COMMISSION OF THE EUROPEAN COMMUNITIES 
C0MC91) 287 final - SYN 353 
Brussels, 23 August 1991 
Proposal for a 
COUNCIL DIRECTIVE 
concerning medical devices 
(presented by the Commission) 

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EXPLANATORY MEMORANDUM 
I. GENERAL FRAMEWORK 
This proposal for a directive has been prepared in the 
context of the White Paper on completing the internal 
market, the work programme of which provides for 
harmonization of the laws relating to electro-medical 
equ i pment . 
In this context, the Council adopted a first directive 
relating to active implantable medical devices 
(Directive 90/385/EEC) on 20 June 1990. With the adoption 
of this directive, a preponderant part of the field of 
medical devices will be covered by harmonized laws. 
However, medical devices intended for in vitro diagnosis are 
not included in the scope of this proposal. These products 
will be dealt with, in view of their particular nature, in a 
spec ific diective. 
Before starting on the preparation of its proposal, the 
Commission examined the regulations relating to the medical 
devices sector. The results of this examination confirmed 
that there are considerable differences between the Member 
States as regards both the technical design and production 
requirements and the administrative procedures for the 
examination, testing, inspection and authorization for 
marketing, and the putting into service and after-sales 
surveillance of medical devices. 
The current legislative situation in the Member States is 
characterized by a marked lack of uniformity if the various 
national laws are compared with regard to their scope and 
the kind of risks covered. A large number of specific laws 
cover certain groups of products such as electro-medical 
equipment, disposable products, equipment for the disabled, 
sterile products, and even specific products. In several 
Member States, a range of medical devices (in particular in 
the field of sterile and disposable products) are covered, 
in the absence of specific laws, by the regulations on 
medicinal products. The fact that medical equipment, which 
as a general rule acts physically, is sometimes treated the 
same as medicinal products, which act pharmacologically, has 
led in several cases to technical barriers. 
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With the regard to the means of .control used to ensure the 
safety and health protection of patients and users, two 
different approaches were found in the Community. A large 
number of the Member States apply systems based on the 
inspection of products before they are placed on the market 
by means of type-examinations or approval systems, while 
others ask companies to apply good manufacturing practices. 
Where the devices are subject to the rules on medicinal 
products, both product certification and authorization 
procedures for companies apply. 
The information obtained pursuant to Directive 83/189/EEC 
laying down an information procedure in the field of 
technical regulations confirms the lack of uniformity in the 
legislative approach taken with regard to medical devices. 
Between 1988 and 1990, some 25 sets of draft national 
regulations, most of them relating to specific products, 
were notified to the Commission. 
Lastly, it should be said that some of the Member States are 
aware of the unsatisfactory situation and have indicated 
their desire to establish an overall legal framework for the 
medical devices field. 
In view of the differences in approach, which by their 
nature are incompatible with a single Community market in 
medical devices, it is essential to set up a Community 
system of laws based on Article 100a of the EEC Treaty to 
abolish and prevent technical barriers to trade. 
The aim of this directive, therefore, is to ensure the 
safety and health protection of patients and users by means 
of a uniform sectoral approach and to create an appropriate, 
suitable framework for the technological development of the 
products concerned. 
The medical devices sector is a large market: world 
consumption of these products in 1990 has been put at 
ECU 54.1 billion, including ECU 23.1 billion in the USA a(1 
ECU - 1.2 US$) and ECU 15.0 billion in the Community 
(source: Health Industry Manufacturers Association (HIMA)). 
The Community share of world production has been calculated 
to be ECU 16.1 billion (USA: 25.7 - Japan: 8.0). Between 
1986 and 1989, the annual average growth in consumption was 
9.5% (USA: 9.9% - Japan: 8.6%). The number of Jobs in this 
branch of industry within the Community totalled over 
200 000 in 1990. 
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In view of the rapid speed of innovation in this sector, 
Community legislation will provide an appropriate framework 
which will help to maintain and to promote this favourable 
deve I opment. 
The proposal for a directive has been designed and 
structured, as regards technical requirements, in the light 
of the Council Resolution of 7 May 1985 on a new approach to 
technical harmonization and standardization The 
legislators already applied the principles set out in the 
abovementioned Resolution with the adoption of Council 
Directive 90/385/EEC of 20 June 1990 relating to active 
implantable medical devices This proposal therefore 
includes what has been achieved with that Directive and 
transposes it to the medical devices which it covers. 
The implementation of the concept of reference to standards 
will be facilitated by the fact that some of the harmonized 
European standards, in particular those of a horizontal 
nature, will already be available from the application of 
the Directive relating to active implantable medical 
devices. Furthermore, important work on the establishment of 
a sectoral system of harmonized standards has already been 
started by CEN/CENELEC. 
The part of the directive relating to procedures for the 
assessment of conformity is based on the modular approach 
set out in Council Decision 90/683/EEC of 13 December 1990 
The approach followed with regard to the assessment of 
conformity enables a distinetion to be made with regard to 
verifications carried out by a third party according to the 
nature of the potential risk inherent in medical devices. 
For this reason and in view of the diversity of products 
concerned, the devices covered by the directive have been 
divided into four classes for the purpose of assessment 
procedures . 
The intervention of the certification bodies (notified 
bodies) has been graded. For devices in Class I, conformity 
is established as a general rule under the responsibility 
of the manufacturer alone. Class Ma devices require, in 
view of the risks more closely associated with manufacture, 
the intervention of a notified body with regard to the 
manufacture stage. For devices in Classes Mb and III, on 
the other hand, verification by a notified body is 
necessary with regard to design and the manufacturing 
stage. Furthermore, Class III devices which are critical 
devices should, as a general rule, undergo a clinical 
evaluation under the responsibility of the manufacturer. 
The conformity of their design must be explicitly certified 
by a notified body before they are placed on the market. 
CD OJ No C 136, 
ic) OJ He L 1 89 , 
(3) OJ No L 380 4.6.1985, p. 1 . 
2 C . 7. i 9 9 0, p. 17. 
31.12. 1990, p 13 
I I . CONTENTS OF THE PROPOSAL 
1 • Article 1 - Scope 
Several definitions, in particular those of a "medical 
device", a "custom-made device" and a "device intended for 
clinical investigation" have been taken from the Directive 
relating to active implantable medical devices. Since the 
scope of this proposal is broader than that of the 
abovementioned Directive, a few slight amendments have 
therefore been made. 
The term "medical device" means products the function of 
which is solely or principally medical. A series of products 
whose function is not essentially medical are therefore 
excluded from the scope, even if these products may be used 
to prevent disease or alleviate a handicap, e.g. cosmetic 
products, multiple-use data-processing equipment. 
The medical function of a medical device may be fulfilled 
either by means of a product used on its own or as the 
result of the combination of several products, e.g. 
disposable tubings combined with an infusion pump. 
The criterion for the distinction between a medical device 
and a medicinal product is the principal action produced. A 
product which achieves its principal action by 
pharmacological, immunological or metabolic means is not 
considered to be a medical device. However, a medical device 
may include a medicinal substance as an integral part in 
order to increase its effectiveness, e.g. a heparin-coated 
catheter . 
Where the action produced by the presence of the medicinal 
substance is secondary to the principal action of the 
device, the conformity assessment procedure for authorizing 
the placing of the product concerned on the market is 
covered by this proposal for a directive. As far as safety 
aspects concerning the presence of the substance are 
concerned, the verifications required are carried out, where 
appropriate, by analogy to the methods contained in 
D i rect i ve 75/318/EEC. 
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On the other hand, where a device is intended to administer 
a medicinal product and therefore constitutes a container 
for that product, e.g. a pre-filled syringe, the aspects 
relating to the safety of the device are covered by this 
proposal, while the placing of the medicinal product on the 
market is subject to the Community legislation relating to 
medicinal products (see Article 1, para. 3). 
The key legal definitions include definitions of "placing on 
the market" and the "manufacturer". The "placing on the 
market" means the physical transfer of a medical device from 
the manufacturer or a person authorized by him to the 
distributor or user. Placing on the market must not be 
confused with the right, under the directive, to market 
medical devices in the European Community. The definition of 
the manufacturer is useful in order to be able to determine 
the natural or legal persons subject in particular to the 
conformity assessment procedures (Article 10). 
The scope of this proposal includes medical devices which 
emit ionizing radiation. It therefore specifies the 
requirements relating to the design and manufacture of the 
equipment concerned and the conformity assessment 
procedures. The directive does not, however, affect the 
authorization required under Directive 80/836/Euratom for 
the putting into service and use of such equipment. 
Articles 2 and 3 
These are conventional Articles based on the new approach 
relating to placing on the market, putting into service and 
essential requirements. 
Article 4 - Free movement, devices intended for special 
purposes 
In addition to the conventional clause concerning free 
movement, this Article refers to devices intended for 
special purposes, i.e. devices intended for clinical 
investigation and custom-made devices. 
Devices intended for clinical investigation are made 
available to medical practitioners when total compliance 
with the essential requirements still has to be established 
so that the device can undergo an assessment of conformity 
procedure. The carrying out of clinical investigations 
specifically makes it possible to confirm conformity with 
the relevant essential requirements. Such devices therefore 
do not bear the CE mark. 
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Custom-made devices are made in accordance with the 
prescription of a medical specialist or any other authorized 
person giving the specific design characteristics of the 
device concerned. Compliance with the requirements of the 
directive is therefore established under the Joint 
responsibility of the manufacturer and the person issuing 
the prescription and this is why such devices do not have to 
bear the CE mark. 
Article 5 - Reference to standards 
The reference to harmonized standards clause is based on the 
Council Resolution of 7 May 1985. 
By means of the reference to certain monographs of the 
European Pharmacopoeia in paragraph 2, the Community is 
discharging the obligations incumbent on the Member States 
pursuant to the Convention of 22 July 1964 on the 
preparation of a European Pharmacopoeia. 
In the field of the medical devices covered by this 
proposal, the European Pharmacopoeia has prepared several 
monographs relating in particular to sutures and the 
interaction between certain materials used for devices and 
medicinal products. Subject to Article 5, paragraph 2, these 
monographs will have the same status, under this proposal, 
as harmonized standards. The application of the monographs 
will therefore remain voluntary. 
The Commission has proposed to the CEN and the European 
Pharmacopoeia the conclusion of a memorandum of 
understanding to determine the respective fields of activity 
and to establish collaboration in areas of common interest. 
Articles 6 and 7. - Comm i t tees 
Regardless of the conventional role of the Committee set up 
under Directive 83/189/EEC (cf. Article 5(3)), the field of 
activity of the Advisory Committee set up under Directive 
90/385/EEC has been extended to the sector covered by the 
proposal. Any matter relating to the implementation and 
practical application of the Directive may be brought before 
this Comm i 11ee. 
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With regard to the classification of medical devices into 
four classes of products (see Articles 8 and 12), regulatory 
measures have to be laid down at Community level for the 
products concerned. In view of the nature of these measures 
and the consequences as regards the level of intervention of 
third parties, the measures should be adopted in accordance 
with the "Regulatory Committee" procedure (variant Ilia of 
Council Decision 87/373/EEC of 13 July 1987 laying down the 
procedures for the exercise of implementing powers conferred 
on the Commission). 
Article 8- Safeguard clause 
This Article is based on the Council Reso 
7 May 1985 concerning the new approach. ut i on of 
Articles 9 and 13 - Classification 
Medical dev.ces are divided into four product classes in 
order to be able to decide on the appropriate level of 
intervention by the notified bodies. The classification 
rules set out in Annex 9 enable manufacturers to classify 
their products according to the relevant class. Where there 
is doubt, manufacturers may contact the competent 
authorities which, for their part, may, if necessary, 
initiate the Community decision-making process. 
