged or opened.
2.4. Devices labelled either as ‘STERILE’ or as having a special micro-
biological state must have been processed by an appropriate,
validated method.
2.5. Packaging systems for devices other than those referred to in section
2.3 must keep the product without deterioration at the level of clean-
liness indicated by the manufacturer and, if the devices are to be
sterilised prior to use, reduce as far as possible the risk of microbial
contamination.
Steps must be taken to reduce as far as possible microbial contamina-
tion during selection and handling of raw materials, manufacture,
storage and distribution where the performance of the device can be
adversely affected by suchcontamination.
2.6. Devices intended to be sterilised must be manufactured in appropri-
ately controlled (e.g. environmental) conditions.
2.7. Packaging systems for non-sterile devices must keep the product
without deterioration at the level of cleanliness stipulated and, if the
devices are to be sterilised prior to use, minimise the risk of micro-
bial contamination; the packaging system must be suitable taking
account of the method of sterilisation indicated by the manufacturer.
3.Manufacturingandenvironmentalproperties
3.1. 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 the
devices. Any restrictions on use must be indicated on the label and/or
in the instructions for use.
3.2. Devices must be designed and manufactured in sucha way as to
reduce as far as possible the risks linked to their use in conjunction
withmaterials, substances and gases withwh ichth ey may come into
contact during normal conditions of use.
3.3. Devices must be designed and manufactured in sucha way as to
remove or reduce as far as possible:
— the risk of injury linked to their physical features (in particular
aspects of volume × pressure, dimension and, where appropriate,
ergonomic features),
— risks linked to reasonably foreseeable external influences, suchas
magnetic fields, external electrical effects, electrostatic discharge,
pressure, humidity, temperature or variations in pressure or accel-
eration or accidental penetration of substances into the device.
Devices must be designed and manufactured in sucha way as to
provide an adequate level of intrinsic immunity of electromagnetic
disturbance to enable them to operate as intended.
3.4. Devices must be designed and manufactured in sucha way as to
reduce as far as possible 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 or use in association
withflammable substances or substances wh ichcould cause combus-
tion.1998L0079 — EN — 20.11.2003 — 001.001 — 22
▼B
3.5. Devices must be designed and manufactured in sucha way as to
facilitate the management of safe waste disposal.
3.6. The measuring, monitoring or display scale (including colour change
and other visual indicators) must be designed and manufactured in
line withergonomic principles, taking account of th e intended
purpose of the device.
4.Devices which are instruments or apparatus with a measuring
function
4.1. Devices which are instruments or apparatus having a primary analy-
tical measuring function must be designed and manufactured in such
a way as to provide adequate stability and accuracy of measurement
within appropriate accuracy limits, taking into account the intended
purpose of the device and of available and appropriate reference
measurement procedures and materials. The accuracy limits have to
be specified by the manufacturer.
4.2. When values are expressed numerically, they must be given in legal
units conforming to the provisions of Council Directive 80/181/EEC
of 20 December 1979 on the approximation of the laws of the
Member States relating to units of measurement (1).
5.Protection againstradiation
5.1. Devices shall be designed, manufactured and packaged in such a way
that exposure of users and other persons to the emitted radiation is
minimised.
5.2. When devices are intended to emit potentially hazardous, visible and/
or invisible radiation, they must as far as possible be:
— designed and manufactured in such a way as to ensure that the
characteristics and the quantity of radiation emitted can be
controlled and/or adjusted,
— fitted withvisual displays and/or audible warnings of suchemis-
sions.
5.3. The operating instructions for devices emitting radiation must give
detailed information as to the nature of the emitted radiation, means
of protecting the user, and on ways of avoiding misuse and of elim-
inating the risks inherent in installation.
6.Requirements for medical devices connected to or equipped with
anenergysource
6.1. Devices incorporating electronic programmable systems, including
software, must be designed to ensure the repeatability, reliability
and performance of these systems according to the intended use.
6.2. Devices must be designed and manufactured in sucha way as to
minimise the risks of creating electromagnetic perturbation which
could impair the operation of other devices or equipment in the usual
environment.
6.3. Devices must be designed and manufactured in sucha 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 and maintained correctly.
