COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 19.04.1995 
COM(95) 130 final 
95/0013 (COD) 
Proposal for a 
EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 
on in vitro diagnostic medical devices 
Draft 
DECISION OF THE EEA JOINT COMMITTEE 
amending Annex II, technical regulations, standards, testing and certification, 
to the Agreement on the European Economic Area 
Draft common position of the Community 
(presented by the Commission) 
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EXPLANATOR Y MEMORANDUM 
I. GENERAL CONTEXT 
As part of the programme to complete the internal market, the rules for placing 
medical devices on the market are being harmonized throughout the Community 
to protect patients, users and third parties. Most medical-devices are covered 
already by the Directives on active implantable medical devices (90/385/EEC)1 
and on medical devices (93/42/EEC).2 
In vitro diagnostic medical devices were defined as medical devices in 
Directive 93/42/EEC but, in view of their special nature, were excluded from 
the abovementioned Directives. They are covered by this proposal. "In vitro 
diagnostic medical device" means, essentially, reagents, instruments and 
equipment for examining tissues or substances from the human body for 
medical purposes. 
Unlike medicinal products, which are administered to the*human body, in vitro 
diagnostic devices are used outside the human body for medical examinations of 
samples taken from the patient. These devices are therefore important tools for 
diagnosing illnesses, monitoring patients' state of health, checking the progress 
of courses of treatment and a whole series of other medical applications (for 
example, AIDS, hepatitis and glucose tests, pregnancy tests, tests for congenital 
abnormalities, etc.). Any malfunctioning of these devices could lead to 
misdiagnosis, in some cases with grave consequences for the health and 
treatment of the patients or for third parties who could be infected by contagious 
diseases. 
OJNoL 189,20.7.1990, p. 17. 
, OJNoL 169, 12.7.1993, p. 1. 
4 
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These devices are used mainly by medical laboratories, doctors and 
pathologists. A growing proportion, however, are intended to be used by the 
patients themselves (for example, glucose or pregnancy tests). 
The public interest covered by this proposal concerns the reliability, 
performance and precision of the devices in their medical application. In 
addition, the Directive provides protection for the health and safety of 
professional or private users and third parties against the risks inherent in the 
devices. 
Unlike the other medical devices already covered by Directives 90/385/EEC 
and 93/42/EEC, in vitro diagnostic devices do not usually enter into contact 
with the patient. To take account of this unique feature and of the different 
risks posed compared with other medical devices, this Directive covers such 
devices to complement the existing legislation in this sector. 
This proposal for a Directive is based on Article 100a of the Treaty. 
Furthermore, it takes into account Article 129 of the Treaty which stipulates 
that Community action shall be directed towards the prevention of diseases and 
that health protection requirements shall form one constituent part within other 
Community policies. 
It applies the principles of the new approach to technical harmonization. The 
proposal lays down the essential requirements which devices placed on the 
market must meet and the conformity assessment procedures with which 
manufacturers must comply. 
Before drafting this proposal, the Commission ordered a comparative study of 
the national legislation on such devices (cf. Section III). Its findings, together 
with the broad-based consultations held since 1991 with experts from the 
Member States, industrial circles and users, confirmed the need for this 
Directive and paved the way for drafting it. 
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H. ECONOMIC IMPORTANCE OF THE SECTOR 
Estimates put total worldwide production of medical devices, of which in vitro 
diagnostic devices are one subsector, at ECU 80 billion in 1993 (source: Health 
Industry Manufacturers' Association, HIMA). In 1993 the breakdown of 
production by country of origin was as follows: USA 52%; EC + EFTA 28% 
(EC 26%); Japan 18%. Since 1990 consumption has grown by 6% per year in 
the Community (by 7% in the USA in 1993 and by 6% in Japan). 
Some 50% of the Community market is supplied by the Community's own 
producers, 43% by US makers and 5% by Japanese manufacturers. In 1993 the 
estimated number of jobs provided by this industry in the EC stood at over 
240 000. 
Research is particularly important to the performance of this sector. According 
to sources in the industry, an average of 5.9% of its turnover is invested in 
research (EC 5%; USA 6.7%; Japan 6%). 
The in vitro diagnostic medical device subsector covered by this proposal 
accounts for between 16% and 18% of the total medical device market. This 
amounted to a total world market in these devices of some ECU 12.2 billion in 
1992 (source: European Diagnostics Manufacturers' Association, EDMA). In 
1992 the EC/EFTA took ECU 4.6 billion of this market, giving them a world 
market share of 38% (USA 39%; Japan 12%). 
European industry is highly developed in this subsector. It holds an extremely 
competitive position on the world market. An estimated 400 or so businesses, 
most of them medium-sized, are active in this field in the EC and EFTA 
countries. . Germany is the largest producer in Europe. France, the 
United Kingdom, Italy, Belgium and the Netherlands also have major 
industries.. 
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In vitro diagnostic medical device technology has developed rapidly over the 
last thirty years. 
The success of the technology is due, in particular, to the progress made with 
the development of scientific methods of analysis in the fields of chemistry, 
biochemistry and immunology, to the increase in the biological parameters 
available and to the combination of these data and methods with 
microelectronics, automation and information technology. Research activity in 
this industry is above average for the sector. Research accounts for between 15 
and 20% of the jobs in this subsector. 
m. LEGISLATION ON IN VITRO DIAGNOSTIC MEDICAL DEVICES AND 
EVALUATION OF THE NEED FOR LEGISLATION 
1. Existing legislation 
Before starting the harmonization work, in 1991 the Commission conducted a 
study to compare and analyse several Member States' national legislation on this 
subject. This revealed that the Member States' legislation differed not only in 
terms of the products covered but also on the detailed rules and the level of 
protection. Moreover, most of the legislation did not cover all the reagents, 
instruments, equipment and complete complex systems used for biomedicine, 
for which legislation is needed to provide an appropriate level of protection of 
health and safety. 
Based on the abovementioned study, the current situation as regards the 
Member States' legislation can be summed up as follows: 
* Some Member States have no legislation specifically on in vitro 
diagnostic devices, except on selected products which are particularly 
sensitive from the public health point of view. This is the case in the 
United Kingdom, Spain, Italy and the Netherlands where, in essence, 
tests to detect AIDS (HIV), tests on blood intended for transfusions or a 
few other specific reagents are monitored by the public authorities or 
subjected to special regulatory procedures before they can be placed on 
the market. 
* France recently adopted new legislation introducing a registration 
procedure to check the performance of reagents before they are placed 
on the market. Further inspections are required for certain categories of 
devices such as HIV tests, tests to determine blood groups and 
radioimmunoassays. 
* Belgium applies some of the rules for medicinal products to in vitro 
reagents too. c 
* In Germany the devices in question are governed by various regulations 
which call for stringent monitoring of some of them. Reagents are 
classified as medicinal products and are subject to controls calling for the 
application of good manufacturing practice. Several other groups of tests 
(immunological tests, particularly HIV tests, tests for hepatitis and tests 
for venereal diseases) have to pass an authorization procedure before 
they can be placed on the market. In addition, laboratory instruments 
and equipment used in this field are covered by the legislation on 
metrology and product safety. 
In conclusion, the study revealed big differences between the requirements 
imposed on the devices by the national regulatory systems, particularly with 
regard to labelling, authorization or registration procedures and production 
control. 
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In the USA, the Community's leading trading partner and the biggest producer, 
in vitro diagnostic devices (reagents, laboratory instruments and equipment for 
biomedicine) have been governed by the legislation on medical devices since 
1976. A series of special rules on, for example, labelling, manufacturing, etc. 
take account of the specific nature of these devices. The rules on good 
manufacturing practice are compulsory. 
2. European standardization 
Work already done by the European standardization bodies 
CEN/CENELEC will smooth the way for implementation of the future 
Community legislation. A number of "horizontal" standards on medical 
devices in general also apply to in vitro diagnostic devices and more 
specific work has been carried out on, for example, the information 
which must be supplied to users or on laboratory equipment. Some of 
this work has already been started in anticipation of this Directive. 
3. Evaluation of the need for harmonization 
There is a danger that the current differences between the national 
regulatory systems could deepen in the future. In particular, several 
Member States have already begun to legislate on in vitro diagnostic 
devices, notably when reorganizing their national legislation to 
implement Directives 90/385/EEC and 93/42/EEC on medical devices. 
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This has been confirmed by the cases of application or non-application of 
Directive 83/189/EEC on the notification of draft technical regulations.3 
Under this procedure the Commission has received notification of 
several national regulations concerning, in particular, the introduction of 
monitoring arrangements for HIV and hepatitis tests or for other tests 
(immunological and cancer tests). In one case the Commission had to 
apply Directive 83/189/EEC to block a draft national technical -
regulation for one year pending this proposal. 
The current disparities between the national systems, plus those which would 
follow with the adoption of further national legislation in the absence of 
European harmonization, create barriers to the free movement of these devices 
in the Community. The diverging requirements applied with regard to the 
devices covered and the monitoring procedures make it virtually impossible to 
establish any equivalence between the various national provisions in terms of 
health protection. For this reason, application of the principles of mutual 
recognition based on Article 30 of the Treaty/will be insufficient and 
inappropriate for removing and preventing barriers in this sector. Establishment 
of European standards by the CEN/CENELEC alone, without a regulatory 
framework, will not be enough to remedy the situation described above, given 
the voluntary nature of the standards. Consequently, harmonization of the 
legislation is the most appropriate means of ensuring free trade, all the more so 
since such Community legislation already exists for most other medical devices. 
OJ No L 109, 26.4.1983, p. 8, as last amended by Directive 94/10/EC of the 
European Parliament and the Council, OJ No L 100, 19.4.1994, p. 30. 
A 
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From the economic point of view, there is a danger that the lack of harmonized 
legislation could hamper the development of this industry in the Community. 
The diverging regulations force manufacturers to adapt their products to the 
situation on the individual national markets. They are therefore unable to 
s benefit from the Community market as their internal market. By contrast, 
harmonized conditions for placing products on the market would enable them to 
achieve economies of scale. Also, once manufacturers have adapted their 
products and processes to the Community legislation, they can expect the 
harmonization of legislation to cut the costs of complying with the regulations 
whicl\ are higher at the moment because of the need to comply with the varying 
national systems and procedures. 
The introduction of Community legislation taking account of the specific nature 
of the devices in question will generate added value for the development of the 
European industry and enable it to benefit more fully from the dimension of the 
internal market.. In contrast to the current situation, such legislation will create 
stable, foreseeable regulatory conditions and at the same time encourage the 
industry to proceed with research and make the necessary investments. In this 
way, it will contribute towards making the European industry more competitive 
on the world market. 
Finally, the Cqmmunity legislation will have an impact on trading relations with 
non-Community countries. Once this proposed Directive has been adopted, the 
Community will be able to use it in its international negotiations to improve 
access for the European industry to markets in third countries. 
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Since 1991 the Commission has organized several meetings to consult experts 
from the Member States, the industry and users on the results of the 
comparative analysis of the legislative systems in a number of Member States 
and the evaluation of the need for harmonization of the legislation and the 
content thereof* The conclusions drawn confirmed the Commission's view that, 
in view of the big differences between the national systems, of the obstacles to 
free trade and of their negative impact on industrial activity on the European 
market, harmonization of the legislation is necessary and will provide added 
value, both for protecting health and for the activities of the European industry 
concerned. In particular, all concerned have recognized the need for 
harmonization of the legislation. The consultations also showed that, as far as 
possible, this harmonization must complement and follow the same lines as the 
harmonization already completed for other medical devices. 
IV. JUSTIFICATION IN THE LIGHT OF THE SUBSIDIARITY PRINCIPLE 
1. What are the objectives of the proposed action in relation to the Community's 
obligations? 
As explained in Section III, the objective of this proposal for a Directive is: 
* to ensure free movement of in vitro diagnostic medical devices by 
harmonizing the national legislation on protection of the health and safety 
of patients, users and third parties; 
* to complete the existing Community legislation provided by 
Directives 90/385/EEC and 93/42/EEC on medical devices and to apply the 
same principles to in vitro diagnostic devices; 
* to create a favourable environment with uniform conditions of competition 
to enable the industry to benefit from the scale of the European Economic 
Area and to help make European industry more competitive. 
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2. Does competence for the planned activity lie solely with the Community? 
Exclusive competence, under Article 100a in conjunction with Article 7a of the 
Treaty. 
What forms of action are available to the Community? 