Decisions may have to be taken with regard to the 
classification of medical devices in particular where: 
the classification rules and the Commission guidelines do 
not enable a straightforward classification to be made-, 
the experience obtained with specific families of 
products justifies a reclassification by way of 
derogation from the classification rules; 
the classification rules need to be adjusted in the light 
of technical development and/or experience with given 
dev i ces . 
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Article 10 - Information on incidents occurring following 
placing of devices on the market 
This Article sets up a Community warning system regarding 
incidents occurring with devices already placed on the 
market. This system will enable the Member States to take 
appropriate measures early on where an incident suggests 
that, because of a design or manufacturing fault, a device 
may seriously damage the health of patients or users. 
The obligations on manufacturers to notify certain incidents 
are set out in Annex 2, point 3.1, Annex 4, point 3, Annex 
5, point 3.1, and Annex 6, point 3.1. Each Member State must 
set up a central unit to record and evaluate the reports 
obtained. Where measures have to be taken by the national 
authorities, the Member State concerned must inform the 
other Member States and the Commission. 
Article 11r Annexes 2 to 7 - Conformity assessment 
procedures 
Suitable conformity assessment procedures have been selected 
from among those adopted in Council Decision 90/683/EEC of 
13 December 1990 and supplemented according to sectoral 
requirements. The minor additions made refer in particular 
to the documentation required, the safety of combined 
devices, sterilization procedures and clinical data. The 
following procedures apply to the four classes of devices: 
C I ass I the manufacturer alone is responsible for the 
assessment of conformity (module A of Council 
Decision 90/683/EEC) 
C I ass I I a the manufacturer himself is responsible for 
assessing the product design. The 
intervention of a notified body is required 
at the production stage (module A combined 
with either modules D, E or F). Furthermore, 
the manufacturer may opt for full quality 
assurance (module H), although the procedure 
specified in that module is more restrictive 
than those mentioned above. 
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C I ass I I b the design and manufacture of the product 
must be referred to a notified body. The 
manufacturer may follow either the full 
quality assurance procedure (module H) or 
submit a prototype for type-examination 
(module B). In the case of the latter, the 
manufacturer must also apply one of the 
procedures referred to in modules D, E or F 
- Class I I I the procedures are broadly the same as those 
set out for Class Mb. However, if full 
quality assurance is applied (module H) the 
file relating to the product design must be 
examined. Furthermore, regardless of the 
procedure followed the design file must as a 
general rule include an assessment of 
conformity based on clinical data (see 
Annex 10, po i nt 1.1). 
The manufacturers' choice of several procedures will make it 
possible to select the most appropriate procedure taking 
account in particular of the pre-existing regulatory system 
and the nature and size of the company. 
10 Article 12 - Assembly and sterilization 
This Article refers to assembly and sterilization activities 
carried out commercially. It applies to devices already 
bearing the CE mark. The person who carries out the 
activities concerned is not considered to be the 
manufacturer as legally defined where the activities are 
carried out in accordance with the manufacturer's 
i nst ruct ions. 
If, however, assembly and sterilization go beyond the limits 
laid down by the manufacturer of the devices, they are 
specific manufacturing activities which are then subject to 
the procedures set out in Article 10. 
The procedures referred to in Article 11 apply regardless of 
the classification of the device. 
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11• Article 14 - Registration of persons responsible for placing 
devices on the market 
This Article applies to devices which are not subject to 
inspection by a notified body before being placed on the 
market. These are the Class I devices and custom-made 
devices. For these devices, the manufacturer or person(s) 
responsible for placing them on the market must Inform the 
competent authorities of the address of their registered 
place of business and the category of devices concerned. 
This notification enables the Member States to have better 
control of the devices in question which are marketed in 
their territory and, if necessary, to take appropriate 
measures . 
12 Article 15 - Clinical investigation 
Clinical investigations may be necessary in order to confirm 
that a device fully complies with the essential 
requirements. The competent authorities of each Member State 
in which the investigations are carried out must be able to 
intervene, if necessary, to protect the health of patients 
and public order. Article 14, paragraph 2, lays down a tacit 
approval procedure for implantable and other devices in 
Class III. 
The right of intervention of the competent authorities is 
centred on considerations of public health and public order. 
For this reason, intervention by the authorities does not 
include a preliminary evaluation of other aspects which are 
the subject of the conformity assessment procedures. The 
role of an ethics committee in this context is to evaluate 
the acceptability of the plan of investigations from the 
viewpoint of patient health and ethical considerations. 
The competent authorities are not bound by the opinion 
expressed by an ethics committee. However, such an opinion 
may make it easier for them to examine the file. 
13. Articles 16 to 19 - Notified bodies,, EC mark 
These are Articles typical of the new approach directives 
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14. Article 20 - Confidentiality 
The observance of confidentiality is essential for the 
protection of specific data and because of the economic 
impact of the procedures for the parties concerned. 
15. Article 21 - Guidelines 
The documents referred to in the guidelines are based on the 
practice followed with regard to medicinal products as set 
out in Directive 89/341/EEC. The guidelines may provide 
useful information for the application of the directive, 
although they do not themselves have any legal force. They 
will cover aspects that are not dealt with in harmonized 
standards. 
16 Article 22 - Repeal and amendment of Directives 
Directive 76/764/EEC covers mer cur y-in-gI ass thermometers. 
It is an optional Directive. The products and features 
concerned are covered by the scope of this directive. 
The amendment of Directive 84/539/EEC restricts its scope to 
electro-medical equipment used in veterinary medicine. 
Equipment used in human medicine is covered by this 
proposa I. 
The purpose of amending Directive 90/385/EEC is to add to 
that Directive the general provisions in this proposal so as 
to apply them to all medical devices. The existing 
provisions of Directive 90/385/EEC are not affected. The 
amendments will therefore not have any effect on the 
transposition of the abovementioned Directive. 
17. Article 23 - Implementation, transitional provisions 
Article 23, paragraph 4, provides for the optional 
application of the directive up to June 1997 to medical 
devices which must undergo certification by a third party. 
This period is necessary in order to avoid the additional 
certification workload which would arise with a shorter 
transitional period. To avoid the unnecessary repetition of 
tests and verifications, Article 23, paragraph 3, states 
that the notified bodies must take account of the results of 
tests and verifications already carried out under pre­
existing national regulations. 
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18. Annex 1 - Essential requirements 
This Annex is largely based on Directive 90/385/EEC. 
19. Annex 8 - Procedures for devices for special purposes 
The procedures and statements referred to in this Annex 
apply to custom-made devices and devices intended for 
clinical investigations. They are based on the solution 
adopted in the Council Directive relating to active 
implantable medical devices. 
2 0. Annex 9 - Classification rules 
This Annex lays down the rules for the classification of 
medical devices for the application of the conformity 
assessment procedures. The concept of classification is 
essentially based on the vulnerability of the human body 
following the use of a medical device. It also takes 
account of the consequences of functional defects in medical 
devices. The basic criteria for the classification rules 
are as foilows: 
contact or interaction of a device with the human body; 
contact with injured skin-, 
the invasive nature of a device with regard to the 
orifices of the human body or of a surgical device; 
implantation of a device in the body; 
contact with vital organs (heart, central nervous 
system) ; 
the delivery of energy or substances into or onto the 
body . 
On the above basis, devices which do not enter into contact 
or interact with the body are generally classified in Class 
I . 
Devices which are invasive or implantable or which interact 
with the body are largely (apart from certain particular 
aspects) in Class Ma or Mb. 
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A small number of devices concerning in particular the 
functions of vital organs are in Class III. Devices which 
are activated by an energy source and which in principle 
should be in Class III are already covered by the Directive 
relating to active implantable medical devices. The 
provisions of that Directive correspond to those laid down 
for CI ass I I I dev i ces. 
21 Annex 10 - Clinical evaluation 
Annex 10 has been adopted from the Directive relating to 
active implantable medical devices. It specifies the subject 
of the clinical data and the procedures to be followed for 
obtaining the data. Clinical evaluation is carried out under 
the manufacturer's responsibility. It may be a feature 
required in the technical documentation referred to in the 
conformity assessment procedures. The harmonized provisions 
contained in this Annex will avoid repetition of the same 
clinical investigations in more than one Member State. 
2 2. Annexes 11 and 12 - Minimum criteria for the notified 
bod i es . EC mark 
These are Annexes typical of the new approach directives. 
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Proposal for a 
COUNCIL DIRECTIVE 
concerning medical devices 
THE COUNCIL OF THE EUROPEAN COMMUNITIES 
Having regard to the Treaty establishing the European Economic Community, 
and in particular Article 100a thereof, 
Having regard to the proposal from the Commission^), 
In cooperation with the European Par Iiament^2), 
Having regard to the opinion of the Economic and Social Committee^3), 
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 of medical devices are 
different; whereas the certification and inspection procedures for such 
devices differ from one Member State to another; whereas such disparities 
constitute barriers to trade within the Community-, 
Whereas the national provisions for the safety and health protection of 
patients, users and, where appropriate, other persons, with regard to the 
use of medical devices should be harmonized in order to guarantee the free 
movement of such devices within the internal market; 
(1) OJ No C 
(2) OJ No C 
(3) OJ No C 
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Whereas the 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, these provisions do not affect the ability of the 
Member States to implement the abovementioned measures provided Community 
law is complied with; 
Whereas medical devices should provide patients, users and third parties 
with a high level of protection and attain the performance 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; 
Whereas certain medical devices are intended to administer medicinal 
products within the meaning of Council Directive 65/65/EEC of 
26 January 1965 on the approximation of provisions laid down by law, 
regulation or administrative action relating to proprietary medicinal 
products^4), as last amended by Directive 89/381/EEC^5^; whereas, in 
such cases the placing of the medicinal product on the market is governed 
by Directive 65/65/EEC; whereas a distinction must be drawn between the 
abovementioned devices and medical devices incorporating, inter alia, 
substances which, if used separately, may be considered to be a medicinal 
substance within the meaning of Directive 65/65/EEC; whereas, in such 
cases, if the substances are incorporated in the medical devices to help 
them operate, the placing of the devices on the market is governed by this 
Directive; whereas, in this context, in the event of the bioavailability 
of such substances, the safety, quality and usefulness of the substances 
must be verified by analogy with the appropriate methods specified in 
Council Directive 75/318/EEC of 20 May 1975 on the approximation of the 
laws of the Member States relating to analytical, pharmaco-toxicological 
and clinical standards and protocols in respect of the testing of 
proprietary medicinal products*6^, as last amended by Directive 
89/341/EEC<7), 
(4) OJ No L 22, 9.2.1965, p. 369/65. 
(5) OJ No L 181, 28.6.1989, p. 44. 
(6) OJ No L 147, 9.6.1975, p. 1. 
(7) OJ No L 142, 25.5.1989, p. 11. 
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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 standardization<8), rules regarding the design and 
manufacture of medical devices 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 should be applied with discrimination to 
take account of the technological level existing at the time of design and 
of technical and economic considerations; 
Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation 
of the laws of the Member States relating to active implantable medical 
devices^9) is the first case of application of the new approach to the 
field of medical devices; whereas in the interest of uniform Community 
rules applicable to all medical devices, this Directive is based largely on 
the provisions of Directive 90/385/EEC; whereas, for the same reasons, 
Directive 90/385/EEC must be amended to insert the general provisions laid 
down in this D i rect i ve; 
Whereas the electromagnetic compatibility aspects form an integral part of 
the safety of medical devices; whereas this Directive should contain 
specific rules on this subject with regard to Council Directive 89/336/EEC 
of 3 May 1989 on the approximation of the laws of the Member States 
relating to electromagmetic compatibiIity(1°), as amended by Directive 
91/263/EEC<1D 
Whereas this Directive should include requirements regarding the design and 
manufacture of devices emitting ionizing radiation-, whereas this Directive 
does not affect the authorization required by Council 
Directive 80/836/Euratom of 15 July 1980 amending the Directives laying 
down the basic safety standards for the health protection of the general 
public and workers against the dangers of ionizing radiâtion^12), as 
amended by Directive 84/467/Euratom(13), nor application of Council 
Directive 84/446/Euratom of 3 September 1984 laying down basic measures for 
(8) OJ No C 136, 4.6.1985, p. 1. 