6.4.Protection against mechanical and thermal risks
6.4.1. Devices must be designed and manufactured in sucha way as to
protect the user against mechanical risks. Devices must be suffi-
ciently stable under the foreseen operating conditions. They must be
suitable to withstand stresses inherent in the foreseen working envir-
onment, and to retain this resistance during the expected life of the
devices, subject to any inspection and maintenance requirements as
indicated by the manufacturer.
Where there are risks due to the presence of moving parts, risks due
to break-up or detachment, or leakage of substances, then appropriate
protection means must be incorporated.1998L0079 — EN — 20.11.2003 — 001.001 — 23
(1) OJ L 39, 15.2.1980, p. 40. Directive as last amended by Directive 89/617/EEC (OJ L
357, 7.12.1989, p. 28).
▼B
Any guards or other means included with the device to provide
protection, in particular against moving parts, must be secure and
must not interfere with access for the normal operation of the device,
or restrict routine maintenance of the device as intended by the
manufacturer.
6.4.2. Devices must be designed and manufactured in sucha 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 available for limiting vibrations, particularly at source,
unless the vibrations are part of the specified performance.
6.4.3. Devices must be designed and manufactured in sucha way as to
reduce as far as possible 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.
6.4.4. Terminals and connectors to electricity, gas or hydraulic and pneu-
matic energy supplies which the user has to handle must bedesigned and manufactured in sucha way as to minimise all possible
risks.
6.4.5. Accessible parts of the devices (excluding the parts of areas intended
to supply heat or reach given temperatures) and their surroundings
must not attain potentially dangerous temperatures under normal use.
7.Requirementsfordevicesforself-testing
Devices for self-testing must be designed and manufactured in sucha
way that they perform appropriately for their intended purpose taking
into account the skills and the means available to users and the influ-
ence resulting from variation that can reasonably be anticipated in
users' technique and environment. The information and instructions
provided by the manufacturer should be easily understood and
applied by the user.
7.1. Devices for self-testing must be designed and manufactured in sucha
way as to:
— ensure that the device is easy to use by the intended lay user at
all stages of the procedure, and
— reduce as far as practicable the risk of user error in the handling
of the device and in the interpretation of the results.
7.2. Devices for self-testing must, where reasonably possible, include user
control, i.e. a procedure by which the user can verify that, at the time
of use, the product will perform as intended.
8.Informationsuppliedbythemanufacturer
8.1. Eachdevice must be accompanied by th e information needed to use
it safely and properly, taking account of the training and knowledge
of the potential users, and to identify the manufacturer.
This information comprises the data on the label and in the instruc-
tions for use.
As far as practicable and appropriate, the information needed to use
the device safely and properly must be set out on the device itself
and/or, where appropriate, on the sales packaging. If individual full
labelling of eachunit is not practicable, th e information must be set
out on the packaging and/or in the instructions for use supplied with
one or more devices.
Instructions for use must accompany or be included in the packaging
of one or more devices.
In duly justified and exceptional cases no suchinstructions for use
are needed for a device if it can be used properly and safely without
them.
The decision whether to translate the instructions for use and the
label into one or more languages of the European Union shall be
left to the Member States, except that, for devices for self-testing,
the instructions for use and the label must include a translation into
the official language(s) of the Member State in which the device for
self-testing reaches its final user.1998L0079 — EN — 20.11.2003 — 001.001 — 24
▼C1
▼B
8.2. Where appropriate, the information to be supplied should take the
form of symbols. Any symbol and identification colour used must
conform to the harmonised standards. In areas for which no standards
exist, the symbols and colour used must be described in the docu-
mentation supplied withth e device.
8.3. In the case of devices containing or a preparation which may be
considered as being dangerous, taking account of the nature and
quantity of its constituents and the form under which they are
present, relevant danger symbols and labelling requirements of Direc-
tive 67/548/EEC (1) and Directive 88/379/EEC (2) shall apply. Where
there is insufficient space to put all the information on the device
itself or on its label, the relevant danger symbols shall be put on the
label and the other information required by those Directives shall be
given in the instructions for use.
The provisions of the aforementioned Directives on the safety data
sheet shall apply, unless all relevant information as appropriate is
already made available by the instructions for use.