In view of the objectives of removing the barriers created by the diverging 
regulatory systems, of preventing new barriers and of establishing, a uniform, 
stable and foreseeable legal framework to protect the public interests concerned, 
the introduction of Community legislation is necessary. It must cover the 
manufacturing conditions, the protection requirements imposed on the devices, 
the conformity assessment procedures and the arrangements for monitoring the 
market. A Directive is the most appropriate instrument. As far as possible, the 
Directive will have to follow the principles already adopted for the rest of the 
industry in Directives 90/385/EEC and 93/42/EEC. 
Is it necessary to have a uniform regulation or is a Directive setting out the 
general objectives sufficient, leaving implementation at the level of the 
Member States ? 
A new approach Directive is proposed. It is confined to laying down the 
essential safety and performance requirements to be met by devices placed on 
the market and refers to voluntary European standards to be established by the 
CEN/CENELEC for technical formulation of these requirements. At the 
administrative level, implementation is reserved for the Member States. They 
will be responsible for monitoring the market and cooperating with the 
authorities in the other Member States. They will also appoint the certification 
bodies (notified bodies), depending on the availability of suitably qualified 
bodies, and monitor their activities. 
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V. CONTENT OF THE PROPOSAL 
1. Scope 
This proposal for a Directive governs the conditions for placing in vitro 
diagnostic medical devices on the market. It lays down the essential 
requirements in terms of the reliability of the devices, bearing in mind their 
intended purpose as tools for diagnostics and medical monitoring, and in terms 
of protection of users and third parties. The Directive also harmonizes the 
conformity assessment procedures to be applied by manufacturers before placing 
the devices on the market. The CE marking must be affixed to devices 
conforming with the requirements, which will be allowed to move freely 
throughout the internal market. 
In vitro diagnostic medical devices are a subcategory of medical devices, as 
already defined in Directive 93/42/EEC. They are devices used in medicine for 
the in vitro analysis of specimens from the human body. The medical 
applications include analyses of state of health (cholesterol or pregnancy tests), 
of diseases or congenital abnormalities, monitoring progress with a course of 
treatment (for example, dose and effect of medicinal products) or the 
establishment of compatibility in cases of organ or blood donations (for 
example, HIV and hepatitis tests). 
The vast majority of the products covered are intended for professional users, 
i.e. reagents, kits, instruments and equipment specifically for medical 
laboratories. The Directive also includes devices for self-testing which are used 
by patients or consumers in the home environment, for which it lays down 
special requirements to ensure that these devices can be easily used correctly by 
users with no particular knowledge of biological analysis. 
U 
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Control material and calibrators intended for use in combination with the 
abovementioned reagents and equipment are also considered to be in vitro 
diagnostic devices. 
The Directive will cover laboratory equipment only where it is Specifically 
intended for use in medical laboratories conducting in vitro examinations. 
The proposal does not apply to devices, in particular reagents, manufactured by 
laboratories for their own needs without any transaction with other users. It is 
left to the discretion of the Member States whether to require the appropriate 
monitoring for such activities. 
2. Essential requirements 
Devices placed on the market must comply with the essential requirements set 
out in Annex 1 to ensure a high level of protection of health and safety. They 
must be designed and manufactured to achieve the performances stated by the 
manufacturer and for use for the intended medical purpose, taking account of 
the generally acknowledged state of the artvThe essential requirements are also 
designed to protect users and third parties in particular against the risks posed 
by the physical and chemical properties of the devices and against the 
biological, mechanical, thermal, electrical and radiation risks posed by any 
energy source with which they are equipped. Devices for self-testing must be 
designed taking into account the skills and means available to users. Particular 
* attention must be paid to the clarity of the information and instructions 
accompanying the devices. 
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3. Conformity assessment procedures 
The conformity assessment procedures are based on Council Decision 
90/683/EEC,4 as amended by Council Decision 93/465/EEC.5 The proposal is 
aligned on the wording for these procedures in Directive 93/42/EEC, taking 
account of the specific nature of in vitro diagnostic medical devices and of 
manufacture thereof. 
(a) Devices placed on the market solely on the manufacturer's responsibility 
For an extremely large proportion of these devices, Article 9 and Annex 
3 of the proposal provide for the design and manufacture stages to be 
monitored on the manufacturer's responsibility, without the intervention 
of any third party. In view of the requirements imposed in order to 
control production and obtain products of reliable quality, manufacturers 
must follow the principles of quality assurance as appropriate for the 
devices manufactured. In addition, the technical documentation provided 
by the manufacturer must contain, inter alia, proof of the manufacturer's 
evaluation of the performance. 
(b) Devices requiring the intervention of a notified body 
Provision is made for the intervention of a notified body before devices 
for self-testing (Annex 3, point 6) and various categories of devices 
specified in Annex 2 are placed on the market. 
OJNoL380, 31.12.1990, p. 13. 
OJNo L 220, 30.8.1993, p. 23. 
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In the case of devices for self-testing, the intervention of a notified body 
is necessary as these devices are normally intended for persons with no 
experience of using them. For this reason, the notified body must 
concentrate on verification and on the performance of the devices under 
the conditions in which they would normally be used, taking account of 
the intended users. 
For the categories specified in Annex 2, i.e. tests for blood grouping and 
for the detection of HIV and hepatitis, Article 9 and Annexes 4, 5, 6 and 
7 provide for procedures requiring the intervention of a notified body. 
The notified bodies will certify the design and manufacture of such 
devices. In accordance with Decision 90/683/EEC on the certification 
modules, manufacturers may choose between product certification 
(Annexes 5 and 6), evaluation of the full quality assurance system 
(Annex 4) or an approach combining a type examination with a certified 
production quality assurance system (Annexes 5 and 7). 
These stringent procedures are-warranted by the fact that the tests in 
question are used particularly in the context of blood transfusions or 
organ transplants. Consequently, strict controls on these devices are 
essential to ensure reliable diagnosis. Moreover, HIV tests are targeted 
on AIDS, which must be combated with the most appropriate, effective 
means available in the interest of public health. 
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(c) Classification arid reclassification of devices 
The proposal allows amendment of the list of devices in Annex 2, with 
the assistance of a regulatory committee (cf. Article 12). This 
reclassification procedure could prove necessary, particularly where 
devices for new uses cannot provide sufficient guarantees of the 
reliability of their performance. In such cases, verification by a third 
party could be necessary on health protection grounds. 
For this reason, depending on their intended medical use, performance 
or characteristics, certain categories of device could, if necessary, be 
subjected to the appropriate conformity assessment procedures within the 
framework of this proposal. The rules on the conformity assessment 
procedures are a balanced reflection of the existing national legislation in 
this field. By reserving conformity assessment for a large proportion of 
devices for the manufacturers, the proposal takes account of the fact that 
these devices are intended for professional users. In addition, in most 
Member States-medical laboratories in turn are subject to outside quality 
assurance systems which will offer added controls. 
Finally, the proposal provides for mechanisms to monitor the market, 
notably via vigilance procedures. If application of these mechanisms 
indicates a need to tighten up the controls before certain devices are 
placed on the market, reclassification may be decided following the 
committee procedures. 
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4. Registration of manufacturers and vigilance procedure 
Article 10 of the proposal requires all manufacturers to inform the 
competent authorities of the Member State where they have their 
registered place of business of the categories of devices which they 
market. Manufacturers not established in the Community must designate 
an authorized representative to carry out the abovementioned 
notification. Notification is also required for new devices, as specified 
in the proposal. These rules enable the authorities to monitor the market 
and to take any measures necessary to protect the public interest. A 
network linking the authorities will therefore have to be established to 
make it easier to exchange data. Just as for the other medical devices 
covered by Directives 90/385/EEC and 93/42/EEC, this proposal 
introduces a vigilance procedure (Article 11). Under these rules, 
manufacturers will have to give notification of any malfunction of the 
devices which could affect patients' and users' health. The objective of 
this vigilance system is to prevent devices from remaining in circulation 
on the Community market if they display faults which could lead to the 
wrong medical decisions. This system reinforces the monitoring 
methods at the disposal of the competent authorities and encourages 
manufacturers to conduct the requisite investigations and make the 
necessary corrections to the devices concerned. Close cooperation 
between the national administrations will be essential in this system. 
Special arrangements for devices for performance evaluation 
Article 9(3) of the proposal makes special arrangements for in vitro 
diagnostic medical devices for performance evaluation. These apply to 
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devices intended for medical use of which the precise performance has 
yet to be verified and confirmed. In view of the objective of the 
evaluations, there is no need for such devices to comply with all the 
essential requirements. The status of these devices must be indicated on 
the label and the manufacturer must follow a special conformity 
procedure. 
Amendments to Directive 93/42/EEC concerning medical devices 
These amendments (Article 19(1)) concern the definition of "in vitro 
diagnostic medical device" in Directive 93/42/EEC. They would also 
extend the scope of Directive 93/42/EEC by adding devices 
incorporating tissues of human origin. At the time of the adoption of the 
Directive concerning medical devices, the Council asked the 
Commission to reexamine the situation with these devices and to propose 
the measures to be taken. Preparatory work on this subject has revealed 
that, at national level, either there is no legal cover for such devices or 
that they are governed by diverging classifications which could impair 
free movement. In view of the current legal uncertainty and of the 
inherent health hazards posed by these devices, the majority of the 
national experts recognize the need to make such devices subject to 
Directive 93/42/EEC. However, Directive 93/42/EEC will apply only 
to devices incorporating tissues which have been rendered non viable. 
The proposal will apply without prejudice to the national regulations 
relating to the ethics of collecting and using tissues of human origin, 
thereby taking account of the concerns expressed during the consultation 
phase. 
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Similar problems with the inclusion of devices incorporating tissues of 
human origin also arise in the case of in vitro diagnostic devices 
(including in the form of control materials in kits). Consequently, the 
proposed amendment to Directive 93/42/EEC will result in uniform rules 
for the entire sector. 
VI. RELEVANCE TO THE EUROPEAN ECONOMIC AREA 
This proposal falls into the field covered by the Agreement on the European 
Economic Area. The consultations included experts from the EFTA countries 
in the EEA. The proposal for a decision by the EEA Joint Committee 
extending the proposal for a Directive to the EEA is included in this dossier. 