(9) OJ No L 189, 20.7.1990, p. 17. 
(10) OJ No L 139, 23.5.1989, p. 19. 
(11) OJ No L 128, 23.5.1991, p. 1. 
(12) OJ No L 246, 17.9.1980, p. 1. 
(13) 0J No L 265, 5.10.1984, p. 4. 
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the radiation protection of persons undergoing medical examination or 
treatmentC14). whereas Council Directive 89/391/EEC of 12 June 1989 on the 
introduction of measures to encourage improvements in the safety and health 
of workers at work^15) and the specific directives on the same subject 
should continue to apply; 
Whereas this Directive does not affect Council Directive 76/768/EEC of 
27 July 1976 on the approximation of the laws of the Member States relating 
to cosmetic products(16), as last amended by Direct ive 91/184/EEC(17) -, 
whereas the assessment whether a product is subject to the abovementioned 
Directive or to this Directive must take account, in particular, of the 
intended purpose of the product in question and of the place of 
applicat ion; 
Whereas, in order to demonstrate conformity with these essential 
requirements and to enable conformity to be verified, it is desirable to 
have harmonized European standards to protect against the risks associated 
with the design, manufacture and packaging of medical devices-, whereas 
such harmonized European standards are drawn up by private-1 aw bodies and 
should retain their status as non-mandatory texts-, whereas, to this end, 
the European Committee for Standardization (CEN) and 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 régulâtions^18), as last amended by Commission 
Decision 90/230/EEC^19), and pursuant to the abovementioned general 
guidelines; whereas with regard to possible amendment of the harmonized 
standards, the Commission should be assisted by the Committee set up under 
(14) OJ No L 265, 5.10.1984, p. 1. 
(15) OJ No L 183, 29.6.1989, p. 1. 
(16) OJ No L 262, 27.9.1976, p. 169 
(17) OJ No L 91, 12.4.1991, p. 59. 
(18) OJ No L 109, 26.4.1983, p. 8. 
(19) OJ No L 128, 18.5.1990, p. 15. 
(4) 
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Directive 83/189/EEC-, whereas the measures to be taken must be defined in 
line with procedure I, as laid down in Council Decision 87/373/EEC^20); 
whereas, for specific fields, what already exists in the form of European 
Pharmacopoeia monographs should be incorporated within the framework of 
this Directive; whereas, therefore, several European Pharmacopoeia 
monographs may be considered equal to the abovementioned harmonized 
standards; 
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 directives^2Dt the 
Council has laid down harmonized conformity assessment procedures; 
whereas the application of these modules to medical devices enables the 
responsibility of manufacturers and certification bodies to be determined 
during conformity assessment procedures on the basis of the type of devices 
concerned; whereas the details added to these modules are justified by the 
nature of the verification required for medical devices-, 
Whereas it is necessary, essentially for the purpose of the conformity 
assessment procedures, to group the devices into four product classes; 
whereas the classification rules are based on the vulnerability of the 
human body taking account of the potential risks associated with the 
technical design and manufacture of the devices; whereas the conformity 
assessment procedures for Class I devices can be carried out, as a general 
rule, under the sole responsibility of the manufacturers in view of the low 
level of vulnerability associated with these products; whereas, for 
Class lia devices, the intervention of a certification body (notified body) 
should be compulsory at the production stage; whereas, for devices falling 
within Classes lib and III which, in case of malfunction, constitute a high 
risk potential, inspection by a notified body is required with regard to 
the design and manufacture of the devices; whereas Class III is set aside 
for the most critical devices for which explicit prior authorization with 
regard to conformity is required for them to be placed on the market; 
(20) OJ No L 197, 18.7.1987, p. 33. 
(21) OJ No L 380, 31.12.1990, p. 13 
- 20 -
Whereas in cases where the conformity of the devices can be assessed under 
the responsibility of the manufacturer the competent authorities must be 
able, particularly in emergencies, to contact a person responsible for 
placing the device on the market and established in the Community, whether 
the manufacturer or another person established in the Community and 
designated by the manufacturer for the purpose-, 
Whereas medical devices should, as a general rule, bear the EC mark 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, in the fight against AIDS and in the light of the conclusions of 
the Council adopted on 16 May 1989 regarding future activities on AIDS 
prevention and control at Community level^22), medical devices used for 
protection against the HIV virus must afford a high level of protection; 
whereas the design and manufacture of such products should be verified by a 
not i f i ed body -, 
Whereas the classification rules generally enable medical devices to be 
appropriately classified; whereas, in view of the diverse nature of the 
devices and technological progress in this field, steps must be taken to 
include amongst the implementing powers conferred on the Commission the 
decisions to be taken with regard to the proper classification or 
reclassification of the devices or, where appropriate, the adjustment of 
the classification rules themselves; whereas since these issues are 
closely connected with the protection of health, it is appropriate that 
these decisions should come under procedure lll(a), as provided for in 
Decision 87/373/EEC; 
Whereas it is appropriate that the Member States, as provided for by 
Article 100a of the Treaty, may take temporary measures to limit or 
prohibit the placing on the market and the use of medical devices in cases 
where they present a particular risk to the health of persons, provided 
that the measures are subject to a Community control procedure-, 
(22) OJ No C 185, 22.7.1989, p.8. 
- 21 -
Whereas the confirmation of compliance with the essential requirements may 
mean that clinical investigations have to be carried out under the 
responsibility of the manufacturer; whereas, for the purpose of carrying 
out the clinical investigations, appropriate means have to be specified for 
the protection of public health and public order; 
Whereas the application of some provisions of this Directive must be 
facilitated by means of guidelines published by the Commission; 
Whereas the protection of health and the associated controls may be made 
more effective by means of a medical device vigilance system at Community 
I eve I ; 
Whereas this Directive covers the medical devices referred to in Council 
Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of 
the Member States on clinical mercury-in-glass, maximum reading 
thermometers^23^, as last amended by Directive 84/414/EEC^24); whereas 
the abovementioned Directive must therefore be repealed; whereas for the 
same reasons Council Directive 84/539/EEC of 17 September 1984 on the 
approximation of the laws of the Member States relating to electro-medical 
equipment used in human or veterinary medicine^25) must be amended, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Definitions, scope 
1. This Directive shall apply to medical devices. It also covers the 
accessories to which the provisions for medical devices apply. 
2. For the purposes of this Directive, the following definitions shall 
apply: 
(23) OJ No L 262, 27.9.1976, p. 139. 
(24) OJ No L 228, 25.8.1984, p. 25. 
(25) OJ No L 300, 19.11.1984, p. 179 
- 22 -
(a) "medical device" (hereinafter referred to as "devices") means any 
instrument, apparatus, appliance, material or other article, 
including software, whether used alone or in combination, intended 
by the manufacturer to be used on human beings solely or principally 
for the purpose of: 
diagnosis, prevention, monitoring, treatment or alleviation of 
disease, 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. 
(b) "accessory" means an article which, while not a device, is required, 
according to the intended purpose attributed to it by the 
manufacturer, to enable a device to be used as specified. 
(c) "device used for in vitro diagnosis" means any device which is a 
reagent, reagent product, kit, instrument, equipment or system, 
whether used alone or in combination, intended by the manufacturer 
to be used solely or principally in vitro for the examination of 
substances derived from the human body with a view to providing 
information for the detection, diagnosis, control or treatment of a 
physiological state, of a state of health or disease, or of a 
congen i ta I abnormaI i ty. 
(d) "custom-made device" means any device specifically made in 
accordance with a duly qualified medical practitioner's written 
prescription which gives, under his responsibility, specific design 
characteristics and is intended to be used only for an individual 
named pat ient. 
The abovement ioned prescription may also be made out by any other 
person authorized by virtue of his professional qualifications to do 
so. 
- 23 -
Mass-produced devices which need to be adapted to meet the specific 
requirements of the medical practitioner or any other professional 
user are not considered to be custom-made devices. 
(e) "device intended for clinical investigation" means any device 
intended for use by a duly qualified medical practitioner when 
conducting investigations as referred to in point 2.1 of Annex 10 in 
an adequate human clinical environment. 
For the purpose of conducting clinical investigation, any other 
person who, by virtue of his professional qualifications, is 
authorized to carry out such investigation shall be accepted as 
equivalent to a duly qualified medical specialist. 
(f) "implantable device" means any device which is intended: 
to be totally or partially introduced into the human body or a 
natural or if ice or 
to replace an epithelial surface or the surface of the eye 
by surgical intervention, which is intended to remain after the 
procedure for at least 30 days, and which can only be removed by 
medical or surgical Intervention. 
(g) "manufacturer" means the natural or legal person with overall 
responsibility for the design, manufacture, packaging and labelling 
of a device before it is placed on the market on his own behalf, 
regardless of whether these operations are carried out by that 
person himself or on his behalf by a third party. 
The natural or legal person who assembles, packages, processes 
and/or labels one or more ready-made products and/or assigns to them 
their intended purpose as a device with a view to their being placed 
on the market on his own behalf is also considered to be a 
manufacturer. This sub-paragraph does not apply to the person who, 
while not a manufacturer within the meaning of the first 
sub-paragraph, assembles or adapts devices already on the market to 
their intended purpose for an individual patient. 
- 24 -
(h) "intended purpose" means the use for which the device is intended 
and for which it is suited according to the data supplied by the 
manufacturer on the labelling, in the instructions and/or in 
promotional materials. 
(i) "placing on the market" means the first making available in return 
for payment or free of charge of a device other than a device 
intended for clinical investigation, with a view to distribution 
and/or use on the Community market, regardless of whether it is new 
or fully refurbished. 
(j) "putting into service" means the stage when a device is ready for 
use for the first time on the Community market for its intended 
purpose. 
(k) "bioavailability" means the release of a substance into or onto the 
human body in such a way that the interaction with the body can 
reasonably be detected. 
3. Where a device is intended to administer a substance defined as a 
medicinal product within the meaning Article 1 of 
Directive 65/65/EEC, that substance shall be subject to the 
marketing authorization system provided for in that Directive. 
4. Where a device incorporates, as an integral part, a substance which, 
if used separately, may be considered to be a medicinal product 
within the meaning of Article 1 of Directive 65/65/EEC, that device 
must be assessed and authorized in accordance with this Directive. 
5. This Directive does not apply to: 
(a) devices used for in vitro diagnosis, 
(b) active implantable devices covered by Directive 90/385/EEC. 
6. This Directive is a specific directive within the meaning of 
Article 2(2) of Directive 89/336/EEC. 
- 25 -
7. This Directive does not affect the application of 
Directive 80/836/Euratom, nor of Directive 84/466/Euratom. 
8. This Directive does not affect the application of 
Directive 76/768/EEC. The assessment whether a product is subject 
to the abovementioned Directive or to this Directive shall take 
account, in particular, of the intended purpose of the product in 
question and of the place of application. 
Art i cle 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 do not compromise 
the safety and health of patients, users and, where applicable, other 
persons when properly installed, maintained and used in accordance with 
their intended purpose. 
Art i cle 3 
Essential reguirements 
The 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. 
Art i cle 4 
Free movement, devices intended for special purposes 
1. Member States shall not create any obstacles to the placing on the 
market or the putting into service within their territory of devices 
bear ing the EC mark. 