8.4. The label must bear the following particulars which may take the
form of symbols as appropriate:
(a) the name or trade name and address of the manufacturer. For
devices imported into the Community with a view to their distri-
bution in the Community, the label, the outer packaging, or the
instructions for use shall contain in addition the name and
address of the authorised representative of the manufacturer;
(b) the details strictly necessary for the user to uniquely identify the
device and the contents of the packaging;
(c) where appropriate, the word ‘STERILE’ or a statement indicating
any special microbiological state or state of cleanliness;
(d) the batch code, preceded by the word ‘LOT’, or the serial
number;
(e) if necessary, an indication of the date by which the device or part
of it should be used, in safety, without degradation of perfor-
mance, expressed as the year, the month and, where relevant,
the day, in that order;
(f) in case of devices for performance evaluation, the words ‘for
performance evaluation only’;
(g) where appropriate, a statement indicating the in vitrouse of the
device;
(h) any particular storage and/or handling conditions;
(i) where applicable, any particular operating instructions;
(j) appropriate warnings and/or precautions to take;
(k) if the device is intended for self-testing, that fact must be clearly
stated.
8.5. If the intended purpose of the device is not obvious to the user, the
manufacturer must clearly state the intended purpose in the instruc-
tions for use and, if appropriate, on the label.
8.6. Wherever reasonable and practicable, the devices and separate
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.
8.7. Where appropriate, the instructions for use must contain the
following particulars:
(a) the details referred to in section 8.4 with the exception of points
(d) and (e);
(b) composition of the reagent product by nature and amount or
concentration of the active ingredient(s) of the reagent(s) or kit
as well as a statement, where appropriate, that the device1998L0079 — EN — 20.11.2003 — 001.001 — 25
(1) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regula-
tions and administrative provisions relating to the classification, packaging and
labelling of dangerous substances (OJ L 196, 16.8.1967, p. 1). Directive as last
amended by Commission Directive 97/69/EC (OJ L 343, 13.12.1997, p. 19).
(2) Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regu-
lations and administrative provisions of the Member States relating to the classification,packaging and labelling of dangerous preparations (OJ L 187, 16.7.1988, p. 14). Direc-
tive as last amended by Commission Directive 96/65/EC (OJ L 265, 18.10.1996, p. 15).
▼B
contains other ingredients which might influence the measure-
ment;
(c) the storage conditions and shelf life following the first opening
of the primary container, together with the storage conditions
and stability of working reagents;
(d) the performances referred to in section 3 of part A;
(e) an indication of any special equipment required including infor-
mation necessary for the identification of that special equipment
for proper use;
(f) the type of specimen to be used, any special conditions of
collection, pre-treatment and, if necessary, storage conditions
and instructions for the preparation of the patient;
(g) a detailed description of the procedure to be followed in using
the device;
(h) the measurement procedure to be followed with the device
including as appropriate:
— the principle of the method,
— the specific analytical performance characteristics (e.g. sensi-
tivity, specificity, accuracy, repeatability, reproducibility,
limits of detection and measurement range, including infor-
mation needed for the control of known relevant
interferences), limitations of the method and information
about the use of available reference measurement procedures
and materials by the user,
— the details of any further procedure or handling needed
before the device can be used (for example, reconstitution,
incubation, dilution, instrument checks, etc.),
— the indication whether any particular training is required;
(i) the mathematical approach upon which the calculation of the
analytical result is made;
(j) measures to be taken in the event of changes in the analytical
performance of the device;
(k) information appropriate to users on:
— internal quality control including specific validation proce-
dures,
— the traceability of the calibration of the device;
(l) the reference intervals for the quantities being determined,
including a description of the appropriate reference population;
(m) if the device must be used in combination with or 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 and proper combination;
(n) all the information needed to verify whether the device is prop-
erly installed and can operate correctly and safely, plus details of
the nature and frequency of the maintenance and calibration
needed to ensure that the device operates properly and safely;
information about safe waste disposal;
(o) details of any further treatment or handling needed before the
device can be used (for example, sterilisation, final assembly,
etc.);
(p) the necessary instructions in the event of damage to the protec-
tive packaging and details of appropriate methods of
resterilisation or decontamination;
(q) if the device is reusable, information on the appropriate
processes to allow reuse, including cleaning, disinfection, packa-
ging and resterilisation or decontamination, and any restriction
on the number of reuses;
(r) precautions to be taken as regards exposure, in reasonably fore-
seeable environmental conditions, to magnetic fields, external
electrical influences, electrostatic discharge, pressure or varia-
tions in pressure, acceleration, thermal ignition sources, etc.;
(s) precautions to be taken against any special, unusual risks related