12 
PROPOSAL FOR A DIRECTIVE OF THE EUROPEAN PARLIAMENT 
AND THE COUNCIL 
ON IN VITRO DIAGNOSTIC MEDICAL DEVICES 
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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 Commission1, 
Having regard to the opinion of the Economic and Social Committee2, 
Acting in accordance with the procedure referred to in Article 
189B of the Treaty establishing the^. European Community, 
Whereas measures should be adopted for the progressive 
establishment of the internal market; whereas the internal market 
is an area without internal frontiers in which the free movement 
of goods, persons, services and capital is ensured; 
Whereas the content and scope of the laws, regulations and 
administrative provisions in force in the Member States with 
regard to the safety, health protection and performance 
characteristics and authorization procedures for in vitro 
diagnostic medical devices are different; whereas the existence of 
such disparities constitute barriers to trade and the need to 
establish harmonised rules was confirmed by a comparative survey 
of national legislations carried out on behalf of the Commission; 
Whereas the harmonization of national legislations is the only 
means of removing these barriers to free trade and preventing new 
barriers; whereas " this objective cannot be achieved in a 
satisfactory manner at another level by the individual Member 
States; whereas this Directive only lays down necessary and 
sufficient requirements for the free circulation of the in vitro 
diagnostic medical devices to which it is applicable; 
Whereas tl\e harmonized provisions must be distinguished from the 
measures adopted by the 'Member States to manage the funding of 
public health and sickness insurance schemes relating directly or 
indirectly to such devices; whereas, therefore, the provisions do 
not affect the ability of the Member States to implement the 
abovementioned measures provided Community law is complied with; 
Whereas in vitro diagnostic medical devices should provide 
patients, users and third parties with a high level of protection 
and attain the performance levels attributed to them by the 
manufacturer; whereas,' /therefore, the maintenance or improvement 
of the level of protection attained in the Member States is one of 
the essential objectives of this Directive; 
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Whereas, in accordance with the principles set out in the Council 
resolution of 7 May 1985 concerning a new approach to technical 
harmonization and standardization3, rules regarding the design and 
manufacture of relevant products must be confined to the 
provisions required to meet the essential requirements; whereas, 
because they are essential, such requirements should replace the 
corresponding national provisions; whereas the essential 
requirements, including requirements to minimize and reduce risks, 
should be applied with discretion, taking into account the 
technology and practice at the time of design and of'technical and 
economic considerations compatible with a high level of protection 
of health and safety; 
Whereas the major part of medical devices are covered by Council 
Directive 90/385/EEC relating to active implantable medical 
devices4 and Council Directive 93/42/EEC relating to all other 
medical devices-"1 with the exclusion of in vitro diagnostic medical 
devices; the present Directive shall extend the harmonization to 
in vitro diagnostic medical devices; whereas, in the interest of 
uniform Community rules, this Directive is based largely on the 
provisions of Directives 90/385/EEC and 93/42/EEC; 
Whereas certified international reference materials and 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 devices are in vitro 
diagnostic medical devices; 
OJNo.C 136.4.6.1985. p. I 
OJ NoL 189. 20.7.1990. p. I 7 
OJNo. L 169, 12.7.1993. p. 1 
D -
Whereas reagents produced within user laboratories and which are 
not subject to commercial transactions, taking account of the 
principle of subsidiarity, are not included in this Directive; 
Whereas the electromagnetic compatibility aspects form an integral 
part of.the essential requirements of this- Directive, the Council 
Directive* 89/336/EEC of 3 May 1989 relating to electromagnetic 
compatibility 6 shall not apply; 
Whereas, in order to ease the task of proving conformity with the 
essential requirements and to enable conformity to be verified, it 
is desirable to have harmonized standards in respect of the 
prevention of risks associated with the design, manufacture and 
packaging of medical devices; whereas such harmonized standards 
are drawn up by private-law bodies and should retain their status 
as non-mandatory texts; whereas, to this end, the European 
Committee for Standardization (CEN) anpl the European Committee for 
Electrotechnical Standardization (CENELEC) are recognized as the 
competent bodies for the adoption of harmonized standards in 
accordance, with the general guidelines on cooperation between the 
Commission and these two bodies signed on 13 November 1984; 
Whereas, for the purpose of this Directive, a harmonized standard 
is a technical specification (European standard or Harmonization 
Document) adopted, on a mandate from the Commission, by either or 
both .of these bodies in accordance with Council ^ Directive 
83/189/EEC of 28 March 1983 laying down a procedure for the 
provision of information in the field of technical standards and 
regulations7, and pursuant to the abovementioned general 
guidelines; 
6 
7 OJ No. L 139, 23.5.1989. p. 19. Directive last amended by Directive 93/68/EEC (OJ No. L 220, 
30.8.1993, p. 1) 
OJ No. L 109, 26.4.1983, p. 8. Directive last amended by Directive 94/10/EC of the European 
Parliament and the Council (OJ No. L 100, 19.4.1994. p. 30) 
Whereas, in- Decision 90/683/EEC of 13 December 1990 concerning the 
modules for the various phases of the conformity assessment 
procedures which are intended to be used in the technical 
harmonization directives8, the Council has laid down harmonized 
conformity assessment procedures; whereas the details added to 
these modules are justified by the nature of the verification 
required for in vitro diagnostic medical devices and by the need 
for consistency with the previous directives on medical devices; 
Whereas it is necessary, essentially v for the purpose of the 
conformity assessment procedures, to group in vitro diagnostid. 
medical devices into two product classes; whereas, since the large 
majority of such devices do not constitute a direct risk to 
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 a general, 
rule, under the sole responsibility of the manufacturer; whereas, 
taking account of existing national regulations and of 
notifications received following the procedure of Directive 
83/189/EEC, the intervention of->•• natifled bodies is needed only for 
defined devices,, t'he correct performance of which is essential to 
medical practice and the failure of which can cause a serious risk 
to health; 
OJ No. L 380, 31.12.1990, p. 13, as last amended by Decision 93/465/EEC, OJ No. L 220, 30.8.1993, 
p. 23 
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Whereas the list of in vitro diagnostic medical devices to be 
subjected to third party conformity assessment needs updating,, 
taking account of technological progress and of evolution in the 
domain of protection of health; whereas such updating measures 
must be taken in line with the procedure Ilia as laid down in the 
Council Decision 87/373/EEC9; whereas a system of adverse incident 
reporting (vigilance) constitutes a useful tool for the 
surveillance of the market, including the performance of new 
devices; whereas information obtained from vigilance as Well as 
from external quality assessment schemes becomes useful for 
decision-making on classification of devices; 
Whereas medical devices should, as a general rule, bear the CE 
marking to indicate their conformity with the provisions of this 
Directive to enable them to move freely within the Community and 
to be put into service in accordance with their intended purpose; 
Whereas manufacturers shall have the possibility, when the 
intervention of a notified body is required, to choose amongst 
those bodies published by the Commission; whereas the Member 
States do' not have an obligation to designate such notified 
bodies, they must ensure however that bodies designated as 
notified bodies comply with the assessment criteria laid down in 
this directive; 
Whereas the competent authorities in charge of market surveillance 
must be able, particularly in emergencies, to contact the 
manufacturer or his authorized representative established in the 
Community; whereas cooperation and exchange of information between 
Member States are necessary in view of uniform application of this 
Directive, in particular for the purpose of market surveillance; 
OJno. L 197. 18.7.1987. o. 23 
-8-
Whereas this Directive includes •in vitro diagnostic medical 
devices incorporating substances derived from the human body, it 
does not affect national regulations relating to the ethics of use 
of such substances; whereas for the purpose of overall consistency 
between medical devices directives, the Directive 93/42/EEC needs 
to be amended accordingly;' 
HAVE ADOPTED THIS DIRECTIVE : 
Article 1 
Scope, Definitions 
This Directive shall apply to in vitro diagnostic medical 
devices and their accessories. For the purposes of this 
Directive, accessories shall be treated as in vitro 
diagnostic medical devices in their own right. Both in vitro 
diagnostic medical devices and accessories shall hereinafter 
be termed devices. 
For the purpose of this Directive, the following definitions 
shall apply : 
(a) "medical device" means any instrument, apparatus, 
appliance, material 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 
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; 
-10-
(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 used alone or in combination, intended 
by the manufacturer to be used in vitro for 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 state, state of health or 
disease or congenital abnormality or to determine the 
safety and compatibility with potential recipients. 
For the purpose of this directive, a specimen receptacle, 
whether evacuated or not, specifically intended by its 
manufacturer to contain a specimen for the purpose of in 
vitro diagnostic examination is considered to be a 
device; 
Products for general laboratory use are not devices 
unless such products, in view of their characteristics, 
are specifically 'intended by their manufacturer to be 
used for in vitro diagnostic examination; 
(c) "accessory" means an article which, whilst not being a 
device in the meaning of paragraph 2(b), is intended 
specifically by its manufacturer to be used together 
with a device to enable this device to be used in 
accordance with its intended purpose; 
(d) "Device for self-testing" means any device intended by 
the manufacturer to be used in the home environment; 
-li­
fe) "Device for performance evaluation" means any device 
intended by the manufacturer to be subject to one or 
more performance evaluation studies in clinical 
laboratories or in * other appropriate environments 
outside his own premises; 
(f) "manufacturer" means the natural. or legal person with 
responsibility for the design, manufacture, packaging 
and labelling of a device before it is placed on the 
market under his own name, regardless of whether these 
operations are carried out by thafr 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-made products . and/or 
assigns to them their intended purpose as devices with a 
view to their being placed on the market, under his own 
namej 
(g) "authorized representative" means the natural . or legal 
person established within the Community who, being 
explicitely designated by the manufacturer, acts and may 
be addressed by authorities and bodies in the Community 
in substitution for the manufacturer, with regard to the 
latter's obligations in accordance with 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; 
-12-
(i) "placing on the market" means the first making available 
in return for payment or free of charge of a device with 
a 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 
is ready for use on the Community market for the first 
time for its intended purpose; 
(k) "calibrator", "control material" mean any substance, 
material or article intended , by its manufacturer to 
establish and/or verify performance characteristics of a 
device in conjunction with the use of" that device; 
Where à device incorporates tissues or substances of human 
origin, this directive shall not affect national regulations 
relating to the ethics of the collection of tissues or 
substances of human origin as well as any regulations 
relating to the ethics governing distribution of given types 
of devices of such origin. 
-13-
4. This Directive shall not apply to devices manufactured and 
used only within the same institution and on the premises of 
their manufacture. This does not^affect the right of Member 
States to subject such activities to appropriate protection 
requirements. 
5. This Directive is a specific directive within the meaning of 
Article 2(2) of the Directive 89/336/EEC10.. 
10 . Article 2 
Placing on the market and putting into service 
Member States shall take all necessary steps to ensure that 
devices may be placed on the market and put into service only 
if they comply with the requirements laid down in this 
Directive when properly installed, maintained and used in 
accordance with their intended purpose. 
Article 3 
Essential requirements 
Devices must meet the essential requirements set out in Annex 
1 which apply to them, taking account of the intended purpose 
of the devices concerned. 
Council Directive 89/336/EEC relates to electromagnetic compatibility. OJ No. L J39, 23.5.1989, p. 19; 
as last amended by Directive 93/ 68 /EEC (OJ no L 220, 30.8.1993, p. 1) 
i \ 
-14-
Article 4 
Free movement 
Member States shall not create any obstacle to the placing on 
the market or the putting into service within their territory 
of devices bearing the CE-marking provided for in article 14 
or labelled as devices for performance evaluation if these 
devices have been the subject of an assessment of their 
conformity in accordance with the provisions of article 9. 
2. At trade fairs, exhibitions, demonstrations, Member States 
shall not create any obstacle to the showing of devices which 
do not conform to this Directive, provided that a visible 
sign clearly indicates that such devices cannot be marketed 
or put into -service until they have been made to comply. 
3. Member States may require, when a device reaches the final 
user, information, as referred to in Annex 1 point 13, to be 
in their national language(s) or in other Community 
language (s) to the extent that it is needed for safe and 
correct use of the device. In the application of this 
provision Member States shall take into account the principle 
of proportionality and in particular whether information can 
be provided by recognised symbols or codes and whether the 
device is intended for use by trained professionals. 
-15-
4. Where the devices are subject to other Directives concerning 
other aspects and which also provide for the affixing of the 
CE marking, the latter shall indicate that the devices also 
fulfil the provisions of the other Directives. 
However, should one or more of these directives allow the 
manufacturer, during a» transitional period, to choose which 
arrangements to apply, the CE marking shall indicate that the 
devices fulfil the provisions only of those directives 
applied by the manufacturer. In this case, the particulars of 
these directives, as published in the Official Journal of the 
European Communities, must be given in the documents, notices 
or instructions required by the directives and accompanying 
such devices. 
Article 5 
Reference to standards 
I9 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 
which transpose the harmonized standards the reference of 
which have been published in the Official Journal of the 
European Communities; Member States shall publish the 
references of such national- standards 
/If the Member State or the Commission considers that the 
harmonized standards do not entirely^ meet the essential 
requirements referred to in Article 3, the measures to be 
taken with regard to these standards and the publication 
referred to in paragraph 1 of this Article shall be adopted 
by the procedure defined in Article 6(2) 
• - 16-
Article 6 
Committee on Standards and Technical Regulations 
1. The Commission shall be assisted by the Committee set up by 
Article 5 of Directive 83/189/EEC. 
The representative of the Commission shall submit to the 
Committee a draft of the measures to be taken. The Committee 
shall deliver its opinion on the draft within a time limit 
which the chairman may lay down according to the urgency of 
the matter, if necessary by taking a vote. 
The opinion shall be recorded in the minutes; in addition, 
each Member State shall have the right to ask to have its 
position recorded in the minutes. 
The Commission shall take the utmost account of the opinion 
delivered by the Committee. It shall inform the Committee of 
the manner in which its opinion has been taken into account. 
Article 7 
Committee on Medical Devices 
The Commission shall be assisted by the Committee set up by 
Article 6(2) of Directive 90/385/EEC. 
Ziv 
-17-
The representative of the Commission shall submit to the 
Committee a draft of the measures to be taken. The Committee 
shall deliver its opinion on the draft within a time limit 
which the chairman may lay down according to the urgency of 
the matter. The opinion shall be delivered by the majority 
laid down in Article 148(2) of the Treaty in the case of 
decisions which the Council is required to adopt on a 
proposal from the Commission. The votes of the 
representatives of the Member States within the Committee 
shall be weighted in the manner set out in that- Article. The 
chairman shall not vote. 
The Commission shall adopt the measures envisaged if they are 
in accordance with the opinion of the Committee. 