2. Member States shall not create any obstacles to: 
devices intended for clinical investigation being made 
available to medical specialists or authorized persons for 
that purpose if they meet the conditions laid down in 
Article 15 and in Annex 8. 
- 26 -
custom-made devices being placed on the market and put into 
service if they meet the conditions laid down in Article 11 in 
combination with Annex 8-, Class Ma, lib and III devices shall 
be accompanied by the statement referred to in Annex 8. 
These devices shall not bear the EC mark. 
3. At trade fairs, exhibitions, demonstrations, etc. Member States 
shall not create any obstacles 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. 
4. Member States may require the information referred to in points 13.3 
and 13.6 of Annex 1 to be in their national language(s) when a 
device reaches the final user, regardless of whether it is for 
professional or other use. 
Art icle 5 
Reference to standards 
1. Member States shall presume compliance with the essential 
requirements referred to in Article 3 in respect of devices which 
are in conformity with the relevant provisions of the harmonized 
standards, the references of which have been published in the 
Official Journal of the European Communities. Member States shall 
publish the references of the national standards which transpose the 
abovementioned harmonized standards into national law. 
2. For the purposes of this Directive, reference to harmonized 
standards also includes the monographs of the European Pharmacopoeia 
on surgical sutures and on interaction between medicinal products 
and materials used as containers for devices, the references of 
which have been published in the Official Journal of the European 
Commun i t i es. 
- 27 -
3. Where the Commission, whether on its own initiative or at the 
request of one of the Member States, considers that the harmonized 
standards do not entirely meet the essential requirements referred 
to in Article 3, the measures to be taken by the Member States 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). 
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. 
2. 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. 
Art icle 7 
Committee on Medical Devices 
1. The Commission shall be assisted by the committee set up by 
Article 6(2) of Directive 90/385/EEC. 
- 28 -
2. 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 
major ity. 
If, on the expiry of a period of three months from the date of 
referral to the Council, the Council has not acted, the proposed 
measures shall be adopted by the Commission. 
3. The committee may examine any question connected with implement ion 
of this Direct ive. 
Art icle 8 
Safeguard clause 
1. Where a Member State ascertains that the devices, 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, 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: 
- 29 -
(a) failure to meet the essential requirements referred to in 
Art icle 3; 
(b) incorrect application of the standards referred to in 
Article 5, in so far it is claimed that the standards have 
been applied; 
(c) shortcomings in the standards themselves. 
These measures are applicable until the entry into force of the act 
provided for in paragraph 2. 
2. The measures adopted under paragraph 1 shall be confirmed and 
extended, possibly amended, to the whole Community or repealed by an 
act of the Commission. 
However, where the measures were adopted under paragraph 1 on the 
ground of a shortcoming in the standards provided for in Article 5, 
the procedure laid down in Article 6(2) is applicable. 
3. Where a non-complying device bears the EC mark, the competent 
Member State shall take appropriate action against whomsoever has 
affixed the mark and shall inform the Commission and the other 
Member States thereof. 
4. The Commission shall ensure that the Member States are kept informed 
of the progress and outcome of this procedure. 
Art icle 9 
Classification 
1. Devices shall be divided into Classes I, lia, Mb and III. 
Classification shall be carried out in accordance with the 
classification rules set out in Annex 9. 
- 30 -
2. Where there is doubt over the classification resulting from 
application of the rules contained in Annex 9, the manufacturer or 
his authorized representative established in the Community may ask 
the competent authorities to take a decision. In the event of a 
dispute between the manufacturer and the notified body concerned 
defined in Article 16 resulting from the application of the 
abovementioned rules, the latter shall refer the matter to the 
competent authorities who will reach a decision. 
3. The classification rules set out in Annex 9 may be adapted in 
accordance with the procedure referred to in Article 7(2) in the 
light of technical progress and any information which becomes 
available under the information system provided for in Article 10. 
Art icle 10 
Information on incidents occurring following placing 
of devices on the market 
1. 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 a Class Ma, Mb or III device is recorded and 
evaluated in a centralized manner: 
(a) any deterioration in the characteristics and/or performance of 
a device, as well as any inaccuracies in the labelling or the 
instruction leaflet which might lead to or might have led to 
the death of a patient or user or to a serious deterioration 
in his state of health; 
(b) any technical or medical reason connected with the device 
leading to systematic recall of devices of the same type by 
the manufacturer. 
- 31 -
2. Where a Member State obliges medical practitioners or the medical 
institutions 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. 
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. The Commission shall adopt the necessary measures concerning the 
functioning of the information system referred to in paragraphs 1, 2 
and 3 and the presentation of information. 
Article 11 
Conformity assessment procedures 
1. In the case of devices failing within Class III, other than devices 
which are custom-made or intended for clinical investigations, the 
manufacturer shall, in order to affix the EC mark, either: 
(a) follow the procedure relating to the EC declaration of 
conformity set out in Annex 2 (full quality guarantee), or 
(b) follow the procedure relating to EC type-examination set out 
in Annex 3, coupled with: 
(i) the procedure relating to EC verification set out in 
Annex 4, or 
(ii) the procedure relating to the EC declaration of 
conformity set out in Annex 5 (production quality 
guarantee). 
- 32 -
2. In the case of devices falling within Class Ma, other than devices 
which are custom-made or intended for clinical investigations, the 
manufacturer shall, in order to affix the EC mark, follow the 
procedure relating to the EC declaration of conformity set out in 
Annex 7, coupled with either: 
(a) the procedure relating to EC verification set out in Annex 4, 
or 
(b) the procedure relating to the EC declaration of conformity set 
out in Annex 5 (production quality guarantee), or 
(c) the procedure relating to the EC declaration of conformity set 
out in Annex 6 (product quality guarantee). 
Instead of applying these procedures, the manufacturer may also 
follow the procedure referred to in paragraph 3(a). 
3. In the case of devices falling within Class lib, other than devices 
which are custom-made or intended for clinical investigations, the 
manufacturer shall, in order to affix the EC mark, either: 
(a) follow the procedure relating to the EC declaration of 
conformity set out in Annex 2 (full quality guarantee); in 
this case, point 4 of Annex 2 is not applicable-, or 
(b) follow the procedure relating to EC type-examination set out 
in Annex 3, coupled with: 
(i) the procedure relating to EC verification set out in 
Annex 4, or 
(ii) the procedure relating to the EC declaration of 
conformity set out in Annex 5 (production quality 
guarantee), or 
(Mi) the procedure relating to the EC declaration of 
conformity set out in Annex 6 (product quality 
guarantee). 
- 33 -
4. In the case of devices falling within Class I, other than devices 
which are custom-made or intended for clinical investigations, the 
manufacturer shall follow the procedure referred to in Annex 7 and 
draw up the EC declaration of conformity required before placing the 
device on the market. 
5. In the case of custom-made devices, the manufacturer shall follow 
the procedure referred to in Annex 8 and draw up the statement set 
out in that Annex before placing each device on the market. 
6. During the conformity assessment procedure for a device, the 
manufacturer and/or the notified body shall take account of the 
results of any assessment and verification operations which, where 
appropriate, have been carried out in accordance with this Directive 
at an intermediate stage of manufacture. 
7. The manufacturer may instruct his authorized representative 
established in the Community to initiate the procedures provided for 
in Annexes 3, 4, 7 and 8. 
8. 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 not i f ied. 
9. Decisions taken by the notified bodies in accordance with Annexes 2 
and 3 shall be valid for a maximum of five years and may be extended 
on application for further periods of five years. 
10. The records and correspondence relating to the procedures referred 
to in paragraphs 1 to 5 shall be in an official language of the 
Member State in which the procedures are carried out or in a 
language acceptable to the notified body. 
- 34 -
Art icle 12 
Assembly and sterilization 
Any natural or legal person who assembles devices bearing the EC 
mark for their intended purpose and within the limits of use 
specified by their manufacturers with regard to their compatibility 
with other devices in order to put them on the market in the form of 
a system, kit or operation pack shall draw up a declaration in which 
he states that: 
(a) he has verified the mutual compatibility of the devices which 
make up the system, kit or operation pack in accordance with 
the manufacturers' instructions and that assembly has been 
carried out in accordance with these instructions; 
(b) the system, kit or operation pack has, where applicable, been 
packaged in accordance with the manufacturers' instructions or 
the limits applicable to the various devices; 
(c) all of the activities referred to in (a) and (b) are subjected 
to appropriate methods of control and inspection. 
Any such system, kit or operation pack shall not bear any additional 
EC mark. It shall be accompanied by the information referred to in 
point 13 of Annex 1 which includes, where appropriate, the 
information supplied by the manufacturers of the devices which have 
been assembled. 
Any natural or legal person who, in the framework of an activity 
referred to paragraph 1, sterilizes devices bearing the EC mark, 
shall, at his choice, follow one of the procedures referred to in 
Annex 4 or 5. The application of the abovementioned Annexes and the 
intervention of the notified body are limited to the aspects of the 
procedure relating to the obtaining of sterility. The person shall 
draw up a declaration stating that sterilization has been carried 
out in accordance with the manufacturer's instructions. 
(6) 
- 35 -
3. This Article does not apply if one of the devices concerned does not 
bear the EC mark or if the EC mark for one of the devices has been 
affixed for a different intended purpose. 
Article 13 
Decisions with regard to classification, derogation clause 
1. Where a Member State considers that 
(a) application of the classification rules set out in Annex 9 
requires a decision with regard to the classification of a 
given device or family of devices, or 
(b) a given device or family of devices should be classified, by 
way of derogation from the provisions of Annex 9, in another 
class, or 
(c) the conformity of a device or family of devices should be 
established, by way of derogation from the provisions of 
Article 11, by applying solely one of the given procedures 
chosen from among those referred to in Article 11, 
it shall submit a duly substantiated request to the Commission and 
ask it to take the necessary measures. Where appropriate, these 
measures shall be adopted in accordance with the procedure referred 
to in Article 7(2). 
2. The Commission shall inform the Member States of the measures taken 
and, where appropriate, publish the relevant parts of these measures 
in the Official Journal of the European Communities. 
- 36 -
Article 14 
Registration of persons responsible for placing devices on the market 
1. Any manufacturer who, on his own behalf, places devices on the 
market in accordance with the procedures referred to in 
Article 11(4) and (5) shall inform 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 and the category of 
devices concerned. 
2. Where a manufacturer who places devices referred to in paragraph 1 
on the market on his own behalf does not have a registered place of 
business in a Member State, he shall designate the person(s) 
responsible for marketing them and established in the Community. 
These persons shall inform the competent authorities of the 
Member State in which they have their registered place of business 
of the address of the registered place of business and the category 
of devices concerned. 
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. 
Art icle 15 
Clinical investigation 
1. In the case of devices falling within Classes I, Ma and Mb which 
are intended for clinical investigations, the manufacturer, or his 
authorized representative established in the Community, shall follow 
the procedure referred to in Annex 8 and keep the statement 
concerned at the disposal of the competent authorities. 
2. In the case of devices falling within Class III and implantable 
devices falling within Classes Ma or Mb intended for clinical 
investigations, the manufacturer, or his authorized representative 
established in the Community, shall follow the procedure referred to 
in Annex 8 and, at least 45 days before the commencement of the 
investigations, submit the statement referred to in the 
abovementioned Annex to the competent authorities of the 
Member State in which the investigations are to be conducted. 
- 37 -
The manufacturer may commence the relevant clinical investigations 
at the end of a period of 45 days after notification, unless the 
competent authorities have notified him within that period of a 
decision to the contrary based on considerations of public health or 
pub Iic order. 
3. The clinical investigations must be conducted in conformity with the 
provisions of Annex 10. The provisions of Annex 10 shall be 
adjusted in accordance with the procedure laid down in Article 7(2). 
4. The Member States shall, if necessary, take the appropriate steps to 
ensure public health and public order. 