to the use or disposal of the device including special protective
measures; where the device includes substances of human or
animal origin, attention must be drawn to their potential infec-
tious nature;1998L0079 — EN — 20.11.2003 — 001.001 — 26
▼B
(t) specifications for devices for self-testing:
— the results need to be expressed and presented in a way that
is readily understood by a lay person; information needs to
be provided withadvice to th e user on action to be taken
(in case of positive, negative or indeterminate result) and on
the possibility of false positive or false negative result,
— specific particulars may be omitted provided that the other
information supplied by the manufacturer is sufficient to
enable the user to use the device and to understand the
result(s) produced by the device,
— the information provided must include a statement clearly
directing that the user should not take any decision of
medical relevance without first consulting his or her medical
practitioner,
— the information must also specify that when the device for
self-testing is used for the monitoring of an existing disease,
the patient should only adapt the treatment if he has received
the appropriate training to do so;
(u) date of issue or latest revision of the instructions for use.1998L0079 — EN — 20.11.2003 — 001.001 — 27
▼B
ANNEX II
LISTOFDEVICESREFERREDTOINARTICLE9(2)AND(3)
ListA
— Reagents and reagent products, including related calibrators and control
materials, for determining the following blood groups: ABO system, rhesus
(C, c, D, E, e) anti-Kell,
— reagents and reagent products, including related calibrators and control mate-
rials, for the detection, confirmation and quantification in human specimens
of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B,
C and D.
ListB
— Reagents and reagent products, including related calibrators and control
materials, for determining the following blood groups: anti-Duffy and anti-
Kidd,
— reagents and reagent products, including related calibrators and control mate-
rials, for determining irregular anti-erythrocytic antibodies,
— reagents and reagent products, including related calibrators and control mate-
rials, for the detection and quantification in human samples of the following
congenital infections: rubella, toxoplasmosis,
— reagents and reagent products, including related calibrators and control mate-
rials, for diagnosing the following hereditary disease: phenylketonuria,
— reagents and reagent products, including related calibrators and control mate-
rials, for determining the following human infections: cytomegalovirus,
chlamydia,
— reagents and reagent products, including related calibrators and control mate-
rials, for determining the following HLA tissue groups: DR, A, B,
— reagents and reagent products, including related calibrators and control mate-
rials, for determining the following tumoral marker: PSA,
— reagents and reagent products, including related calibrators, control materials
and software, designed specifically for evaluating the risk of trisomy 21,
— the following device for self-diagnosis, including its related calibrators and
control materials: device for the measurement of blood sugar.1998L0079 — EN — 20.11.2003 — 001.001 — 28
▼B
ANNEX III
ECDECLARATIONOFCONFORMITY
1. The EC declaration of conformity is the procedure whereby the manufac-
turer or his authorised representative who fulfils the obligations imposed
by section 2 to 5 and additionally, in the case of devices for self-testing,
the obligations imposed by section 6, 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 withArticle 16.
2. The manufacturer must prepare the technical documentation described in
section 3 and ensure that the manufacturing process follows the princi-
ples of quality assurance as set out in section 4.
3. The technical documentation must allow assessment of the conformity of
the product with the requirements of the Directive. It must include in
particular:
— a general description of the product, including any variants planned,
— the documentation of the quality system,— design information, including the determination of the characteristics
of the basic materials, characteristics and limitation of the perfor-
mance of the devices, methods of manufacture and, in the case of
instruments, design drawings, diagrams of components, sub-assem-
blies, circuits, etc.,
— in the case of devices containing tissues of human origin or
substances derived from suchtissue, information on th e origin of
such material and on the conditions in which it was collected,
— the descriptions and explanations necessary to understand the above-
mentioned characteristics, drawings and diagrams and the operation
of the product,
— the results of the risk analysis and, where appropriate, 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 of the Directive if the standards referred to in Article 5 have
not been applied in full,
— in the case of sterile products or products with a special microbiolo-
gical state or state of cleanliness, a description of the procedures
used,
— the results of the design calculations and of the inspections carried
out, etc.,
— if the device is to be combined with other device(s) in order to
operate as intended, proof must be provided that it conforms to the
essential requirements when combined with any such device(s)
having the characteristics specified by the manufacturer,
— the test reports,
— adequate performance evaluation data showing the performances
claimed by the manufacturer and supported by a reference measure-
ment system (when available), with information on the reference
methods, the reference materials, the known reference values, the
accuracy and measurement units used; suchdata sh ould originate
from studies in a clinical or other appropriate environment or result
from relevant biographical references,
— the labels and instructions for use,— the results of stability studies.