If the measures envisaged are not in accordance with the 
opinion of the Committee, or if no opinion is delivered, the 
Commission shall, without delay, submit to the Council a 
proposal relating to the measures to be taken. The Council 
shall act by a qualified majority. 
If, on the expiry of a period of three months from the date of 
referai to the Council, the Council has not acted, the 
proposed measures shall be adopted by the Commission 
The Committee referred to in paragraph 1 may examine any 
'question connected with the implementation of this Directive. 
-18-
Article 8 
Safeguard clause 
Where a Member State ascertains that the devices referred to 
in Article 4(1), when correctly installed, maintained and 
used for their intended purpose may compromise the health 
and/or safety of patients, users or, where applicable, other 
persons, and the safety of property, it shall take all 
appropriate interim measures to withdraw such devices from 
the market or prohibit or restrict their being placed on the 
market or put into service. The Member State shall 
immediately inform the Commission of any such measures, 
indicating the reasons for its decision and, in particular, 
whether non-compliance with this Directive is due to: 
(a) failure to meet the essential requirements referred to 
in Article 3; 
(b) incorrect application of the standards referred to in 
Article 5, in so far as it is claimed that the standards 
have been applied; 
(c) shortcomings in the standards themselves. 
2. The Commission shall enter into consultation with the parties 
concerned as soon as possible. Where, after such 
consultation, the Commission finds that: 
-19-
the measures are justified, it shall immediately so inform 
the Member State which took the initiative and the other 
Member States; where the decision referred to in 
paragraph 1 is attributed to shortcomings in the standards, 
the Commission shall, after consulting the parties 
concerned, bring the matter before the committee referred 
to in "Article '6 (1) within two months if the Member State 
which has taken the decision intends to maintain it and 
shall initiate the procedures referred to in Article 6; 
the measures are unjustified, it shall immediately so 
inform the Member State which took the initiative and the 
manufacturer or his authorized representative established 
within the Community. 
3. Where a non-complying device bears the CE marking, the 
competent Member State shall take appropriate action against 
whomsoever has affixed 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 
Conformity assessment procedures 
1. For all devices other than those covered by Annex 2 and 
devices for performance evaluation, the manufacturer shall, 
in order to affix the CE marking, follow the procedure 
referred to in Annex 3 and draw up the EC declaration of 
conformity required before placing the' devices on the market. 
-20-
For all devices for self-testing the manufacturer shall, 
prior to the drawing up of the .aforementioned declaration of 
conformity, fulfil the supplementary requirements set out in 
Annex 3 point 6. Instead of applying this procedure, the 
manufacturer may also follow the procedure referred to in 
paragraph 2. 
2. For all devices covered by Annex 2 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 4 (full quality assurance) 
or 
;b) follow the procedure relating to EC type examination set 
out in Annex 5 coupled with : 
(i) the procedure relating to EC verification set out 
in Annex 6, or 
(ii) the procedure relating to the EC declaration of 
conformity set out in Annex 7 (production quality 
assurance) 
In the case of devices for performance evaluation, the 
manufacturer shall follow the procedure referred to in Annex 
8 and draw up the statement set out in that Annex before 
placing such devices on the market. 
-21-
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 at an intermediate stage of 
manufacture. 
5. The manufacturer may instruct his authorized representative 
established in the Community to initiate the procedures 
provided for in Annexes 3, 5, 6 and 8. 
6. The manufacturer must keep the declaration of conformity, the 
technical documentation referred to in Annexes 3 to 8, as 
well as the 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 manufactured. Where 
the manufacturer is not established in the Community, the 
obligation to make the aforementioned documentation available 
on request applies to his authorized representative 
established within the Community. 
7. Where the conformity assessment procedure involves the 
intervention of a notified body, the manufacturer, or his 
authorized representative established in the Community, may 
apply to a body of his choice within the framework of the 
tasks for which the body has been notified. 
-22-
8. The notified body may require, where duly justified, any 
information or data, which is necessary for establishing and 
maintaining the attestation of conformity in view of the 
chosen procedure. 
9. Decisions taken by the notified bodies in accordance with 
Annexes 3, 4 and 5 shall be valid for a maximum of five years 
and may be extended on application, made at a t.ime agreed in 
the contract signed by both parties, for further periods of 
V 
five years. 
10. The records and correspondence relating to the procedures 
referred to in paragraphs 1 to 3 shall be in one of the 
official languages of the European Community and in the case 
of involvement of a notified body in a Community language 
acceptable to the notified body. 
11. By derogation from paragraphs 1 to 3, the competent 
authorities may authorize, "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 procedures referred to in paragraphs 1 
to 3 have not been carried out and the use of which is in the 
interest of protection of health. 
- 23 -
Article 10 
Registration of manufacturers 
Any manufacturer, who places devices on the market under his 
own name, shall notify the competent authorities of the 
Member State in which he has his registered place of business 
of the address of the registered place of business, the 
categories of devices as defined in terms of common 
characteristics of technology and/or analytes • and of any 
significant change thereto. The before mentioned notification 
shall also include any new device as referred to in Article 
11(4). 
2. Where a manufacturer, who places devices 'on the market under 
his own name, does not have a registered place of business in 
a Member State, he shall designate an authorized 
representative established in the Community. The authorized 
representative shall inform the competent authorities of the 
Member State, in which he has- his registered place of 
business, of all particulars as referred to in paragraph 1. 
3. The Member States shall on request inform the other Member 
States and the Commission of the details referred to in 
paragraphs 1 and 2. The procedures implementing the present 
Article shall be adopted in accordance with the procedure 
referred to in Article 7(2). 
-24-
Article 11 
Vigilance 
Member States shall take the necessary steps to ensure that 
any information brought to their knowledge, in accordance 
with the provisions of this Directive, regarding the 
incidents mentioned below involving devices bearing 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 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 to a 
serious deterioration in his 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 organizers of external quality 
assessment schemes to inform the competent authorities of any 
incidents referred to in paragraph 1, it shall take the 
necessary steps to ensure that the manufacturer of the device 
concerned, or his authorized representative established in 
the Community, is also informed of the incident. 
-25-
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 relevant measures have been taken or are contemplated. 
4. Where, in the context of notification referred to in Article 
1.0, a device notified, bearing a CE marking, is a "new" 
product, the manufacturer 'shall indicate this fact on his 
notification. The competent authority so notified may at any 
time within the following two years and on justified grounds, 
require the manufacturer to submit a report relating to the 
experience with the device subsequent to its being placed on 
the market. For this purpose, a device is "new" if : 
(a) such a device, for the relevant analyte or other 
parameter, has not been continuously available on the 
Community market during the previous three years, 
(b) the procedure involves analytical technology not used in 
connection, with a given analyte or other parameter on 
the Community market continuously during the previous 
three years. 
5. The Member States shall on request inform the other Member 
States of the details referred to in paragraphs 1 and 4. The 
procedures implementing the present Article shall be adopted 
in accordance with the procedure referred to in Article 7(2). 
-26-
Article. 12 
Modification of Annex 2, derogation clause 
1. Where a Member State considers that : 
(a) the list of devices covered by Annex 2 should be 
modified or extended, or 
(b) the conformity of a device or a category of devices 
should be established by way of derogation from the 
provisions of Article 9, by applying one or several 
alternative 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 in accordance with Article 7(2). 
2. When a measure is to be taken in accordance with paragraph 1, 
due consideration shall be given : 
(a) to any relevant information available from the vigilance 
procedures and from external quality assessment schemes 
as referred to in Article 11 
(b) to the following criteria 
(i) whether total reliance has to be put on the result 
obtained with a given device, having a direct 
impact on the subsequent medical action, and 
- 27 -
ii) whether an action taken on the basis of an 
incorrect result obtained using a given device 
could prove to be hazardous to the patient or third 
party as a consequence of false positive or false 
negative results, and 
;iii) whether the involvement of a notified body is 
appropriate and justified. 
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 13 
Notified bodies 
Member States shall notify the Commission and other Member 
States of the bodies which they have designated for carrying 
out the tasks pertaining to the procedures referred to in 
Article 9 and the specific tasks for which the bodies have 
been designated. The Commission shall assign identification 
numbers to these bodies, hereinafter referred to as "notified 
bodies". 
-28-
The Commission shall publish a list of the notified bodies, 
together with the identification numbers it has allocated to 
them and the tasks for which they have been notified, in the 
Official Journal of the European Communities. It shall ensure 
that the list is kept up to date. 
2. Member States shall apply the criteria set out in Annex 9 for 
the designation of bodies. Bodies that meet the criteria laid 
down in the national standards which transpose the relevant 
harmonised standards shall be presumed to meet the relevant 
criteria. 
A Member State that has notified a body shall withdraw that 
notification if it finds that the body no longer meets the 
criteria referred to in paragraph 2. It shall immediately 
inform the other Member States and the Commission of any 
withdrawal of notification for the aforementioned or any 
other reason. 
The notified body and the manufacturer, or its authorized 
representative established in the Community, shall lay down, 
by common accord, the time limits for completion of the 
assessment and verification operations referred to in Annexes 
3 to 7. 
5. The notified body must make available to the other notified 
bodies and the competent authority, on request, all relevant 
information concerning approvals and certificates issued, 
refused or withdrawn. 
-29-
Article 14 
CE-marking 
1. Devices, other than devices for performance evaluation, 
considered to meet the essential requirements referred to in 
Article 3 must bear the CE marking of conformity when they 
are placed on the market. 
2: The CE-marking of ^conformity, as shown in Annex 10, must 
appear in a visible, legible and indelible form on the 
device, where practicable and appropriate, and on the 
instructions, for use. Where applicable the CE "marking 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 out in Annexes 4, 6 and 7. 
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 device provided that the visibility and 
legibility of the CE marking is not thereby reduce. 
u^r '-i 
-30-
Article 15 
Unduly affixed CE marking 
Without prejudice to Article 8 : 
a) where a Member State establishes that the CE marking has been 
affixed unduly, the manufacturer or his authorized 
representative established within the Community shall be 
obliged to end 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. 
Article 16 
Decisions in respect of refusal or restriction 
1. Any decision taken pursuant to this Directive : 
(a) to refuse or restrict the placing on the market or the 
putting into service of a device or 
(b) to withdraw devices from the market 
-31-
shall state the exact grounds on which it is based. Such 
decisions shall be notified without delay to the party 
concerned, who shall at the same time be informed of the 
remedies available to him under the national law in force in 
the Member State in question and of the time limits to which 
such remedies are subject. 
2. In the event of a decision as referred to in paragraph 1, the 
manufacturer, or his authorized representative established in 
the Community, shall have an opportunity to put forward his 
viewpoint in advance, unless such consultation is not 
possible because of the urgency of the measure to be taken. 
Article 17 
Confidentiality 
Without prejudice . to the existing national provisions and 
practices on medical secrets, Member States shall ensure that all 
the parties involved in the application of this Directive are 
bound to observe confidentiality with regard to information 
obtained in carrying out their tasks. This does not affect the 
obligations of Member States and notified bodies with regard to 
mutual information and the dissemination of warnings, nor the 
obligations of the persons concerned to provide information under 
criminal law. 
J.°V 
-32-
Article 18 
Cooperation between Member States 
Member States shall take appropriate measures to ensure that 
competent authorities charged with the implementation of the 
present Directive cooperate with each other and convey to each 
other the information necessary to ensure compliance with the 
provisions of this Directive. 
Article 19 
Amendment of--Directives 
Directive 93/42/EEC is hereby amended as follows : 
a) Article 1(2) c) shall read as follows : 
" (c) in vitro diagnostic medical device means any medical 
device which is a reagent, reagent product, calibrator, 
control material, kit, instrument, apparatus, equipment or 
system whether used alone or in combination, intended by the 
manufacturer to be used in vitro for 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 state, state 
of health or disease or congenital abnormality or to determine 
the safety and compatibility with potential recipients". 
Cf) 
-33-
b) Article l(5)f shall read as follows : 
"(f) transplants or tissues or cells of human origin, 
unless a device is manufactured utilizing tissues or 
substances derived from such tissues which are non viable 
or rendered non viable. In this case, the directive shall 
not affect national regulations relating to the ethics of 
the collection of tissues or substances of human origin, 
as well as any regulations relating to the ethics 
governing distribution of given types of devices of such 
origin." 
c) Annex I, paragraph 8.2, shall read as follows : 
"8.2.Where a device is manufactured utilizing human 
tissues or substances derived from human tissues, the use 
of such tissues or substances must be subject to the 
relevant validated selection and screening procedures, 
including traceability as appropriate in relation to the 
inherent risk. 