5. The manufacturer or his authorized representative established in the 
Community shall keep the report referred to in point 2.3.7 of 
Annex 10 at the disposal of the competent authorities. 
6. The provisions of paragraphs 1 and 2 do not apply where the clinical 
investigations are conducted using devices which are authorized in 
accordance with Article 11 to bear the EC mark unless the aim of 
these investigations is to use the devices for a purpose other than 
that referred to in the relevant conformity assessment procedure. 
The relevant provisions of Annex 10 remain applicable. 
Article 16 
Not if led bodies 
1. The Member States shall notify the other Member States and the 
Commission of the bodies which they have designated for carrying out 
the tasks pertaining to the procedures referred to in Articles 11 
and 18 and the specific tasks for which the bodies have been 
designated. In this Directive, these bodies are referred to as 
"not ified bodies". 
The Commission shall allocate an identification number to these 
bodies and inform them and the Member States of it. It 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. 
38 -
2. Member States shall apply the minimum criteria set out in Annex 11 
for the designation of bodies. Bodies that meet the criteria laid 
down in the relevant harmonized standards shall be presumed to meet 
the relevant minimum criteria. 
3. A Member State that has notified a body shall withdraw that 
notification if it finds that the body no longer meets the criteria 
referred to in paragraph 2. It shall immediately inform the other 
Member States and the Commission thereof. 
4. The notified body and the manufacturer, or his 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 2 to 6. 
Article 17 
EC marking 
1. Devices, other than devices which are custom-made or intended for 
clinical investigations, considered to meet the essential 
requirements referred to in Article 3 must bear the EC mark of 
conformity when they are placed on the market. 
2. The EC mark of conformity, as shown in Annex 12, must appear in a 
visible, legible and indelible form on the device, where practicable 
and appropriate, and/or on the sales packaging and the instruction 
leaflet. 
It shall be accompanied by the identification number of the notified 
body responsible for implementation of the procedures set out in 
Annexes 2, 4, 5 and 6 and the last two digits of the year in which 
the mark was affixed. 
3. In the event of a significant change in the intended purpose of a 
device, the EC mark may be affixed only if the manufacturer or, 
where appropriate, his authorized representative established in the 
Community, has followed the applicable procedures in accordance with 
Article 11. 
- 39 -
4. It is prohibited to affix marks which may be confused with the EC 
mark of conformity. 
Article 18 
Obligations of the notified body in the case of a wrongly affixed mark 
Where it is found that the EC mark has been wrongly affixed, the notified 
body which carried out the assessment of conformity shall take appropriate 
measures and forthwith inform the competent Member State thereof. The 
competent Member State shall inform the other Member States and the 
Commission thereof. 
Article 19 
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 the carrying out of clinical 
investigations, or 
(b) to withdraw devices from the market, 
shall state the exact grounds on which it is based. Such decisions 
shall be notified without delay to the party concerned, who shall at 
the 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 to withdraw devices from the market, 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. 
- 40 -
Article 20 
Confident iality 
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 all 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. 
Article 21 
Guide!ines 
The Commission shall adopt the necessary guidelines for the uniform 
application of this Directive in respect in particular of: 
(a) the scope of the Directive, 
(b) the classification of devices, 
(c) the conformity assessment procedures. 
The Commission shall publish these guidelines in the Official Journal of 
the European Communities. 
Article 22 
Repeal and amendment of Directives 
1. Directive 76/764/EEC is hereby repealed with effect from 
1 July 1994. 
2. In the title and Article 1 of Directive 84/539/EEC, the words 
"human or" are deleted. 
- 41 -
3. The following paragraph 6 is added to Article 1 of 
Directive 90/385/EEC: 
"6. The following provisions of Council Directive 
../.../EEC^26) [on medical devices] also apply to 
active implantable medical devices: Article 1(2)(g) 
and (i); Article 11(6), (8) and (9); Article 13(1)(c) 
coupled with Article 7; Article 17(3); Article 19(2); 
Article 21 points (a) and (c) of the first paragraph." 
Art icle 23 
Implementation, transitional provisions 
1. Member States shall adopt and publish the laws, regulations and 
administrative provisions necessary to comply with this Directive 
not later than 31 December 1993. 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 16 within six 
months of notification of this Directive. 
When Member States adopt these provisions, these shall contain a 
reference to this Directive or shall be accompanied by such a 
reference at the time of their official publication. The 
procedure for such reference shall be adopted by Member States. 
Member States shall apply these provisions with effect from 
1 July 1994. 
2. Member States shall communicate to the Commission the texts of the 
provisions of national law which they adopt in the field covered by 
this Direct ive. 
(26) 
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3. Member States shall take the necessary action to ensure that the 
notified bodies which are responsible pursuant to Article 11(1) to 
(4) for the assessment of the conformity of devices already placed 
on the market prior to the implementation of this Directive take 
account of the results of tests and verifications already carried 
out under pre-existing national law in respect of such devices and 
of any other relevant information regarding the characteristics and 
performance of such devices. 
4. In the case of devices which, for the purposes of this Directive, 
must be the subject of one of the procedures referred to in Annexes 
2 to 6, Member States shall accept the placing on the market and 
putting into service of devices which conform to the rules in force 
in their territory on 30 June 1994 during the period up to 
30 June 1997. In the case of other devices lawfully placed on the 
market before 30 June 1994, Member States shall accept their being 
put into service during the period up to 30 June 1995. 
In the case of devices which have been subjected to EEC pattern 
approval in accordance with Directive 76/764/EEC, Member States 
shall accept their being placed on the market and put into service 
during the period up to 30 June 2004. 
Article 24 
This Directive is addressed to the Member States. 
Done at Brussels, For the Council 
The President 
(7) 
- 43 -
ANNEX 1 
ESSENTIAL REQUIREMENTS 
>• General requirements 
1. The devices must be designed and manufactured in such a way that, 
when used under the conditions and for the purposes intended, they 
will not compromise the clinical condition or the safety of the 
patients, users and, where applicable, other persons. The risks 
associated with the devices must be reduced to an acceptable level 
compatible with a high level of protection of health and safety. 
2. The solutions adopted by the manufacturer for the design and 
construction of the devices must conform to safety principles, 
taking account of the generally acknowledged state of the art. 
3. The devices must achieve the performances intended by the 
manufacturer, i.e. be designed and manufactured in such a way that 
they are suitable for one or more of the functions referred to in 
Article 1(2)(a), as specified by the manufacturer. 
4. The characteristics and performances referred to in Sections 1 and 3 
must not be adversely affected to such a degree that the clinical 
condition and safety of the patients and, where applicable, of other 
persons are compromised during the lifetime of the device as 
indicated by the manufacturer, when the device is subjected to the 
stresses which can occur during normal conditions of use. 
5. The devices must be designed, manufactured and packed in such a way 
that their characteristics and performances during their intended 
use are not adversely affected in the storage and transport 
conditions (temperature, humidity, etc.) laid down by the 
manufacturer. 
6. Any undesirable side-effects must constitute acceptable risks when 
weighed against the performances intended. 
- 44 -
II. Requirements regarding design and construction 
7. Chemical and Physical properties 
7.1 The devices must be designed and manufactured in such a way as to 
guarantee the characteristics and performances referred to in 
Section I on the "General requirements". Particular attention must 
be paid to: 
the choice of materials used, particularly as regards toxicity 
and, where appropriate, flammabiIity; 
the compatibility between the materials used and biological 
tissues, cells and body fluids, taking account of the intended 
purpose of the device. 
7.2 The devices must be designed, manufactured and packed in such a way 
as to minimize the risk posed by contaminants and residues to the 
persons involved in the transport, storage and use of the devices 
and to the patients, taking account of the intended purpose of the 
product. Particular attention must be paid to the tissues exposed 
and to the duration and frequency of exposure. 
7.3 The devices must be designed and manufactured in such a way that 
they can be used completely safely with the materials, substances 
and gases with which they enter into contact during normal use or 
routine treatment. 
7.4 Where a device incorporates, as an integral part, a substance which, 
if used separately, may be considered to be a medicinal product, as 
defined in Article 1 of Directive 65/65/EEC, and whose action in 
combination with the device can result in its bioavailability, the 
safety, quality and usefulness of the substance must be verified, 
taking account of the intended purpose of the device, by analogy 
with the appropriate methods specified in Directive 75/318/EEC, as 
last amended by Directive 89/341/EEC. 
7.5 The devices must be designed and manufactured in such a way as to 
minimize the health risks posed by substances leaking from the 
device dur ing use. 
- 45 -
8. Infection and microbial contamination 
8.1 The devices and manufacturing processes must be designed in such a 
way as to minimize the risk of infection to the patient. The design 
must allow easy handling and, where necessary, minimize 
contamination of the device by the patient or vice versa during use. 
8.2 Where a device incorporates animal or human tissues, the risks of 
cross-infect ion must be minimized by selecting appropriate tissues 
and using appropriate inactivation, conservation and test 
procedures. 
8.3 Sterile devices must be designed, manufactured and packed in a 
non-reusable pack and/or according to appropriate procedures to 
ensure that they are sterile when placed on the market and remain 
sterile, under the storage and transport conditions laid down, until 
the protective packaging is damaged or opened. 
8.4 Devices labelled sterile must have been sterilized by an 
appropriate, validated method. 
8.5 Packaging systems for non-sterile devices must keep the product 
without deterioration at the level of cleanliness stipulated and, if 
the devices are to be sterilized prior to use, minimize the risk of 
microbial contamination. 
8.6 The packs and/or label of the device must distinguish between 
identical or similar products sold in both sterile and non-sterile 
packaging. 
9. Construction and environmental properties 
9.1 If the device is intended for use in combination with other devices 
or equipment, 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 or in the instruction leaflet. 
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9.2 Devices must be designed and manufactured in such a way as to remove 
or minimize as far as possible: 
the risk of injury, in connection with their physical, 
including dimensional features; 
risks connected with reasonably foreseeable environmental 
conditions, such as magnetic fields, external electrical 
influences, electrostatic discharge, pressure or variations in 
pressure and acceleration; 
the risks of interference with other devices normally required 
for the investigations or for the treatment given; 
risks possibly arising from lack of maintenance and 
calibration, including: 
ageing of the materials used, 
loss of accuracy of any measuring or control mechanism. 
9.3 Devices must be designed and manufactured in such a way as to 
minimize the risks of fire or explosion during normal use and in 
failsafe condition. Particular attention must be paid to devices 
which must be exposed to or used in association with flammable 
substances or substances which could cause combustion. 
10. Devices with a measuring function 
10.1 Devices with a measuring function must be designed and manufactured 
in such a way as to provide sufficient accuracy and stability as 
specified by the manufacturer, taking account of the intended 
purpose of the device. 
10.2 The units on the measurement, monitoring and display scale must be 
designed in line with ergonomie principles, taking account of the 
intended purpose of the device. 
10.3 The measurements made by devices with a measuring function must be 
expressed in legal units conforming to the provisions of Council 
Directive 80/181/EEC(1), as last amended by Directive 
89/617/EEC<2>. 
(1) OJ No L 39, 15.2.1980, p. 40. 
(2) OJ No L 357, 7.12.1989, p. 28. 
_ 47 -
11. Protection against radiât Ion 
11.1 The devices must be designed and constructed in such a way that the 
radiation emitted will not attain dangerous levels. Where emission 
of dangerous levels of radiation is necessary for a specific medical 
purpose considered to outweigh the risks inherent in the emissions, 
it must be possible for the user to control the emissions. 
11.2 Devices emitting ionizing radiation must be designed and constructed 
in such a way as: 
(a) to ensure that the quantity and quality of radiation emitted 
can be adjusted and controlled; 
(b) to reduce exposure of the user at work and all unnecessary 
exposure of the patient. 