4. The manufacturer shall take necessary measures to ensure that the manu-
facturing process follows the principles of quality assurance as
appropriate for the products manufactured.
The system shall address:
— the organisational structure and responsibilities,
— the manufacturing processes and systematic quality control of
production,
— the means to monitor the performance of the quality system.
5. The manufacturer shall institute and keep up to date a systematic proce-
dure 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 to1998L0079 — EN — 20.11.2003 — 001.001 — 29
▼B
the product. He shall notify the competent authorities of the following
incidents immediately on learning of them:
(i) any malfunction, failure 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, directly or indirectly, might lead
to, or might have led to, the death of a patient or user or other
persons or to a serious deterioration in his or their 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 subpara-
graph(i) leading to systematic recall of devices of th e same type
by the manufacturer.
6. For devices for self-testing the manufacturer shall lodge an application
for examination of the design with a notified body.
6.1. The application shall enable the design of the device to be understood
and shall enable conformity with the design-related requirements of the
directive to be assessed.
It shall include:
— test reports including, where appropriate, results of studies carried out
withlay persons,
— data showing the handling suitability of the device in view of its
intended purpose for self-testing,
— the information to be provided with the device on its label and its
instructions for use.
6.2. The notified body shall examine the application and, if the design
conforms to the relevant provisions of this Directive shall issue the appli-
cant withan EC design-examination certificate. Th e notified body may
require the application to be completed by further tests or proof to allow
assessment of conformity with the design-related requirements of the
Directive. The certificate shall contain the conclusions of the examina-
tion, the conditions of validity, the data needed for identification of the
approved design and, where appropriate, a description of the intended
purpose of the product.
6.3. The applicant shall inform the notified body which issued the EC design-
examination certificate of any significant change made to the approved
design. Changes to the approved design must receive further approval
from the notified body which issued the EC design-examination certifi-
cate wherever the changes could affect conformity with the essential
requirements of the Directive or with the conditions prescribed for use
of the product. This additional approval shall take the form of a supple-
ment to the EC design-examination certificate.1998L0079 — EN — 20.11.2003 — 001.001 — 30
▼B
ANNEX IV
ECDECLARATIONOFCONFORMITY
(FULL QUALITY ASSURANCE SYSTEM)
1. The manufacturer must ensure application of the quality system approved
for the design, manufacture and final inspection of the devices
concerned, as specified in section 3, and is subject to audit as laid
down in section 3.3 and to the surveillance as specified in section 5. In
addition, the manufacturer must follow, for devices covered by Annex II,
List A, the procedures laid down in sections 4 and 6.
2. The declaration of conformity is the procedure whereby the manufacturer
who fulfils the obligations imposed by section 1 ensures and declares
that the devices concerned meet the provisions of this Directive which
apply to them.
The manufacturer shall affix the CE marking in accordance with Article
16 and shall draw up a declaration of conformity covering the devices
concerned.
3.Qualitysystem
3.1. The manufacturer must lodge an application for assessment of his quality
system witha notified body.
The application must include:
— the name and address of the manufacturer and any additional manu-
facturing site covered by the quality system,
— adequate information on the device or device category covered by the
procedure,
— a written declaration that no such application has been lodged with
any other notified body for the same device-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 keep up to 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 and notification as referred to in
Annex III, section 5.
3.2. Application of the quality system must ensure that the devices 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, suchas quality programmes, quality plans,
quality manuals and quality records.
It shall include in particular an adequate description of:
(a) the manufacturer's quality objectives;
(b) the organisation of the business and in particular:
— the organisational structures, the responsibilities of the manage-
rial staff and their organisational authority where quality of
design and manufacture of the devices 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 devices which fail
to conform;
(c) the procedures for monitoring and verifying the design of the devices
and in particular:
— a general description of the device, including any variants
planned,
— all documentation referred to in Annex III, section 3, indents 3 to
13,
— in the case of devices for self-testing, the information referred to
in Annex III, section 6.1,1998L0079 — EN — 20.11.2003 — 001.001 — 31
▼B
— the techniques used to control and verify the design and the
processes and systematic measures which will be used when the
devices are being designed;
(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 sterilisation,
— the procedures in relation to purchasing,
— 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 calibration.