Tissues of animal origin must originate from animals that 
have been subjected to veterinary controls and 
surveillance adapted to the intended use of the tissues. 
Processing, preservation, testing .and handling of 
tissues, cells and substances of human or animal origin 
must be carried out so as to provide optimal security. In 
particular safety with regard to viruses and other 
transmissible agents must be addressed as appropriate by 
implementation of validated' methods of elimination or 
inactivation of such viruses or other transmissible 
agents in the course of the manufacturing process, taking 
into account the sourcing and control methods applied." 
- 34 -
d) Annex I paragraph 13.3 shall be completed by the 
following subparagraph : 
"n) in the case of devices incorporating tissues of 
human origin or substances derived from such tissues, a 
statement indicating that the device incorporates tissue 
or substances derived from tissue of human origin as 
appropriate" 
e) In annex II paragraph 3.2c) and annex III paragraph 3 the 
following indent shall be included as third last indent : 
"in the case of devices incorporating tissues of human or 
animal origin, information on the selection and origin" 
f) Annex IX, section III, paragraph 4.5 : the following sub­
paragraph shall be added : 
"All devices manufactured utilizing human tissues or 
substances derived from such tissues are in class III." 
2. In Directive 89/392/EEC, the text of Article 1(3), second 
indent " machinery for medical use, used in direct contact 
with patients" is replaced by the following text : 
"- medical devices" 
4C°> 
- 35 -
Article 20 
Implementation, transitional provisions 
Member States shall adopt and publish the laws, regulations 
and administrative provisions necessary to comply with this 
Directive- not later than 1 April 1998. They shall immediately 
inform the Commission thereof. 
The Standing Committee referred to in Article 7 may assume its 
tasks from the date of notification of this Directive. The 
Member States may take the measures referred to in Article 13 
on notification of this Directive. 
When Member States adopt these provisions, these shall contain 
a reference to this1Directive or shall be accompanied by such 
a reference at the time of their official publication. The 
procedures for such reference shall be adopted by Member 
States. 
Member States shall apply these provisions with effect from 
1 July 1998. 
Member States- shall communicate to the Commission the texts 
of the provisions of national law which they adopt in the 
field covered by this Directive. 
52> 
36 
Member States shall take the necessary action to ensure that 
the notified bodies which are responsible pursuant to Article 
9 for conformity assessment take account of any relevant 
information regarding the characteristics and performance of 
such devices, including in particular the results of any 
relevant tests and verification already carried out under 
pre-existing national law, regulations or administrative 
provisions in respect of such devices. 
Member States shall accept during a period of four years 
following adoption of the present Directive the placing on 
the market and putting into service of devices which conform 
to the rules in force in their territory on the date of 
adoption of this Directive. 
Article 21 
This Directive, shall enter into force the twentieth day after its 
publication. 
Article 22 
This Directive is addressed to the Member States. 
-37-
Annex 1 
ESSENTIAL REQUIREMENTS 
I. GENERAL REQUIREMENTS 
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, e-r- the 
safety and health of users and, where applicable, other 
persons, and 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 are compatible with a 
high level of protection of health and safety. 
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» 
J 
inform users of the residual risks due to any 
shortcomings of the protection measures. 
-38-
The devices must be designed and manufactured in such ~a~ way 
that they are suitable for the purposes referred to in 
Article l(2)(b), as specified by the manufacturer, taking 
account of the generally acknowledged state of the art. They 
must achieve the performances in particular in terms of 
analytical sensitivity, specificity, accuracy, repeatability, 
reproducibility and limits of detection stated by the 
manufacturer. 
The traceability of values assigned to calibrators and/or 
controls materials must be assured through available reference 
measurement procedures and/or available reference materials 
of higher order. 
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 indicated by the manufacturer, 
when the device is subject 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. 
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 in the 
storage and transport conditions (temperature, humidity, ...) 
taking account of the instruction and information provided by 
the manufacturer. 
-39-
II. REQUIREMENTS REGARDING DESIGN AND MANUFACTURING 
6. Chemical and physical properties 
6.1. The devices must be designed and manufactured in such a 
way as to achieve the characteristics and performances 
referred to in Section I on the "General Requirements". 
Attention must be paid to the possibility of impairment 
of analytical performance due to incompatibilityvbetween 
the materials used and the samples (such . as biological 
tissues, cells, body fluids and micro-organisms) 
intended to be used with the device, taking account of 
its intended purpose. 
6.2. The devices must be designed, manufactured and packed in 
such a way as to reduce as far as possible the risk 
posed by leakage products, 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. 
7. Infection and microbial contamination 
7.1. The devices must be designed in such a way as to 
eliminate or reduce as far as possible the risk of 
infection to the user or other persons. The design must 
allow easy handling and, where necessary, reduce as far 
as possible contamination 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. 
-40-
7.2. Where a device incorporates biological substances," "the 
risks of infection must be reduced as far as possible by 
selecting appropriate donors, appropriate substances and 
using appropriate ihactivation, conservation, test and 
control procedures. 
7.3. Devices labelled either as "STERILE", or, as h&Ying & 
special microbiological state must be designed, 
manufactured and packed in an appropriate pack, 
according to procedures suitable to ensure that they 
remain in the microbiological state indicated on the 
label when placed on the market, under the storage and 
transport conditions as laid down by the manufacturer, 
until the protective packaging is damaged or opened. 
7.4. Devices labelled either as "STERILE", or, as having a 
special microbiological state must have been' processed 
by an appropriate, validated method. 
7.5. Packaging systems for devices other than those referred 
to in section 7.3 must keep the product without 
deterioration at the level of cleanliness, if any, as 
indicated by the manufacturer and, if the devices are to 
be sterilized prior to use, reduce as far as possible 
the risk of microbial contamination. 
• Steps shall be taken to reduce microbial contamination 
during selection and handling of raw materials, 
manufacture, storage and distribution where the 
performance of the device can be adversely affected by 
such contamination. 
<y 
-41-
8. Construction and environmental properties 
8.1. 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. 
8.2 Devices must be designed and manufactured in such a way 
as to remove or reduce as far as possible : 
the risk of injury, in connection with their 
physical features, including aspects of 
volume x pressure, dimensional" and where appropriate 
ergonomie features; 
risks connected with reasonably foreseeable 
external influences, such as magnetic fields, 
external electrical effects, electrostatic 
discharge, pressure, temperature or variations in 
pressure or acceleration. 
Devices must be designed and manufactured in such a way 
as to provide an adequate level of intrinsic immunity 
from electromagnetic disturbance to enable them to 
operate in accordance with their intended purpose. 
^ 
-42-
Devices must be designed, and manufactured in such a way 
as to reduce as far as possible the risks of fire or 
explosion during normal use. Particular attention must 
•L 
be paid to devices whose intended use includes exposure 
to or use in association with flammable substances or 
substances which could cause combustion. 
4. Devices must be designed and manufactured in such a way 
as to facilitate the management of safe waste disposal. 
5 The measuring, monitoring or display scale (including 
colour change and other visual indicators) must be 
designed and manufactured in line with ergonomie 
principles, taking account of the intended purpose of 
the device. 
Devices which are instruments or apparatus with a measuring 
function 
9.1. Devices which are instruments or apparatus having a 
primary analytical 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. 
CC 
-43-
9.2. When values are expressed numerically, they must be 
given in legal units conforming to the provisions of 
Council Directive 80/181/EEC n 
10. Protection against radiation 
10.1 Devices shall be designed and manufactured in such a way 
that exposure of users and other persons to the emitted 
radiation is reduced as far as possible-. 
10.2 When devices are intended to emit potentially hazardous, 
visible and/or invisible radiation, they must be : 
- designed and manufactured in such a way as to ensure 
that the quality and quantity of radiation emitted can 
be adjusted and controlled; 
- fitted, where practicable, with visual displays and/or 
audible warnings of such emissions. 
10.3 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 eliminating 
the risks inherent in installation. 
OJ Nr. L 39. 15.02.1980, p. 40, directive as last amended by Directive 89/617/EEC, OJ Nr. L 357, 
07.12.1989. P. 28. 
(a\ 
-44-
11. Requirements for medical devices connected to or equipped 
with an energy source 
11.1 Devices incorporating electronic programmable systems 
must be designed to ensure the repeatability, reliability 
and performance of these systems according to the 
intended use. 
11.2 Devices must be designed and manufactured in such a way 
as to minimize the risks of creating electromagnetic 
fields which could impair the operation of other devices 
or equipment in the usual environment. 
11.3 Devices must be designed and manufactured in such a way 
as to. avoid, as far as possible, the risk of accidental 
electric shocks during normal use and in single fault 
condition, provided the devices are installed and 
maintained correctly. 
11.4 Protection against mechanical and thermal risks 
11.4.1 Devices must be designed and manufactured in such a way 
as to protect the user against mechanical risks 
connected with, for example, resistance, stability and 
moving parts. Annex 1, sections 1.3 and 1.4 of 
Directive 89/392/EEC 12 shall apply, were appropriate. 
12 Council Directive 89/392/EEC, OJ Nr. L 183, 29.6.1989, as last amended by Council Directive 
93/68/EEC, OJ Nr. L 220, 30.8.1993, p. I 
- 45 -
11.4.2 Devices must be designed and manufactured in such a way 
as to reduce to the lowest possible level the risks 
arising from vibration generated by the devices, taking 
account of technical progress and of the means 
available for limiting vibrations, particularly at 
source, unless, the vibrations are part of the specified 
performance. 
11.4.3 Devices must be designed and manufactured in such a way 
as to reduce to the lowest possible level the risks 
arising from the noise emitted, taking account of 
technical progress and of the means available to reduce 
noise, particularly at source, unless the noise emitted 
is part of the specified performance. 
11.4.4 Terminals and connectors to electricity, gas or 
hydraulic and pneumatic energy supplies which the user 
has to handle must be designed and manufactured in such 
a way .as .to minimize all possible risks. 
11.4.5 Accessible parts of the devices (excluding the parts or 
areas intended to supply heat or reach given 
temperatures) and their surroundings must not attain 
potentially dangerous temperatures under normal use. 
- 46 -
12. Requirements for devices for self-testing 
Devices for self-testing must be designed and manufactured in 
such a way that they perform appropriately for their intended 
purpose taking into account the skills and the means 
available to users and the influence 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. 
12.1 Devices for self-testing must be designed and 
manufactured in such a way as to reduce as far as 
practicable the risk of user's error in handling and in 
interpretation of the result. 
12.2 Devices for self-testing must, where reasonably 
possible, include a method of user control, i.e. a 
procedure by which the user can reasonably verify that, 
at the time of use, the product will perform as 
intended. 
13. Information supplied by the manufacturer 
13.1 Each device must be accompanied by the information 
needed to use . it properly, taking account of the 
training and knowledge of the potential users and to 
identify the manufacturer. 
-47-
This information comprises the data on the label and in 
the instructions for use. 
As far as practicable and appropriate, the information 
needed to use the,device properly must be set out on the 
device itself and/or on the packaging or, where 
appropriate, on the sales packaging. If individual full 
labelling of each unit is not practicable, the 
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. 
By way of exception, no such instructions for use are 
needed for a device if it can be used properly and safely 
without them. 
13.2 Where appropriate, this information to be supplied 
should take the form of symbols. Any symbol and 
identification colour used must conform to the 
harmonized standards. In areas for which no standards 
exist, the symbols and colours as used must be described 
in the documentation supplied with the device. 
L< 
-48-
13.3 In the case of devices containing a substance or being 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 
Directive 67/548/EEC and Directive 88/379/EEC shall 
apply. Where there is insufficient space to put all 
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 appropriante is already made available by 
the instructions for use. 
13.4 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, 
in view of their distribution in the Community, the 
label, or the outer packaging, or instructions for 
use, shall contain in addition the name and address of 
the authorized representative of the manufacturer 
established within the Community; 
G?C? 
-49-
b) the details strictly necessary for the user to 
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) where appropriate, the batch code, preceded by the 
word "LOT", or the serial number; . 
e) where appropriate, an indication of the date by which 
the device or part of it should be used,, expressed as 
the year, the month and, where relevant, the day; 
f) in cases of devices for performance evaluation, the 
words "for performance evaluation only"; 
g) where appropriate, a statement indicating the in vitro 
nature of the device; 
h) any special storage and/or handling conditions; 
i) where applicable any special operating instructions; 
j) appropriate warnings and/or precautions to take; 
k) if the device is intended for self-testing, this fact 
should be clearly stated. 