11.3 The operating instructions for devices emitting radiation must give 
detailed information on the nature of the devices, means of 
protecting the patient and user and on ways of avoiding mishandling 
and the risks inherent in installation. 
11.4 Devices emitting radiation must be designed and manufactured in such 
a way as to reduce unnecessary exposure of the patient and of the 
user as far as possible. 
11.5 Instruments, apparatus or appliances emitting radiation must be 
fitted with visual displays and/or audible warnings of radiation 
emissions. 
12- Requirements for medical devices connected to or equipped with an 
energy source 
12.1 Devices depending on software must be designed in such a way as to 
minimize the risks arising from errors in the program. 
12.2 Devices where the safety of the patients depends on an internal 
power supply must be equipped with a means of determining the state 
of the power supply. 
- 48 -
12.3 Devices where the safety of the patients depends on an external 
power supply must include an alarm system to signal any power 
failure. 
12.4 Devices intended to monitor one or more clinical parameters of a 
patient shall be equipped with appropriate alarm systems to alert 
the user of situations which could lead to death or severe 
deterioration of the patient's state of health. 
12.5 The 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 vicinity. 
12-6 Protection against electrical risks 
The devices must be designed and manufactured in such a way as to 
avoid, as far as possible, the risk of electric shocks during normal 
use and n single fault condition, provided the devices are 
installed correctly. 
12.7 Protection against mechanical and thermal risks 
12.7.1 The devices must be designed and manufactured in such a way as to 
protect the patient and user against mechanical risks connected 
with, for example, resistance, stability and moving parts. 
12.7.2 The 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. 
12.7.3 The 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. 
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12.7.4 The terminals and connectors to the electricity, gas or hydraulic 
and pneumatic energy supplies which the user has to handle must be 
designed and constructed in such a way as to minimize all possible 
risks. 
12.7.5 Accessible parts of the devices and their surroundings must not 
attain potentially dangerous temperatures under normal use. 
12.8 Protection against the risks posed to the patient by energy supplies 
or substances 
12.8.1 Devices for supplying the patient with energy or substances must be 
designed and constructed in such a way that the flow rate can be set 
and maintained accurately enough to guarantee the safety of the 
patient and of the user. 
12.8.2 Devices must be fitted with an interlock and/or alarm system to 
prevent and/or indicate any inadequacies in the flow rate which 
could pose a danger. 
12.9 The function of the controls and visual displays must be clearly 
specified on the devices. 
13. Information supplied by the manufacturer 
13.1 Each device must be accompanied by the information needed to use it 
safely and to identify the manufacturer, taking account of the 
training and knowledge of the potential users. 
This information comprises the details on the label and the data in 
the instruction leaflet. 
As far as practicable and appropriate, the information needed to use 
the device safely must be set out on the device itself and/or on the 
packaging for each unit or, where appropriate, on the sales 
packaging. If individual packaging of each unit is not practicable, 
the information must be set out in the leaflet supplied with one or 
more devices. 
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An instruction leaflet must be included in the packaging for every 
device. 
By way of exception, no such instruction leaflet is needed for 
devices in Class I or Class Ma if they can be used completely 
safely without any such instructions. 
13.2 Where appropriate, this information should take the form of symbols. 
Any symbols and identification colours used must conform to the 
harmonized standards. In areas for which no standards exist, the 
symbols and colours must be described in the documentation supplied 
with the device. 
13.3 The label must bear the following particulars: 
(a) the name or trade name and address of the manufacturer; 
(b) the details strictly necessary for the user to identify the 
device and the contents of the packaging-, 
(c) where appropriate, the word "STERILE"; 
(d) where appropriate, the batch code, preceded by the word "LOT", 
or the serial number; 
(e) where appropriate, an indication of the time limit for 
completely safe use, expressed as the year and month; 
(f) where appropriate, an indication that the device is for single 
use; 
(g) if the device is custom-made, the words "custom-made device"; 
(h) if the device is intended for clinical investigations, the 
words "exclusively for clinical investigations"; 
(i) any special storage and/or handling conditions; 
(j) any special operating instructions; 
(k) any warnings and/or precautions to take. 
(8) 
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13.4 If the intended purpose of the device is not obvious to the user, 
the manufacturer must clearly state it on the label and in the 
instruction leaflet. 
13.5 Wherever reasonable and practicable, the devices and detachable 
components must be identified, where appropriate in terms of 
batches, to allow all appropriate action to detect any potential 
risk posed by the devices and detachable components. 
13.6 Where appropriate, the instruction leaflet must contain the 
following particulars: 
(a) for devices in Class Mb or Class III the year of 
authorization to affix the EC mark; 
(b) the details referred to in Section 13.3, with the exception of 
points (d) and (e); 
(c) the performances referred to in Section 3 and any undesirable 
side-effects; 
(d) if the device must be installed with or connected to other 
medical devices or equipment in order to operate as required 
for its intended purpose, sufficient details of its 
characteristics to identify the correct devices or equipment 
to use in order to obtain a safe combination; 
(e) 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 needed 
to ensure that the devices operate properly and safely at all 
t imes-, 
(f) where appropriate, information to avoid certain risks in 
connection with implantation of the device-, 
(g) information regarding the risks of reciprocal interference 
posed by the presence of the device during specific 
investigations or treatment; 
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(h) the necessary Instructions in the event of damage to the 
sterile packaging and, where appropriate, details of 
appropriate methods of resteriIization; 
(I) if the device is reusable, information on the appropriate 
processes to allow reuse, including cleaning, disinfection, 
packaging and, where appropriate, resteriMzation, and any 
restriction on the number of reuses; 
(J) details of any further treatment or handling needed before the 
device can be used (for example, sterilization, final 
assembly, etc.); 
(k) in the case of devices emitting radiation for medical 
purposes, details of the nature, type, intensity and 
distribution of this radiation. 
The instruction leaflet must also include details allowing the 
medical staff to brief the patient on any contra-indications 
and any precautions to be taken. These details should cover 
in part icular: 
(I) precautions to be taken in the event of changes in the 
performance of the device; 
(m) precautions to be taken as regards exposure, in reasonably 
foreseeable environmental conditions, to magnetic fields, 
external electrical influences, electrostatic discharge, 
pressure or variations in pressure, acceleration, thermal 
ignition sources, etc.; 
(n) adequate information regarding the medicinal products which 
the device in question is designed to administer; 
(o) precautions to be taken against any special, unusual risks 
related to the disposal of the device. 
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ANNEX 2 
EÇ pEgARATIQN QF CQNFQRMITY 
(FUU, QUAIITY ASSURANCE SYSTEM) 
1. The manufacturer shall apply the quality system approved for the 
design, manufacture and final inspection of the products concerned, 
as specified in Sections 3 and 4, and shall be subject to the EC 
surveillance specified in Section 5. 
2. The declaration of conformity is the procedure whereby the 
manufacturer who fulfils the obligations imposed by Section 1 
ensures and declares that the products concerned meet the provisions 
of this Directive which apply to them. 
The manufacturer shall affix the EC mark in accordance with 
Article 17 and shall draw up a written declaration of conformity. 
This declaration shall cover a given number of identified specimens 
of the products manufactured and shall be kept by the manufacturer. 
The EC mark shall be accompanied by the identification number of the 
notified body which performs the tasks referred to in this Annex. 
3. Qua Iity system 
3.1 The manufacturer shall lodge an application for assessment of his 
quality system with a notified body. 
The application shall include: 
the name and address of the manufacturer; 
all the relevant information on the product or product 
category covered by the procedure; 
a written declaration that no application has been lodged with 
any other notified body for the same products; 
the documentation on the quality system-, 
an undertaking to fulfil the obligations imposed by the 
quality system approved; 
an undertaking to keep the approved quality system adequate 
and ef f icacious-, 
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an undertaking by the manufacturer to institute and keep 
updated a post-marketing surveillance system. This 
undertaking shall include an obligation for the manufacturer 
to notify the competent authorities of the following incidents 
immediately on learning of them: 
(i) any deterioration in the characteristics and/or 
performances of a device, as well as any inaccuracies in 
the instruction leaflet which might lead to or might have 
led to the death of a patient or user or to a serious 
deterioration in their state of health-, 
(ii) any technical or medical reason connected with the device 
leading to recall of devices of the same type by the 
manufacturer. 
3.2 Application of the quality system must ensure that the products 
conform to the provisions of this Directive which apply to them at 
every stage, from design to final inspection. All the elements, 
requirements and provisions adopted by the manufacturer for his 
quality system shall be documented in a systematic and orderly 
manner in the form of written policies and procedures. This quality 
system documentation must permit uniform interpretation of the 
quality policies and procedures such as quality programmes, quality 
plans, quality manuals and quality records. 
It shall include in particular an adequate description of: 
(a) the manufacturer's quality objectives; 
(b) the organization of the business and in particular: 
the organizational structures, the responsibilities of 
the managerial staff and their organizational authority 
where quality of design and manufacture of the products 
is concerned; 
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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 
var iants planned; 
the design specifications, including the standards which 
will be applied and a description of the solutions 
adopted to fulfil the essential requirements which apply 
to the products if the standards referred to in Article 5 
are not applied in fui I ; 
the techniques used to control and verify the design and 
the processes and systematic measures which will be used 
when the products are being designed; 
if the device is to be connected to other device(s) in 
order to operate as intended, proof must be provided that 
it conforms to the essential requirements when connected 
to any such device(s) having the characteristics 
specified by the manufacturer-, 
a statement indicating whether or not the device 
incorporates, as an integral part, a substance as 
referred to in Section 7.4 of Annex 1 whose action in 
combination with the device may result in its 
bioavailability and data on the tests conducted in this 
connect ion; 
the clinical data referred to in Annex 10-, 
the draft label and, where appropriate, instruction 
leaf let ; 
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(d) the inspection and quality assurance techniques at the 
manufacturing stage and in particular: 
the processes and procedures which will be used, 
particularly as regards sterilization, purchasing and the 
relevant documents; 
the product-identification procedures drawn up and kept 
up to date from drawings, specifications or other 
relevant documents at every stage of manufacture; 
(e) the appropriate tests and trials which will be carried out 
before, during and after manufacture, the frequency with which 
they will take place, and the test equipment used; it must be 
possible to trace back the calibration of the test equipment 
adequately. 
3.3 The notified body shall audit the quality system to determine 
whether it meets the requirements referred to in Section 3.2. It 
shall presume that quality systems which implement the relevant 
harmonized standards conform to these requirements. 
The assessment team shall include at least one member with past 
experience of assessments of the technology concerned. The 
assessment procedure shall include an inspection on the 
manufacturer's premises and, in duly substantiated cases, on the 
premises of the manufacturer's suppliers to inspect the 
manufacturing processes. 
The decision shall be notified to the manufacturer. It shall 
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. 
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The notified body shall assess the changes proposed and shall verify 
whether after these changes the quality system will still meet the 
requirements referred to in Section 3.2. It shall notify the 
manufacturer of its decision. This decision shall contain the 
conclusions of the inspection and a reasoned assessment. 
4. Examination of the design of the product 
4.1 In addition to the obligations imposed by Section 3, the 
manufacturer shall lodge an application for examination of the 
design dossier relating to the product which he plans to manufacture 
and which falls into the category referred to in Section 3.1. 
4.2 The application shall describe the design, manufacture and 
performances of the product in question. It shall include the 
documents needed to assess whether the product conforms to the 
requirements of this Directive, as referred to in Section 3.2(c). 
4.3 The notified body shall examine the application and, if the product 
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 
requirements of the Directive. The certificate shall contain the 
conclusions of the examination, the conditions of validity, the data 
needed for identification of the approved design and, where 
appropriate, a description of the intended purpose of the product. 