The manufacturer shall carry out the required controls and tests
according to the latest state of the art. The controls and tests shall cover
the manufacturing process including the characterisation of the raw
material and the individual devices or each batch of devices manufac-
tured.
In testing the devices covered by Annex II, List A, the manufacturer
shall take into account the most recent available information, in parti-
cular as regards the biological complexity and variability of the
specimens to be tested withth e in vitrodevice concerned.
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 harmonised standards
conform to the requirements.
The assessment team must have experience of assessments of the tech-
nology 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 shall 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
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 manufacturer of its decision.
This decision must contain the conclusions of the inspection and a
reasoned assessment.
4.Examinationofthedesignoftheproduct
4.1. For devices covered by Annex II, List A, 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
device 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 device in question. It must include the documents needed to assess
whether the device conforms to the requirements of this Directive, asreferred to in section 3.2(c).
4.3. The notified body must examine the application and, if the device
conforms to the relevant provisions of the Directive, issue the application
withan EC design-examination certificate. Th e notified body may
require the application to be completed by further tests or proof to allow
assessment of conformity with the requirements of the Directive. The
certificate must contain the conclusions of the examination, the condi-
tions of validity, the data needed for the identification of the approved
design and, where appropriate, a description of the intended purpose of
the device.
4.4. Changes to the approved design must receive further approval from the
notified body which issued the EC design-examination certificate wher-
ever the changes could affect conformity with the essential requirements
of the Directive or with the conditions prescribed for use of the device.
The applicant shall inform the notified body which issued the EC design-1998L0079 — EN — 20.11.2003 — 001.001 — 32
▼B
examination certificate of any such changes made to the approved
design. The additional approval must take the form of a supplement to
the EC design-examination certificate.
4.5. The manufacturer shall inform the notified body without delay if it has
obtained information about changes to the pathogen and markers of
infections to be tested, in particular as a consequence of biological
complexity and variability. In this connection, the manufacturer shall
inform the notified body whether any such change is likely to affect the
performance of the in vitrodiagnostic medical device concerned.
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 authorise the notified body to carry out all the
necessary inspections and supply it withall relevant information, in
particular:
— the documentation on the quality system,
— the data stipulated in the part of the quality system relating to design,
suchas th e results of analyses, calculation, tests, etc.,
— the data stipulated in the part of the quality system relating to manu-
facture, suchas 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 manu-
facturer. 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.Verificationofmanufacturedproductscovered byAnnexII,ListA
6.1. In the case of devices covered by Annex II, List A, the manufacturer
shall forward to the notified body without delay after the conclusion of
the controls and tests the relevant reports on the tests carried out on the
manufactured devices or each batch of devices. Furthermore, the manu-
facturer shall make the samples of manufactured devices or batches of
devices available to the notified body in accordance with pre-agreed
conditions and modalities.
6.2. The manufacturer may place the devices on the market, unless the noti-
fied body communicates to the manufacturer within the agreed time-
frame, but not later than 30 days after reception of the samples, any
other decision, including in particular any condition of validity of deliv-
ered certificates.1998L0079 — EN — 20.11.2003 — 001.001 — 33
▼B
ANNEX V
ECTYPE-EXAMINATION
1. EC type-examination is the part of the procedure whereby a notified
body ascertains and certifies that a representative sample of the produc-
tion envisaged fulfils the relevant provisions of this Directive.
2. The application for EC type-examination shall be lodged by the manu-
facturer or by his authorised representative with a notified body.
The application shall include:
— the name and the address of the manufacturer and the name and
address of the authorised representative if the application is lodged
by the representative,
— 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
Directive. The applicant shall 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
manufacture and the performances of the device. The documentation
shall contain the following items in particular:
— a general description of the type, including any variants planned,
— all documentation referred to in Annex III, section 3, indents 3 to 13,
— in the case of devices for self testing, the information referred to in
Annex III, section 6.1.
4. The notified body shall:
4.1. examine and assess the documentation and verify that the type has been
manufactured in conformity with that documentation; it shall also record
the items designed in conformity with the applicable provisions of the
standards 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. perform or have performed appropriate examinations and the tests neces-
sary to verify whether the solutions adopted by the manufacturer meet
the essential requirements of this Directive if the standards referred to
in Article 5 have not been applied; if the device is to be combined with
other device(s) in order to operate as intended, proof must be provided
that it conforms to the essential requirements when combined with any
such device(s) having the characteristics specified by the manufacturer;
4.3. carry out or ask for the appropriate examinations and the tests necessary
to verify whether, if the manufacturer has chosen to apply the relevant
standards, these have actually been applied;
4.4. agree with the applicant on the place where the necessary examinations
and tests will be carried out.