1) In the case of "devices incorporating tissues of human 
origin or substances derived from such tissues, a 
statement indicating that the device incorporates 
tissues or substances derived from tissue of human 
origin. 
13.5 If the intended purpose of the device is not obvious to 
the user, the manufacturer must clearly state the 
intended purpose in the instructions for use and, if 
appropriate,- on the label. 
-SO­
IS. 6 Wherever reasonable and practicable, the devices and 
detachable components must be identified, where 
appropriate in terms of batches, to allow all 
appropriate action to detect any potential risk posed by 
the devices and detachable components. 
13.7 Where appropriate, the instructions for use must contain 
the following particulars : 
a) the details referred to in Section. 13.4, with 
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 tas well as a statement that the 
device contains other ingredients influencing the 
measurement; 
c) the storage conditions and shelf life following the 
first opening of the immediate container, together 
with the storage conditions and stability of working 
reagents; 
d) the performances referred to in Section 3; 
e) a statement of any special materials required 
including information necessary to enable those 
special materials to be identified for proper use; 
f) the type of specimen to be used, any special 
conditions of collection, pre-treatment and, if 
necessary, storage conditions; 
g) a detailed description of the procedure to be followed 
in using the device; 
/ s/ 
D -51-
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. analytical sensitivity, specificity, 
accuracy, repeatability, reproducibility and limits 
of detection), 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 procedures, 
- the traceability of the calibration of the device; 
1) the reference intervals for the quantities being 
determined; 
-52-
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 properly installed and can operate correctly 
and safely, plus details of the nature and frequency 
of the maintenance and calibration needed to ensure 
that the device operates properly and safely; 
information about safe waste disposal; 
o) the necessary instructions in the event of damage to 
the sterile protective packaging and details of 
appropriate methods of resterilization or 
decontamination; 
p) if the device is reusable, information on the 
appropriate processes to allow reuse, including 
cleaning, disinfection, packaging and resterilization 
or decontamination, and any restriction on the number 
of reuses; 
q) precautions to be taken as regards exposure, in 
reasonably foreseeable environmental conditions, to 
magnetic fields, external influences, electrostatic 
discharge, pressure or variations in pressure, 
acceleration, thermal ignition sources, etc.; 
-53-
r) precautions to be taker! 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 shall be drawn to their potential infectious 
nature; 
s) specifications for devices for self-testing : 
- the results need to be expressed and presented in a 
way that is readily understood by a non­
professional • person; information needs to be 
provided with advice to the 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 know how 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; 
t) date of issue or last revision of the instructions for 
use. 
^v 
54-
Annex 2 
LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) 
1. Reagents and reagent products for blood grouping (ABO 
system and Rho/D) 
2. Reagents and reagent products for the detection in human 
specimens of markers of HIV infection, Hepatitis B and C . 
^2. 
55-
Annex 3 
EC DECLARATION OF CONFORMITY 
The EC declaration of conformity is the procedure whereby the 
manufacturer or his authorized representative established in 
the Community who fulfils the obligations imposed by Sections 
2 to 5 and additionally, 4in 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 with Article 14. 
2. The manufacturer must prepare the technical documentation 
described in Section 3 and ensure that the manufacturing 
process follows the principles 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 : 
-^ 
-56-
- a general description of the product, including any variants 
planned; 
- the documentation of the, quality system; 
- design information, including performance characteristics 
and limitation, methods of manufacture and, in the case of 
instruments, design drawings, diagrams of components, sub­
assemblies, circuits, etc.; 
- the descriptions and explanations necessary to understand 
the abovementioned characteristics, drawings .and diagrams 
and the operation of the product; 
- the results of the risk analysis, where appropriate, and a 
list of the standards referred to in Article 5, applied in 
full or in part, and descriptions of the solutions adopted 
to meet the essential requirements of the Directive if the 
standards referred to in Article 5 have not been applied in 
full; 
- in the case of sterile products or products with a special 
microbiological state or state of cleanliness, a description 
of the procedures used; 
- the result's 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,* 
-57-
- adequate performance evaluation data, supported by a 
reference measurement system (when available), originated 
from studies in a clinical or other appropriate environment 
or resulting from available literature; this applies in 
particular to biological materials, culture media and 
devices using a new technology; 
- the labels and instructions for use. 
The manufacturer shall take necessary measures to ensure^ that 
the manufacturing process follows the principles of quality 
assurance as appropriate for the products manufactured. 
The system shall address : 
the organizational structure and responsibilities, 
the manufacturing processes and systematic quality control 
of production; 
the means to monitor the performance of the quality system; 
"6 
-58-
The manufacturer shall 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 actions, taking 
account of the nature and risks in relation to the product. 
He shall notify the' competent authorities of the following 
incidents immediately on learning of them : 
(i) any malfunction, 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 to a 
serious deterioration in his state of health; 
(ii) any technical or medical reason connected with the 
characteristics or the performance of a device for the 
reasons referred to in subparagraph (i) above leading to 
systematic recall ,of devices 'of the 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. 
\, 
-59 
It shall include : 
test reports including, where appropriate, results of 
studies carried out with lay 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 devi-ce 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 applicant with an EC design-
examination certificate. The 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 examination, the conditions 
of validity, the data needed7 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 designed-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 
certificate 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 supplement to 
the EC design-examination certificate. 
60-
Annex 4 
EC DECLARATION OF CONFORMITY 
(FULL QUALITY ASSURANCE SYSTEM) 
1. The manufacturer must ensure application of the quality 
system approved for the design, manufacture and final 
inspection of the products concerned, as specified in Section 
3, and is subject to audit as laid down in section 3.3 and to 
the EC surveillance as specified in Section 4. 
2. The declaration of conformity is the procedure whereby the 
manufacturer who fulfils the obligations imposed by Section 1 
ensures and declares that the products concerned meet the 
provisions of,this Directive which apply to them. 
The manufacturer shall affix the CE marking in accordance 
with Article 14 and shall draw up a declaration of conformity 
covering the products concerned. 
3. Quality system 
3.1 The manufacturer must lodge an application for assessment 
of his quality system with a notified body. 
% 
61 -
The application must include: 
- the name and address of the manufacturer and any 
additional manufacturing site covered by the quality 
system; 
- adequate information on the product or product category 
covered by the procedure; 
- a written declaration that no such application has been 
* lodged with any other notified body for the same 
product-related quality system; 
- the documentation on the quality system; 
- an undertaking by the manufacturer to fulfil the 
obligations imposed by the quality system approved; 
- an undertaking by the manufacturer to keep the approved 
quality system adequate and efficacious; 
- an undertaking by the manufacturer to institute and 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 3, section 5 . 
3.2 Application of the quality system must ensure that the 
products conform to the provisions of this Directive which 
apply to them at every stage, from design to final 
inspection. All the elements, requirements and provisions 
adopted by the manufacturer for his quality system must be 
documented in a systematic and orderly manner in the form 
of written policies and procedures, such as quality 
programmes, quality plans, quality manuals and quality 
records. 
- 62 -
It shall include in particular an adequate description of: 
(a) the manufacturer's quality objectives; 
(b) the organization of the business and in particular: 
- the organizational structures, the responsibilities 
of the managerial staff and their organizational 
authority where quality of design and manufacture 
of the products is concerned; 
- the methods of monitoring the efficient operation 
of the quality system and in particular its ability 
to achieve the desired quality of design and of 
product, including control of products which fail 
to conform; 
(c) the procedures for monitoring and verifying the design 
of the products and in particular: 
- a general description of the product, including any 
variants planned; 
- all documentation referred to in Annex 3, section 
3, indents 3 to 11; 
- in the case of devices for self-testing, the 
information referred to in Annex 3, section 6.1; 
- the techniques used to control and verify the 
design and the processes and systematic measures 
which will be used when the products are being 
designed; 
(d) the inspection and quality assurance techniques at the 
manufacturing stage and in particular: 
- the processes and procedures which will be used, 
particularly as regards sterilization and 
purchasing; 
*> 
-63-
- the product identification procedures drawn up and 
kept up to date from drawings, specifications or 
other relevant documents at every stage of 
manufacture; 
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 of the test equipment adequately. 
3.3 The notified body must audit the quality system to 
determine whether it meets the requirements referred to 
in Section 3.2. It must presume that quality systems 
which implement the relevant harmonized standards 
conform to these requirements. 
The assessment team must include at least one member with 
past experience of assessments of the technology 
concerned. The assessment procedure must include an 
inspection on the manufacturer's premises and, in duly 
substantiated cases, on the premises of the 
manufacturer's suppliers and/or subcontractors to inspect 
the manufacturing processes. 
The decision 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. 
-64-
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 
4.1 The aim of surveillance is to ensure that the 
manufacturer duly fulfils the obligations imposed by the 
approved quality system. 
t-
4.2 The 'manufacturer must authorize the notified body to 
carry out all the necessary inspections and supply it 
with all relevant information, in particular: 
- the documentation on the quality system; 
- the data stipulated in the part of the quality system 
relating to design, such as the results of analyses, 
calculation, tests, etc.; 
- the data stipulated in the part of the quality system 
relating to manufacture, such as inspection reports and 
test data, calibration data, qualification reports of 
the personnel concerned, etc. 
4.3 The notified body must periodically carry out appropriate 
inspections and assessments to make sure that the 
manufacturer applies the approved quality system and must 
supply the manufacturer with an assessment report. 
<X7 
-65-
4.4 In addition, the notified body may pay unannounced visits 
to the manufacturer. 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. 
-66-
Annex 5 
EC TYPE-EXAMINATION 
1. EC type-examination is the part of the procedure whereby a 
notified body ascertains and certifies that a representative 
sample of the production envisaged fulfils the relevant 
provisions of this Directive. 
2. The application for EC type-examination shall be lodged by the 
manufacturer or by his authorized representative established 
in the Community with a notified body. 
The application shall include: 
the name and address of the manufacturer and the name and 
address of the authorized representative if the application 
is lodged by the representative; 
the documentation described in Section 3 needed to assess 
the conformity 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. 
-67-
3. The documentation must allow an understanding of the design, 
the manufacture and the performances of the product. The 
documentation " shall contain the following items in 
particular: 
- a general description of the type, including any variants 
planned; 
- all documentation referred to in Annex 3, section 3, indents 
3 to 5, 7, 10 and 11, 
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 
abovemehtioned standards; 
4.2 perform or have performed appropriate examinations and the 
tests necessary 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; 
-68-
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 applicant shall inform the notified body which issued the 
EC type-examination certificate of any significant change made 
to the approved product. 
Changes to the approved product must receive further approval 
from the notified body which issued the EC type-examination 
certificate wherever the changes may affect conformity with 
the essential requirements or with the conditions prescribed 
for use of the product. This new approval shall, where 
appropriate, take the form of a supplement to the initial EC 
type-examination certificate. 
-69-
7. Administrative provisions . 
Other notified bodies may obtain a copy of the EC type-
examination certificates and/or the supplements thereto. The 
annexes to the certificates must be made available to the 
other notified bodies on reasoned application, after the 
manufacturer has been informed. 
-70-
Annex 6 
EC VERIFICATION 
EC verification is the procedure whereby the manufacturer or 
his authorized représentative established in the Community 
ensures and declares that the products which have ' been 
subject to the procedure set out in Section 4 conform to the 
type described in the EC type-examination certificate and meet 
the requirements of this Directive which apply to them. 
2.1 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 to the requirements of the Directive which 
apply, to them.' Before;, the start of manufacture, the 
manufacturer ' . must prepare documents defining the 
manufacturing process, in particular as regards sterilization 
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 provisions 
must be implemented to ensure homogeneous production and 
conformity of the products with the type described in the EC 
type-examination certificate and with the requirements of this 
Directive which apply to them. The manufacturer must affix 
the CE marking in accordance with Article 14 and draw up a 
declaration of conformity covering the products concerned. 
-71-
2.2 To the extent that for certain aspects the final testing 
according to section 6.3 is not appropriate, adequate in 
process testing, monitoring and control methods shall be 
established by the manufacturer with the approval of the 
notified body. The provisions of Annex 4 section 4 shall 
apply accordingly in relation to the above mentioned 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 3 section 5. 