4.4 The applicant shall inform the notified body which issued the EC 
design-examination certificate of any significant change made to the 
approved design. Changes to the approved design must receive 
further approval from the notified body which issued the EC 
design-examination 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. 
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5. Surveillance 
5.1 The aim of surveillance is to ensure that the manufacturer duly 
fulfils the obligations imposed by the approved quality system. 
5.2 The manufacturer shall authorize the notified body to carry out all 
the necessary inspections and shall 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, calculations, 
tests, etc.; 
the data stipulated in the part of the quality system relating 
to manufacture, such as reports concerning inspections, tests, 
calibration and the qualifications of the staff concerned, 
etc. 
5.3 The notified body shall periodically carry out appropriate 
inspections and assessments to make sure that the manufacturer 
applies the approved quality system and shall supply the 
manufacturer with an assessment report. 
5.4 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 shall provide the 
manufacturer with an inspection report and, if a test has been 
carried out, with a test report. 
6. Administrative provisions 
6.1 The manufacturer shall, for a period ending at least five years 
after the last product has been manufactured, keep at the disposal 
of the national authorities: 
the declaration of conformity; 
the documentation referred to in the fourth indent of 
Sect ion 3.1 ; 
the changes referred to in Section 3.4; 
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the documentation referred to in Section 4.2; and 
the decisions and reports from the notified body as referred 
to in Sections 3.3, 4.3, 4.4, 5.3 and 5.4. 
6.2 The notified body shall communicate to the other notified bodies all 
relevant information concerning the quality system approvals issued, 
refused or withdrawn. 
7. ADD I icat ion to devices in Classes Ma and Mb 
In line with Article 11(2) and (3), this Annex may apply to products 
in Classes lia and Mb, subject to the following derogations: 
7.1 For products in Class Ma, by way of derogation from the final 
indent of Section 3.1, the manufacturer shall undertake to notify 
the competent authorities of the incidents referred to in the 
abovementioned indent immediately on learning of them and to 
institute and keep updated an appropriate internal system for this 
purpose. 
7.2 Section 4 shall not apply to products in Classes Ma and Mb. 
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ANNEX 3 
EC TYPE-EXAMINATION 
1. EC type-examination is the procedure whereby a notified body 
ascertains and certifies that a representative sample of the 
production covered fulfils the relevant provisions of this 
Directive. 
2. The application 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. 
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; 
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design drawings, methods of manufacture envisaged, in 
particular as regards sterilization, and diagrams of 
components, sub-assemblies, circuits, etc.; 
the descriptions and explanations necessary to understand the 
abovementioned drawings and diagrams and the operation of the 
product; 
a list of the standards referred to in Article 5, applied in 
full or in part, and descriptions of the solutions adopted to 
meet the essential requirements if the standards referred to 
in Article 5 have not been applied in full; 
the results of the design calculations, investigations, 
technical tests, etc. carried out; 
a statement indicating whether or not the device incorporates, 
as an integral part, a substance as referred to in Section 7.4 
of Annex 1 whose action in combination with the device may 
result in its bioavailability, and data on the tests conducted 
in this connect ion; 
the clinical data referred to in Annex 10; 
the draft label and, where appropriate, instruction leaflet. 
4. The notified body shall: 
4.1 examine and assess the documentation and verify that the type has 
been manufactured in conformity with that documentation; it shall 
also record the items designed in conformity with the applicable 
provisions of the standards referred to in Article 5, as well as the 
items not designed on the basis of the relevant provisions of the 
abovementioned standards; 
- 62 -
4.2 carry out or ask for the appropriate inspections 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 connected to other device(s) in order to operate 
as intended, proof must be provided that it conforms to the 
essential requirements when connected to any such device(s) having 
the characteristics specified by the manufacturer-, 
4.3 carry out or ask for the appropriate inspections 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 
inspections 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 inspection, 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. 
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7. Administrative provisions 
7.1 Each notified body shall communicate to the other notified bodies 
all relevant information on EC type-examination certificates and 
supplements issued, refused or withdrawn. 
7.2 Other notified bodies may obtain a copy of the EC type-examination 
certificates and/or the supplements thereto. The annexes to the 
certificates shall be made available to the other notified bodies on 
reasoned application, after informing the manufacturer. 
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ANNEX 4 
EC VERIFICATION 
1. EC verification is the procedure whereby the manufacturer or his 
authorized representative established in the Community ensures and 
declares that the products which have been subjected to the 
procedure set out in Section 4 conform to the type described in the 
EC type-examination certificate and meet the requirements of this 
Directive which apply to them. 
2. The manufacturer shall take all the measures necessary for the 
manufacturing process to ensure that the products 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 shall prepare documents defining 
the manufacturing process, in particular as regards sterilization 
where necessary, together with all the routine, pre-established 
provisions to be implemented to ensure homogeneous production and, 
where appropriate, conformity of the products with the type 
described in the EC type-examination certificate and with the 
requirements of this Directive which apply to them. The 
manufacturer shall affix the EC mark in accordance with Article 17 
and shall draw up a declaration of conformity. 
3. The manufacturer shall undertake to institute and keep updated a 
post-marketing surveillance system. This undertaking shall include 
an obligation for the manufacturer to notify the competent 
authorities of the following incidents immediately on learning of 
them: 
(i) any deterioration in the characteristics and/or performances 
of a device, as well as any inaccuracies in the instruction 
leaflet which might lead to or might have led to the death of 
a patient or user or to a serious deterioration in their state 
of health; 
- 65 -
(ii) any technical or medical reason connected with the device 
leading to recall of devices of the same type by the 
manufacturer. 
4. The notified body shall 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, at the 
choice of the manufacturer. 
5. Verification by examination and testing of every product 
5.1 Every product shall be examined individually and the appropriate 
tests defined in the relevant standard(s) referred to in Article 5 
or equivalent tests shall be carried out in order 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. 
5.2 The notified body shall affix, or have affixed, its identification 
number to each approved product and shall draw up a written 
certificate of conformity relating to the tests carried out. 
6. Statistical verification 
6.1 The manufacturer shall present the manufactured products in the form 
of homogeneous batches. 
6.2 A random sample shall be taken from each batch. The products which 
make up the sample shall be examined individually and the 
appropriate tests defined in the relevant standard(s) referred to in 
Article 5 or equivalent tests shall 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. 
- 66 -
6.3 Statistical control of products will be based on attributes, 
entailing a sampling system ensuring a limit quality corresponding 
to a probability of acceptance of 5%, with a non-conformity 
percentage of between 3 and 7%. The sampling method shall 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 shall affix, or have 
affixed, its identification number to each product and shall draw 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 shall take 
appropriate measures to prevent the batch from being placed on the 
market. In the event of frequent rejection of batches, the notified 
body may suspend the statistical verification. 
The manufacturer may, on the responsibility of the notified body, 
affix the notified body's identification number during the 
manufacturing process. 
7. Administrative provisions 
The manufacturer or the manufacturer's authorized representative 
shall, for a period ending at least five years after the last 
product has been manufactured, keep at the disposal of the national 
author it ies: 
the declaration of conformity; 
the documentation referred to in Section 2; 
the certificates referred to in Sections 5.2 and 6.4. 
8. Application to devices in Class Ma 
In line with Article 11(2), this Annex may apply to products in 
Class Ma, subject to the following derogations: 
- 67 -
8.1 By way of derogation from Sections 1 and 2, by virtue of the 
declaration of conformity the manufacturer ensures and declares that 
the products in Class Ma are manufactured in conformity with the 
technical documentation referred to in Section 3 of Annex 7 and meet 
the requirements of this Directive which apply to them. 
8.2 By way of derogation from Sections 1, 2, 5 and 6, the verifications 
conducted by the notified body are intended to confirm the 
conformity of the products in Class Ma with the technical 
documentation referred to in Section 3 of Annex 7. 
8.3 By way of derogation from Section 3, the manufacturer or the 
manufacturer's authorized representative established in the European 
Community undertake to notify the competent authorities of the 
incidents referred to in the abovementioned Section immediately on 
learning of them and to institute and keep updated an appropriate 
internal system for this purpose. 
- 68 -
ANNEX 5 
EC DECLARATION OF CONFORMITY 
(PRODUCTION QUAUTY ASSURANCE) 
1. The manufacturer shall apply the quality system approved for the 
manufacture of the products concerned and carry out the final 
inspection, as specified in Section 3, and shall be subject to the 
EC surveillance referred to in Section 4. 
2. The declaration of conformity is the part of the procedure whereby 
the manufacturer who fulfils the obligations imposed by Section 1 
ensures and declares that the products concerned conform to the type 
described in the EC type-examination certificate and meet the 
provisions of this Directive which apply to them. 
The manufacturer shall affix the CE mark in accordance with 
Article 17 and shall draw up a written declaration of conformity. 
This declaration shall cover a given number of identified specimens 
of the products manufactured and shall be kept by the manufacturer. 
The CE mark shall be accompanied by the identification number of the 
notified body which performs the tasks referred to in this Annex. 
3- Qua Iitv system 
3.1 The manufacturer shall lodge an application for assessment of his 
quality system with a notified body. 
The application shall include: 
the name and address of the manufacturer; 
all the relevant information on the product or product 
category covered by the procedure; 
a written declaration that no application has been lodged with 
any other notified body for the same products-, 
- 69 -
the documentation on the quality system; 
an undertaking to fulfil the obligations imposed by the 
quality system approved; 
an undertaking to keep the approved quality system adequate 
and efficacious; 
where appropriate, the technical documentation on the types 
approved and a copy of the EC type-examination certificates; 
an undertaking by the manufacturer to institute and keep 
updated a post-marketing surveillance system. This 
undertaking shall include an obligation for the manufacturer 
to notify the competent authorities of the following incidents 
immediately on learning of them: 
(i) any deterioration in the characteristics and/or 
performances of a device, as well as any inaccuracies in 
the instruction?leaflet which might lead to or might have 
led to the death of a patient or user or to a serious 
deterioration in their state of health; 
(ii) any technical or medical reason connected with the device 
leading to recall of devices of the same type by the 
manufacturer. 
3.2 Application of the quality system must ensure that the products 
conform to the type described in the EC type-examination 
certificate. AM the elements, requirements and provisions adopted 
by the manufacturer for his quality system shall be documented in a 
systematic and orderly manner in the form of written policies and 
procedures. This quality system documentation must permit uniform 
interpretation of the quality policies and procedures such as 
quality programmes, quality plans, quality manuals and quality 
records. 
- 70 -
It shall include in particular an adequate description of: 
(a) the manufacturer's quality objectives; 
(b) the organization of the business and in particular: 
the organizational structures, the responsibilities of 
the managerial staff and their organizational authority 
where manufacture of the products is concerned; 
the methods of monitoring the efficient operation of the 
quality system and in particular its ability to achieve 
the desired quality of product, including control of 
products which fail to conform; 
(c) the inspection and quality assurance techniques at the 
manufacturing stage and in particular: 
the processes and procedures which will be used, 
particularly as regards sterilization, purchasing and the 
relevant documents; 
the product-identification procedures drawn up and kept 
up to date from drawings, specifications or other 
relevant documents at every stage of manufacture-, 
(d) the appropriate tests and trials 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 shall audit the quality system to determine 
whether it meets the requirements referred to in Section 3.2. It 
shall presume that quality systems which implement the relevant 
harmonized standards conform to these requirements. 
- 71 -
The assessment team shall include at least one member with past 
experience of assessments of the technology concerned. The 
assessment procedure shall include an inspection on the 
manufacturer's premises and, in duly substantiated cases, on the 
premises of the manufacturer's suppliers to inspect the 
manufacturing processes. 
The decision shall be notified to the manufacturer after the final 
inspection. It shall 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 shall assess the changes proposed and shall verify 
whether after these changes the quality system will still meet the 
requirements referred to in Section 3.2. After receiving the 
abovementioned information it shall notify the manufacturer of its 
decision. This decision shall contain the conclusions of the 
inspection and a reasoned assessment. 