5. If the type conforms to the provisions of this Directive, the notified body
shall issue the applicant with an EC type-examination certificate. The
certificate shall contain the name and address of the manufacturer, the
conclusions of the examination, the conditions of validity and the data
needed for identification of the type approved. The relevant parts of the
documentation shall be annexed to the certificate and a copy shall be
kept by the notified body.
6. The manufacturer shall inform the notified body without delay if it has
obtained information about changes to the pathogen and markers of
infections to be tested, in particular as a consequence of biological
complexity and variability. In this connection, the manufacturer shall
inform the notified body whether any such change is likely to affect the
performance of the in vitrodevice concerned.
6.1. Changes to the approved device 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 of the
Directive or with the conditions prescribed for use of the device. The
applicant shall inform the notified body which issued the EC type-exam-
ination certificate of any such change made to the approved device. This
new approval shall take the form of a supplement to the initial EC type-
examination certificate.1998L0079 — EN — 20.11.2003 — 001.001 — 34
▼B
7.Administrativeprovisions
Other notified bodies may obtain a copy of the EC type-examination
certificates and/or the supplements thereto. The annexes to the certifi-
cates must be available to the other notified bodies on reasoned
application, after the manufacturer has been informed.1998L0079 — EN — 20.11.2003 — 001.001 — 35
▼B
ANNEX VI
ECVERIFICATION
1. EC verification is the procedure whereby the manufacturer or his
authorised representative 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.
2.1. 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 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 sterilisation and the suitability of starting
materials, where necessary, and define the necessary testing procedures
according to the state of the art. All the routine, pre-established provi-
sions must be implemented to ensure homogeneous production and
conformity of the products with the type described in the EC type-exam-
ination certificate and with the requirements of this Directive which
apply to them.
2.2. To the extent that for certain aspects the final testing according to
section 6.3 is not appropriate, adequate process testing, monitoring and
control methods shall be established by the manufacturer with the
approval of the notified body. The provisions of Annex IV, section 5,
shall apply accordingly in relation to the abovementioned approved
procedures.
3. The manufacturer must undertake to institute and keep up to 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 and notification action as referred to in Annex III,
section 5.
4. The notified body must carry out the appropriate examinations and tests
taking account of section 2.2 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. When carrying out statistical verification
according to section 6, the notified body has to decide when statistical
procedures for lot-by-lot inspection or isolated lot inspection have to be
applied. Suchdecision must be taken in consultation withth e manufac-
turer.
In as far as the conduct of examinations and tests on a statistical basis is
not appropriate, examinations and tests may be carried out on a random
basis provided that such procedure in conjunction with the measures
taken in accordance withsection 2.2 ensures an equivalent level of
conformity.
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 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 eachapproved 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. One or more random samples, as necessary, are taken from eachbatch .
The products which make up the sample are examined and the appro-
priate 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-exam-
ination certificate and with the requirements of the Directive which apply
to them in order to determine whether to accept or reject the batch.1998L0079 — EN — 20.11.2003 — 001.001 — 36
▼B
6.3. Statistical control of products will be based on attributes and/or vari-
ables, entailing sampling schemes with operational characteristics which
ensure a high level of safety and performance according to the state of
the art. The sampling scheme will be established by the harmonised stan-
dards 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 iden-
tification number to eachproduct 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 the 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.1998L0079 — EN — 20.11.2003 — 001.001 — 37
▼B
ANNEX VII
ECDECLARATIONOFCONFORMITY
(PRODUCTION QUALITY ASSURANCE)
1. The manufacturer must ensure application of the quality system approved
for the manufacture of the devices concerned and carry out the final
inspection, as specified in section 3, and is subject to the 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 meet the provisions of this
Directive which apply to them.
The manufacturer must affix the CE marking in accordance with Article
16 and draw up a declaration of conformity covering the devices
concerned.
3.Qualitysystem
3.1. The manufacturer must lodge an application for assessment of his quality
system witha notified body.
— The application must include:
— the technical documentation on the types approved and a copy of the
EC type-examination certificates.