The notified body must carry out the appropriate examinations 
and tests in order to verify the conformity of the product 
with the requirements of the Directive either by examining 
and testing every product as specified in section 5 or by 
examining and testing products on . a statistical basis as 
specified in section 6, as the manufacturer decides. 
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 with section 2.2 ensures an equivalent level of 
conformity. 
-72-
5. Verification by examination and testing of every product 
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 each approved product and must 
draw up a written certificate of conformity relating to 
the tests carried out. 
6. Statistical verification 
6.1 The manufacturer must present the manufactured products in 
the form of homogeneous batches. 
6.2 A random sample is taken from each batch. The products 
which make up the sample are examined individually and the 
appropriate tests defined in the relevant standard(s) 
referred to in Article 5 " or equivalent tests must be 
carried out to verify, where appropriate, the conformity 
of the products with the type described in the EC type-
examination certificate and with the requirements of the 
Directive which apply to them in order to determine 
whether to accept or reject the batch. 
- 73 -
3 Statistical control of products will be based on 
attributes, entailing a sampling system ensuring a limit 
quality corresponding to a probability of acceptance of 
5%, with a non-conformity percentage of between 3 and 7%. 
The sampling method will be established by the harmonized 
standards referred to in Article 5, taking account of the 
specific nature of the product categories in question. 
6.4 If the batch is accepted, the notified body affixes, or 
has affixed its identification number to each product and 
draws up a written certificate of conformity relating to 
the tests carried out. All products in the batch may be 
put on the market except any in the sample which failed to 
conform. 
If a batch is rejected the competent notified body must 
take appropriate measures to prevent the batch from being 
placed on the market. In the event of frequent rejection 
of batches, the notified body may suspend the statistical 
verification. 
The manufacturer may, on the responsibility of the 
notified body, affix the notified body's identification 
number during the manufacturing process. 
a i 
74-
Annex 7 
EC DECLARATION OF CONFORMITY 
(PRODUCTION QUALITY ASSURANCE) 
1. The manufacturer must ensure application of the quality 
system approved for the manufacture of the products concerned 
and carry out the final inspection, as specified in Section 
3, and is subject to the EC surveillance referred to in 
Section 4. 
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 14 and draw up a declaration of conformity. 
-75-
3. Quality system 
3.1 The manufacturer must lodge an application for'assessment 
of his quality system with a notified body. 
The application must include: 
-, all documentation and undertakings referred to' in Annex 
.. 4 section 3.1 and 
- 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 
products conform to the type described in the EC type-
examination certificate. 
All the elements, requirements and provisions- adopted by the 
manufacturer for his quality system must be documented in a 
systematic and orderly manner in the form of written policy 
statements and procedures. This quality system documentation 
must permit uniform interpretation of the quality policy and 
procedures such as quality programmes, plans, manuals and 
records. 
It must include in particular an adequate description of: 
the manufacturer's quality objectives; 
-76-
(b) the organization of the business and in particular 
the organizational structures, the responsibilities of 
the managerial staff and their organizational 
authority where manufacture of the products is 
concerned; 
the methods of monitoring the efficient operation' of 
vthe quality, system and in particular its ability to 
achieve the desired quality of product, including 
control of products which fail to conform; 
c) the inspection and quality assurance techniques at the 
manufacturing stage and in particular: 
- the processes and procedures which will be used, 
particularly as regards sterilization and 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 adequately to trace back the calibration 
of the test equipment. 
-77-
3.3 The notified body must audit the quality system to 
determine whether it meets the requirements referred to in 
Section 3.2. It must presume that quality systems which 
implement the relevant harmonized standards conform to 
these requirements. 
The assessment team must include at least one member with 
past experience of assessments of the technology 
concerned. The assessment procedure must include an 
inspection on the manufacturer's premises and, in duly 
substantiated cases, on the premises of the manufacturer's 
suppliers and/or subcontractors to inspect the 
manufacturing processes. 
The decision must be notified to the manufacturer after 
the final inspection and contain the conclusions of the 
inspection and a reasoned assessment. 
3.4 The manufacturer 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. 
Surveillance 
The provision of Annex 4, section 4, shall apply 
"15 
-78-
Annex 8 
STATEMENT AND PROCEDURES CONCERNING DEVICES 
FOR PERFORMANCE EVALUATION 
1. For devices for performance evaluation the manufacturer or 
his authorized representative established in the Community 
shall draw up the statement containing the information 
stipulated in Section 2 of this Annex and ensure that the 
relevant provisions of this Directive are met. 
2. The statement shall contain the following information: 
the list of laboratories or other institutions taking part 
in the performance evaluation study; 
in the case of devices for self-testing, the place, 
starting date and scheduled duration for the investigations 
and the 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 investigation and apart from those 
specifically itemised in the statement, and that every 
precaution has been taken to protect the health and safety 
of the patient, user and third parties. 
-79-
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 with the 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 documentation mentioned in the 
first paragraph. 
HI 
-80-
Annex 9 
CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES 
The notified body, its Director and the assessment and 
verification staff shall not be the designer, .manufacturer, 
supplier, installer or user of the devices which they 
inspect, nor the authorized representative of any of these 
persons. They may not be directly involved in the design, 
construction, marketing or maintenance of the devices, nor 
represent the parties engaged in these activities. This in no 
way precludes the possibility of exchanges of technical 
information between the manufacturer and the body. 
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 pressures 
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 establishment 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 assessing 
the subcontractor's qualifications and the work carried out 
by the subcontractor under this Directive. 
<\<k 
-81-
3. The notified body must be able to carry out all the tasks 
assigned to such bodies by one of Annexes 3 to 7 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. 
It must also have access to the equipment necessary for the 
verifications required. 
4. The notified body must have: 
sound vocational training covering all the assessment and 
verification operations for which the body has been 
designated; 
satisfactory knowledge of the rules on the inspections 
which they carry out and adequate experience of such 
inspections; 
the ability required to draw 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 remuneration must not depend on the number of 
inspections carried out, nor on the results of the 
inspections. 
-82-
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. 
83-
Annex 10 
CE MARKING OF CONFORMITY 
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. 
ANNEX 
DRAFT 
DECISION OF THE EEA JOINT COMMITTEE 
No. [ ,..] 
amending Annex II, Technical regulations, standards, 
testing and certification, to the Agreement on the 
European Economic Area 
THE EEA JOINT COMMITTEE, 
Having regard to the Agreement on the European Economic Area, as adjusted by the Protocol 
Adjusting the Agreement on the European Economic Area, hereinafter referred to as the 
Agreement, and in particular Article 98 thereof; 
Whereas Directive ....../ /EEC of..../ / (OJNo. L ...) on in vitro diagnostic 
medical devices is to be integrated into the Agreement, 
HAS DECIDED AS FOLLOWS : 
Article 1 
The following shall be inserted in Annex II to the Agreement : 
Directive / /EC on in vitro diagnostic 
medical devices 
Article 2 
The texts of Directive ..../...../.EC in the Finnish, Icelandic, Norwegian and Swedish languages, 
which are annexed to the respective language versions of this decision, are authentic 
Article 3 
This Decision shall enter into force on [ ] [ ], provided that all the notifications under 
Article 103(1) of the Agreement have been made to the EEA Joint Committee 
-2-
Article 4 
This decision shall be published in the EEA Section of, and in the EEA Supplement to, the 
Official Journal of the European Communities 
For the EEA Joint Committee 
The President 
The Secretaries 
to the EEA Joint Committee 
ANNEX 
FINANCIAL STATEMENT 
Financial implications (details for publication in the working papers) 
1. TITLE OF OPERATION 
Proposal for a Directive on in vitro diagnostic medical devices 
2. BUDGET HEADING 
B5-300 Measures concerning the internal market; Operating appropriations 
B5-7210 Development of a data interchange system 
3. LEGAL BASIS 
Article 100a,of the EC Treaty. 
4. DESCRIPTION OF OPERATION 
4.1 Specific objectives of operation: Jhe^specific objective of this operation is to 
establish the internal market in in-vitro diagnostic medical devices. 
This proposal is intended to complement the existing Directives 90/385/EEC (on 
active implantable medical devices) and 93/42/EEC (on medical devices) by 
introducing Community legislation governing the placing on the market of in vitro 
diagnostic medical devices. The Directive aims at ensuring the safety and 
protecting the health of patients, users of the devices concerned and third parties. 
Harmonized rules will ensure free movement of the devices and prevent the 
emergence of new barriers to trade. 
2-
Following the principles laid down in the new approach, the Directive provides for 
harmonization of the essential safety requirements and for the conformity 
assessment procedures which in vitro diagnostic medical devices must satisfy when 
they are placed on the market. Effective implementation of this Directive will 
entail: 
drafting of harmonized standards by the CEN/CENELEC; if these are 
applied, conformity with the- essential requirements in the Directive will be 
presumed; 
establishment by the parties concerned and submission by the Commission 
of the guidelines necessary to ensure uniform application of the Directive, 
on its scope, the principles to be applied, the means to be employed to 
meet the essential requirements, etc.; 
concertation between the notified bodies on the certification procedures; 
exchanges of information between the Member States concerning 
application and monitoring of the Directive; 
management by the Commission of the procedures for implementing the 
safeguard clauses, which will imply seeking the opinion of high-level 
experts. 
4.2 Duration: Ad hoc measure. 
4.3 Target population: Every citizen in the Community is a potential user of the 
devices covered by the Directive, since the products are employed in the health 
care sector. 
-3-
5. CLASSIFICATION OF EXPENDITURE 
5.1 Non-compulsory expenditure. 
5.2 Differentiated appropriations. 
5.3 No revenue is expected. 
6. TYPE OF EXPENDITURE 
The expenditure will be on: 
(a) standardization: The proposal for a Directive lays down the essential 
requirements. Article 5 refers to harmonized standards. As with the other 
new approach Directives, the Commission plans to give the 
CEN/CENELEC a mandate to draft the relevant harmonized standards. 
This mandate will cover technical formulation of the essential requirements 
defined in the proposal. It will be governed by the framework contract of 
15 September 1992, which provides for financial support from the 
Commission. 
(b) development of a data interchange system: The registration procedures for 
manufacturers (Article 10) and the vigilance system (Article 11) involve 
exchanges of official data between the Member States, the parties 
concerned and the Commission. The development of a system facilitating 
data interchange will therefore be essential if the directive is to be fully 
effective. To this end, the profiles of the data to be exchanged must be 
established, procedures must be devised and common software must be 
provided. 
4-
6.1 100% subsidy: none. 
6.2 Subsidy for joint financing with other sources in the public and/or private sector: 
none. 
6.3 Interest subsidy: none. 
6.4 Other: none. 
6.5 Should the operation prove an economic success, is there provision for all or part 
of the Community contribution to be reimbursed? No. 
6.6 Will the proposed operation cause any change in the level of revenue? No. 
-5-
7. FINANCIAL IMPACT 
7.1 Method of calculating total cosî of operation 
7.1.1 Standardization 
(a) Estimated cost of: 
- drafting the standards: In the order of 25 harmonized standards will have 
to be drafted. 
The funding will depend on the work given to the contractors. 
On average, the estimated financial contribution from the Commission for 
drafting a standard is a flat rate of ECU 50 000. Total expenditure of 
ECU 1.25 million is expected. 
- developing a data interchange system between the Member States. 
The cost of a project such as referred to in point 6b, to be carried out in 
1996/1997, is estimated at ECU 300 000. 
-6-
(b) The indicative schedule of appropriations could be as follows 
Commitment appropriations 
(1.000 ECU 
1995 750 
1996 650 
1997 150 
1998 
1999 
1550 Payment appropriations 
(1.000 ECU) 
350 
500 
300 
300 
100 
1550 
7.2 Itemized breakdown of cost 
ECU 
BREAKDOWN 
Standardization (B5-300) 
* Mandate 1994 
BUDGET 
-1995 
PRELIMINARY 
DRAFT BUDGET 
750 000 PERCENTAGE 
CHANGE 
-
7.3 Indicative schedule of commitment appropriations 
ECU 
Standardization 
(B5-300) 
Mandate 
Development of a 
data interchange 
system between the 
Member States 
(B5-7210) 1994 
BUDGET 1995 
PRELIMINARY 
DRAFT BUDGET 
750 000 INDICATIVE SCHEDULE 
1996 
500 000 
150 000 1997 
150 000 1998 1999 2000 
l< 
8. FRAUD PREVENTION MEASURES 
The Commission verifies the subsidies or receipt of the services and preparatory, 
feasibility or evaluation studies ordered before payment, taking account of the 
contractual obligations and of the principles of economy and sound financial or 
general management. All agreements or contracts concluded between the 
Commission and recipients of payments include fraud prevention clauses (on 
monitoring, submission of reports, etc.). 