3.2. Application of the quality system must ensure that the devices conform
to the type described in the EC type-examination certificate.
All the elements, requirements and provisions adopted by the manufac-
turer 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 organisation of the business and in particular:
— the organisational structures, the responsibilities of the manage-
rial staff and their organisational authority where quality of
manufacture of the devices is concerned,
— 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 devices 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 sterilisation,
— the procedures in relation to purchasing,
— 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 the test equipment used; it must be possible to trace back the
calibration.
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 harmonised standards
conform to these requirements.
The assessment team must have past experience of assessments of the
technology concerned. The assessment procedure must include an inspec-
tion 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 must be notified to the manufacturer. It must contain the
conclusions of the inspection and a reasoned assessment.1998L0079 — EN — 20.11.2003 — 001.001 — 38
▼B
3.4. The manufacturer shall 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. It must notify the manufacturer of its decision.
This decision must contain the conclusions of the inspection and a
reasoned assessment.
4.Surveillance
The provision of Annex IV, section 5, shall apply.
5.Verificationofmanufacturedproductscovered byAnnexII,ListA
5.1. In the case of devices covered by Annex II, List A, the manufacturer
shall forward to the notified body without delay after the conclusion of
the controls and tests the relevant reports on the tests carried out on the
manufactured devices or each batch of devices. Furthermore, the manu-
facturer shall make the samples of manufactured devices or batches of
devices available to the notified body in accordance with pre-agreed
conditions and modalities.
5.2. The manufacturer may place the devices on the market, unless the noti-
fied body communicates to the manufacturer within the agreed time-
frame, but not later than 30 days after reception of the samples, any
other decision, including in particular any condition of validity of deliv-
ered certificates.1998L0079 — EN — 20.11.2003 — 001.001 — 39
▼B
ANNEX VIII
STATEMENT AND PROCEDURES CONCERNING DEVICES FOR
PERFORMANCEEVALUATION
1. For devices for performance evaluation the manufacturer or his authorised
representative shall draw up the statement containing the information stipu-
lated in section 2 and ensure that the relevant provisions of this Directive
are met.
2. The statement shall contain the following information:
— data allowing identification of the device in question,
— an evaluation plan stating in particular the purpose, scientific, technical or
medical grounds, scope of the evaluation and number of devices
concerned,
— the list of laboratories or other institutions taking part in the evaluation
study,
— the starting date and scheduled duration for the evaluations and, in the
case of devices for self-testing, the location and number of lay persons
involved,
— a statement that the device in question conforms to the requirements of
the Directive, apart from the aspects covered by the evaluation and apart
from those specifically itemised in the statement, and that every precau-
tion has been taken to protect the health and safety of the patient, user
and other persons.
3. The manufacturer shall also undertake to keep available for the competent
national authorities the documentation allowing an understanding of the
design, manufacture and performances of the product, including the expected
performances, so as to allow assessment of conformity withth e requirements
of this Directive. This documentation must be kept for a period ending at
least five years after the end of the performance evaluation.
The manufacturer shall take all the measures necessary for the manufacturing
process to ensure that the products manufactured conform to the documenta-
tion mentioned in the first paragraph.
4. The provisions of Article 10(1), (3) and (5) shall apply to devices intended
for performance evaluation.1998L0079 — EN — 20.11.2003 — 001.001 — 40
▼B
ANNEX IX
CRITERIAFORTHEDESIGNATIONOFNOTIFIEDBODIES
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 authorised 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 technicalinformation 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. The notified body shall
keep at the disposal of the national authorities the relevant documents asses-
sing 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 III to VII 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. This includes the availability of sufficient
scientific staff within the organisation who possess adequate experience and
knowledge necessary to assess the biological and medical functionality and
performance of devices for which it has been notified, in relation to the
requirements of this Directive and, in particular, with Annex I requirements.
The notified body must also have access to the equipment necessary for the
verifications required.
4. The inspection staff 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 suchinspections,
— the ability required to draw up the certificates, records and reports to
demonstrate that the inspections have been carried out.
5. The impartiality of the inspection staff must be guaranteed. Their remunera-
tion 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 inspection 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) under this Directive or any provision of national
law putting it into effect.1998L0079 — EN — 20.11.2003 — 001.001 — 41
▼B
ANNEX X
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.1998L0079 — EN — 20.11.2003 — 001.001 — 42