9. ELEMENTS OF COST-EFFECTIVENESS ANALYSIS 
9.1 Objectives 
This new approach Directive is a measure to complete the internal market. The 
reference to harmonized standards is part of the Commission's multiannual 
programme to support reinforcement and extension of European standardization. 
9.2 Grounds for the operation 
The. national legislation on in vitro .diagnostic medical devices is extremely 
heterogeneous and takes different approaches to safety which make application of 
the principle of mutual recognition delicate. 
t\o 
The diverging requirements imposed by the national systems, both on the products 
and on the procedures for placing them on the market, give rise to enormous 
wastage of human and financial resources at the expense of the manufacturers and 
of the Member States. 
The Community procedures will avoid multiple repetition with the same objective. 
In addition, the harmonized requirements will allow industry to make savings on 
unit production costs. 
The harmonization of standards is designed to pool resources and thereby avoid 
duplication of expenditure by the Member States. 
All in all, the resources required from the Community budget are only a small 
proportion of the total resources which the Member States and parties concerned 
will release for the common good as a result of the operation. 
9.3 Monitoring and evaluation of the operation 
9.3.1 Performance indicators selected 
degree of harmonization of standards (number of standards); 
number of certifications carried out; 
number of reports of undesirable incidents; 
number of infringement procedures. 
\\\ 
9-
9.3.2 Details and frequency of planned evaluation: 
regular progress reports on standardization under Council 
Directive 83/189/EEC, at least once a year. 
9.4 Coherence -with financial programming 
9.4.1 The operation is included in DG Ill's financial programming. 
9.4.2 Broader objectives defined in DG Ill's financial programming: not applicable. 
9.4.3 Main factors of uncertainty which could affect the specific results of the operation: 
not applicable. 
10. ADMINISTRATIVE EXPENDITURE (PART A OF THE BUDGET) 
10.1 The proposed operation will involve an increase in the number of Commission 
staff for administration of the Directive. 
The procedures concerning the safeguard clauses, monitoring of European 
standardization and administrative cooperation presuppose the availability of staff 
capable of administration and evaluation of analyses and technical or legal 
opinions. 
The staff requirements will be covered either by internal redeployment or by a 
Commission decision allocating resources in the budgetary procedure. It is 
estimated that Unit III.D.2 will require one grade A official from 1995 on. 
10-
FINANCIAL STATEMENT 
Financial implications (details for internal information) 
10.2 Amount of staff and operating expenditure generated by the proposed operation 
subject to the outcome of the budgetary procedure and the decision allocating 
resources 
10.2.1 Expenditure on staff covered by the Staff Regulations 
Titles Al and A2 : ECU 90 000 per year 
This item should be covered either through redeployment or under the 
allocation of resources decided each year by the Commission. 
10.2.2 Other expenditure from Part A of the budget: 
Budget items concerned and type of expenditure 
(a) A2500: Meetings of experts: To promote uniform application of 
the Directive, the Commission plans regular meetings with 
the experts from the Member States, representatives of the 
notified bodies and the European federations to coordinate 
their activities and harmonize their practices. 
Estimated annual cost (from 1996 on): 
24 experts x 3 meetings per year x ECU 658 per expert per 
meeting = ECU 47.376 per year. 
11 
(b) A1178 Technical assistance 
Consultants: In the pre-impiementation phase 
(1996-1997) consultants' fees are estimated to total 
ECU 25 000 per year. 
(c) A 2600" Studies 
Technical opinions: The technical opinions 
required to administer the safeguard clause 
procedures will be funded by study contracts. 
ECU 40 000 per year must be earmarked for this 
purpose from 1998 on. 
10.3 Itemized breakdown of cost (Part A of the budget) 
ECU 
BREAKDOWN 
(a) Al, A2 
(b) A2550: meetings 
Member States 
(c) All 78 /technical 
assistance (safeguard 
clauses) 1994 BUDGET 
-. 1995 
PRELIMINARY 
DRAFT BUDGET 
90.000 
25.000 PERCENTAGE 
CHANGE 
-
or Al 178 according to nomenclature for 1995. 
or Al 178 according to nomenclature for 1995. 
- 12 
10.4 Indicative schedule of appropriations 
ECU 
(a)Al,A2 
(b) Meetings with the 
Member States (A2500) 
(c) Studies and 
consultations 
* Consultants (Al 178) 
* Technical opinions 
(A2600) 
TOTAL 1994 
BUDGET 
-
-1995 
90.000 
25 000 
115.000 INDICATIVE SCHEDULE 
1996 
90.000 
47 376 
25 000 
162.376 1997 
90.000 
47 376 
25 000 
162.376 1998 
90.000 
47 376 
40 000 
177.376 1999 
90.000 
47 376 
40 000 
177.376 2000 
90.000 
47 376 
40 000 
177.376 
IMPACT ASSESSMENT FORM 
TITLE OF PROPOSAL: 
Proposal for a Directive of the European Parliament and the Council on in vitro 
diagnostic medical devices. 
REFERENCE NUMBER: 2111.2.1.1 
THE PROPOSAL 
This proposal is for a new approach Directive based on Article 100a of the 
Treaty. It is intended to achieve the following objectives: 
to complete the harmonization started by Directive 90/385/EEC on active 
implantable medical devices and Directive 93/42/EEC on medical devices 
for the products concerned; 
to ensure free movement of in vitro diagnostic medical devices by 
harmonizing the national legislation to protect the health and safety of 
patients and users; 
to remove the existing barriers created by the diverging regulations and 
prevent the emergence of new barriers. This proposal is essential to 
prevent the national legislation implementing the abovementioned 
Directives from deepening the differences; 
to create a favourable environment with uniform conditions of competition 
to enable the industry to benefit from the scale of the European Economic 
Area and to help make European industry more competitive. 
-2-
2. THE IMPACT ON BUSINESS 
(a) Nature of the businesses concerned 
The in vitro diagnostic device industry is highly developed in the 
Community and the EFTA countries. Estimates put world production in 
1992 at ECU 12.2 billion, of which 39% was from the USA, 38% from, 
Western Europe and 12% from Japan. 
Most of the 350 to 400 European undertakings in this sector are small or 
medium-sized businesses. Research activities are intense and account for an 
estimated 15 to 20% of the jobs in this industry. 
(b) Geographical distribution of the industry and market 
In Europe the leading manufacturers of in vitro diagnostic medical devices 
are Germany, Switzerland, France, Sweden, the Netherlands, the United 
Kingdom, Italy and Belgium. In 1992 the total market of ECU 4.6 billion 
broke down as follows: Germany 25 % ; Italy 23 % ; France 18 % ; Spain 
12%; United Kingdom 4%; Belgium 3.5%; Switzerland 3%; Austria 
3 % ; Netherlands 2 % ; Sweden 2 % ; Finland 1 % ; Denmark 1 % ; Norway 
1%; Ireland 0.5% (source: European Diagnostic Manufacturers 
Association, EDMA). 
(c) Are these businesses in regions eligible for regional aid in the Member 
States and under the ERDF? 
No particular concentration in these regions is known. 
u> 
WHAT WILL BUSINESS HAVE TO DO TO COMPLY WITH THE 
PROPOSAL? 
The proposal lays down the essential requirements which devices placed on the 
market must meet in order to protect the health and safety of patients, users and 
third parties. These requirements will be given firmer shape by harmonized 
standards which will be drafted by the European standardization organizations 
CEN/CENELEC and will remain voluntary. 
Before, placing their devices on the market, manufacturers must ensure that they 
comply with the regulations. The conformity assessments for an extremely large 
proportion of the devices will be conducted solely on the manufacturers' 
responsibility, without the intervention of any third party. 
The Directive will require manufacturers to apply the appropriate quality 
assurance principles for the devices manufactured. 
However, in thé case of devices particularly sensitive for health protection 
purposes, particularly AIDS and hepatitis tests, third party certification of the 
design and manufacture of the devices is required. 
For monitoring purposes, manufacturers must notify one of the competent 
authorities in the Community of their marketing activities and of any 
undesirable incidents. 
4. WHAT ECONOMIC EFFECTS IS THE PROPOSAL LIKELY TO HAVE? 
(a) On employment 
The proposal will have no particular impact on employment. However, the 
requisite adaptation to the new rules will help to safeguard existing jobs 
and, in certain cases, to create new ones. 
4-
(b) On investment and the creation of new businesses 
The proposal will have no direct impact on business start-ups or investment. 
Conditions on the single market to be created could have consequences for 
distribution of the devices. It will be possible to organize distribution 
according to the needs of the European market without having to maintain 
separate distribution systems in each Member State. 
(c) On the competitive position of businesses 
Initially, adaptation to the new requirements and implementation of the 
quality principles, where still necessary, will give rise to extra costs. The 
three-year transition period following adoption of the Directive will make it 
possible to spread these costs over this entire period. 
Once the adjustments have been completed, businesses will be able to 
benefit from the greater rationalization. Harmonization of the diverging 
regulatory systems will cut the costs caused by the current divergency. The 
European dimension of the market in turn will allow economies of scale. 
Businesses will face tougher competition from both inside and outside the 
Community. The abovementioned effects of the proposal will make 
European businesses more competitive at international level. 
Once the Community legislation is adopted the Community will be able to 
use it in its international negotiations to improve access for the European 
industry to markets in third countries. 
U1 
-5-
(d) On public health 
By ensuring that the devices placed on the market are reliable, the Directive 
will provide greater protection for public health. In particular, the 
performance and reliability of in vitro diagnostic devices will make it easier 
to take medical decisions at an early stage of treatment and yield savings in 
health care costs. 
5. DOES THE PROPOSAL CONTAIN MEASURES TO TAKE ACCOUNT OF 
THE SPECIFIC SITUATION OF SMALL AND MEDIUM-SIZED FIRMS? 
The proposal contains no specific measures applicable solely to small firms. 
The Directive is limited to the essential protection requirements, which will be 
laid down in voluntary harmonized standards, and will therefore provide a legal 
framework which can be applied flexibly. The introduction of harmonized 
standards will make it easier to comply with the Directive, particularly for small 
firms. The manufacturer's declaration proposed for a very large proportion of 
the devices will limit the costs generated by the regulations and thus take 
particular account of the interests of small businesses. 
The Commission will continue to ensure close involvement by the European 
federations representing the vast majority of small firms in this industry when 
implementing the proposed Directive. 
6. CONSULTATION AND OPINION OF THE TWO SIDES OF INDUSTRY 
Since 1991 the Commission has consulted the industrial and trade federations 
concerned with the aid of various working papers. Four meetings were held to 
examine a working paper at various stages. In addition, in 1992 and 1993 the 
EDMA, assisted by the Commission, organized two workshops specially on the 
proposal. Many bilateral meetings have been held with the parties concerned 
and talks on the subject have been given at numerous conferences. 
-6-
The following federations and organizations have been consulted: 
(a) Manufacturers 
EDMA (European Diagnostic Manufacturers Association) 
EUROM (European Federation of Precision, Mechanical and Optical 
Industries) 
ELPA (European Laboratory Plastics Association) 
(b) Users 
1FCC (International Federation of Clinical Chemistry) 
ECCLS (European Council for Clinical and Laboratory Standards) 
ICSH (International Council for Standardization in Haematology) 
ESCMID (European Society for Clinical Microbiology and Infectious 
Diseases) 
WASP (World Association of Societies of Pathology - European section). 
The parties concerned have recognized the need for harmonization with the aid 
of a Directive and support the principles established in this proposal. 
The EDMA, which represents more than 300 small firms, and the other 
industrial federations mentioned above have stressed the need to uphold the 
principle that the conformity assessment for a large proportion of the devices 
can be conducted on the manufacturers' responsibility. Under these 
circumstances, the introduction of the vigilance procedures combined with 
notification of new devices are recognized as adequate monitoring 
arrangements. Consequently, in the industry's view, any moves to extend third 
party certification could upset the balance of the monitoring measures proposed. 
ISSN 0254-1475 
COM(95) 130 final 
DOCUMENTS 
EN 06 15 
Catalogue number : CB-CO-95-140-EN-C 
ISBN 92-77-87648-4 
Office for Official Publications of the European Communities 
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