4. SurveiI lance 
4.1 The aim of surveillance is to ensure that the manufacturer duly 
fulfils the obligations imposed by the approved quality system. 
4.2 The manufacturer shall authorize the notified body to carry out all 
the necessary inspections and shall 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 manufacture, such as reports concerning inspections, tests, 
calibration and the qualifications of the staff concerned, 
etc. 
- 72 -
4.3 The notified body shall periodically carry out appropriate 
inspections and assessments to make sure that the manufacturer 
applies the approved quality system and shall supply the 
manufacturer with an assessment report. 
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 shall provide the 
manufacturer with an inspection report and, if a test has been 
carried out, with a test report. 
5. Administrative provisions 
5.1 The manufacturer shall, for a period ending at least five years 
after the last product has been manufactured, keep at the disposal 
of the national authorities: 
the declaration of conformity; 
the documentation referred to in the fourth indent of 
Sect ion 3.1 ; 
the changes referred to in Section 3.4; 
the documentation referred to in the seventh indent of 
Sect ion 3.1 -, and 
the decisions and reports from the notified body as referred 
to in Sections 4.3 and 4.4. 
5.2 The notified body shall communicate to the other notified bodies all 
relevant information concerning the quality system approvals issued, 
refused or withdrawn. 
6. Application to devices in Class Ma 
In line with Article 11(2), this Annex may apply to products in 
Class Ma, subject to these derogations: 
- 73 -
6.1 By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the 
declaration of conformity the manufacturer ensures and declares that 
the products in Class Ma are manufactured in conformity with the 
technical documentation referred to in Section 3 of Annex 7 and meet 
the requirements of this Directive which apply to them. 
6.2 By way of derogation from the final indent of Section 3.1, the 
manufacturer shall undertake to notify the competent authorities of 
the incidents referred to in the abovementioned indent immediately 
on learning of them and to institute and keep updated an appropriate 
internal system for this purpose. 
- 74 -
ANNEX 6 
EC DECLARATION OF CONFORMITY 
(PRODUCT QUALITY ASSURANCE) 
1. The manufacturer shall apply the quality system approved for the 
final inspection and testing of the product, as specified in Section 
3, and shall be subject to the surveillance referred to in Section 
4. 
2. The declaration of conformity is the part of the procedure whereby 
the manufacturer who fulfils the obligations imposed by Section 1 
ensures and declares that the products concerned conform to the type 
described in the EC type-examination certificate and meet the 
provisions of this Directive which apply to them. 
The manufacturer shall affix the EC mark in accordance with 
Article 17 and shall draw up a written declaration of conformity. 
This declaration shall cover a given number of identified specimens 
of the products manufactured and shall be kept by the manufacturer. 
The CE mark shall be accompanied by the identification number of the 
notified body which performs the tasks referred to in this Annex. 
3. Qua Iity system 
3.1 The manufacturer shall lodge an application for assessment of his 
quality system with a notified body. 
The application shall include: 
the name and address of the manufacturer; 
all the relevant information on the product or product 
category covered by the procedure-, 
a written declaration that no application has been lodged with 
any other notified body for the same products; 
- 75 -
the documentation on the quality system; 
an undertaking to fulfil the obligations imposed by the 
quality system approved; 
an undertaking to keep the approved quality system adequate 
and efficacious; 
where appropriate, the technical documentation on the types 
approved and a copy of the EC type-examination certificates; 
an undertaking by the manufacturer to notify the competent 
authorities of the following incidents immediately on learning 
of them: 
(i) any deterioration in the characteristics and/or 
performances of a device, as well as any inaccuracies in 
the instruction leaflet which might lead to or might have 
led to the death of a patient or user or to a serious 
deterioration in their state of health; 
(ii) any technical or medical reason connected with the device 
leading to recall of devices of the same type by the 
manufacturer. 
3.2 Under the quality system, each product shall be examined and the 
appropriate tests defined in the relevant standard(s) referred to in 
Article 5 or equivalent tests shall be carried out to ensure that 
the products conform to the type described in the EC 
type-examination certificate and fulfil the provisions of this 
Directive which apply to them. All the elements, requirements and 
provisions adopted by the manufacturer shall be documented in a 
systematic and orderly manner in the form of written measures, 
procedures and instructions. This quality system documentation must 
permit uniform interpretation of the quality programmes, quality 
plans, quality manuals and quality records. 
- 76 -
It shall include in particular an adequate description of: 
the quality objectives and the organizational structure, 
responsibilities and powers of the managerial staff with 
regard to product quality; 
the examinations and tests that will be carried out after 
manufacture; it must be possible to trace back the 
calibration of the test equipment adequately; 
the methods of monitoring the efficient operation of the 
qua Iity system; 
the quality records, such as reports concerning inspections, 
tests, calibration and the qualifications of the staff 
concerned, etc. 
3.3 The notified body shall audit the quality system to determine 
whether it meets the requirements referred to in Section 3.2. It 
shall presume that quality systems which implement the relevant 
harmonized standards conform to these requirements. 
The assessment team shall include at least one member with past 
experience of assessments of the technology concerned. The 
assessment procedure shall include an inspection on the 
manufacturer's premises and, in duly substantiated cases, on the 
premises of the manufacturer's suppliers to inspect the 
manufacturing processes. 
The decision shall be notified to the manufacturer. It shall 
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 shall assess the changes proposed and shall verify 
whether after these changes the quality system will still meet the 
requirements referred to in Section 3.2. After receiving the 
abovementioned information it shall notify the manufacturer of its 
decision. This decision shall contain the conclusions of the 
inspection and a reasoned assessment. 
- 77 -
4. Survelllance 
4.1 The aim of surveillance Is to ensure that the manufacturer duly 
fulfils the obligations imposed by the approved quality system. 
4.2 The manufacturer shall allow the notified body entrance for 
inspection purposes to the inspection, testing and storage locations 
and shall supply it with all relevant information, in particular: 
the documentation on the quality system; 
the technical documentation; 
the quality records, such as reports concerning inspections, 
tests, calibration and the qualifications of the staff 
concerned, etc. 
4.3 The notified body shall periodically carry out appropriate 
inspections and assessments to make sure that the manufacturer 
applies the quality system and shall supply the manufacturer with an 
assessment report. 
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 and that the production 
conforms to the requirements of the Directive which apply to it. To 
this end, an adequate sample of the final products, taken on site by 
the notified body, shall be examined and the appropriate tests 
defined in the relevant standard(s) referred to in Article 5 or 
equivalent tests shall be carried out. Where one or more of the 
samples fails to conform, the notified body shall take the 
appropriate measures. It shall provide the manufacturer with an 
inspection report and, if a test has been carried out, with a test 
report. 
- 78 -
5. Administrative provisions 
5.1 The manufacturer shall, for a period ending at least five years 
after the last product has been manufactured, keep at the disposal 
of the national authorities: 
the declaration of conformity; 
the documentation referred to in the seventh indent of 
Section 3.1 -, 
the changes referred to in Section 3.4; and 
the decisions and reports from the notified body as referred 
to in the final indent of Section 3.4 and in Sections 4.3 and 
4.4. 
5.2 The notified body shall communicate to the other notified bodies all 
relevant information concerning the quality system approvals issued, 
refused or withdrawn. 
6. Application to devices in Class Ma 
In line with Article 11(2), this Annex may apply to products in 
Class Ma, subject to this derogation: 
6.1 By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the 
declaration of conformity the manufacturer ensures and declares that 
the products in Class Ma are manufactured in conformity with the 
technical documentation referred to in Section 3 of Annex 7 and meet 
the requirements of this Directive which apply to them. 
- 79 -
ANNEX 7 
EC DECLARATION OF CONFORMITY 
1. 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 Section 2 and, in 
the case of sterile products and measuring devices, the obligations 
imposed by Section 5 ensures and declares that the products 
concerned meet the provisions of this Directive which apply to them. 
The manufacturer may affix the CE mark to each product in accordance 
with Article 17. The manufacturer shall draw up a written 
declaration of conformity. 
2. The manufacturer shall establish the technical documentation 
described in Section 3. The manufacturer or his authorized 
representative established in the Community shall keep this 
documentation, including the declaration of conformity, at the 
disposal of the national authorities for inspection purposes for a 
period ending at least five years after the last product has been 
manufactured. 
Where neither the manufacturer nor his authorized representative are 
established in the Community, this obligation to keep the technical 
documentation available shall be the responsibility of the person 
who places the product on the Community market. 
3. The technical documentation must allow assessment of the conformity 
of the product with the requirements of the Directive. It shall 
include in particular: 
a general description of the product, including any variants 
planned; 
design drawings, methods of manufacture envisaged and diagrams 
of components, sub-assemblies, circuits, etc.; 
- 80 -
the descriptions and explanations necessary to understand the 
abovementioned drawings and diagrams and the operation of the 
product ; 
a list of the standards referred to in Article 5, applied in 
full or in part, and descriptions of the solutions adopted to 
meet the essential requirements of the Directive if the 
standards referred to in Article 5 have not been applied in 
full ; 
in the case of sterile products, a description of the methods 
used; 
the results of the design calculations and of the inspections 
carried out, etc. if the device is to be connected to other 
device(s) in order to operate as intended, proof must be 
provided that it conforms to the essential requirements when 
connected to any such device(s) having the characteristics 
specified by the manufacturer; 
the test reports and, where appropriate, clinical data. 
4. The manufacturer shall take all the measures necessary for the 
manufacturing process to ensure that the products manufactured 
conform to the technical documentation referred to in Section 3 and 
to the requirements of the Directive which apply to them. 
5. In the case of products placed on the market in sterile condition 
and of measuring devices, the manufacturer must observe not only the 
provisions laid down in this Annex but also one of the procedures 
referred to in Annexes 4, 5 or 6. Application of the abovementioned 
Annexes and the intervention by the notified body shall be limited 
to: 
in the case of sterile products, only the aspects of 
manufacture concerned with obtaining sterile conditions; 
in the case of measuring devices, only the aspects of 
manufacture concerned with the conformity of the products with 
the metrological requirements. 
Section 6.1 of this Annex shall apply. 
- 81 -
6. Application to devices in Class Ma 
In line with Article 11(2), this Annex may apply to products in 
Class Ma, subject to this derogation: 
6.1 Where this Annex is applied in conjunction with the procedure 
referred to in Annex 4, 5 or 6, the declaration of conformity 
referred to in Section 1 of this Annex and the declaration of 
conformity referred to in the other abovementioned Annexes shall 
form a single declaration. As regards the declaration based on this 
Annex, the manufacturer shall ensure and declare that the product 
design meets the provisions of this Directive which apply to it. 
- 82 -
ANNEX 8 
STATEMENT CONCERNING DEVICES 
FOR SPECIAL PURPOSES 
1. For custom-made devices or for devices intended for clinical 
investigations the manufacturer or his authorized representative 
established in the Community shall draw up the statement containing 
the information stipulated in Section 2. 
2. The statement shall contain the following information: 
2.1 For custom-made devices: 
data allowing identification of the device in question; 
a statement that the device is intended for exclusive use by a 
particular patient, together with the name of the patient; 
the name of the medical specialist or other authorized person 
who made out the prescription and, where applicable, the name 
of the clinic concerned; 
the particular features of the device as specified in the 
relevant medical prescription; 
a statement that the device in question conforms to the 
essential requirements set out in Annex 1 and, where 
applicable, indicating which essential requirements have not 
been fully met, together with the grounds. 
2.2 For devices intended for the clinical investigations covered by 
Annex 10: 
data allowing identification of the device in question-, 
an investigation plan stating in particular the purpose, scope 
and number of devices concerned; 
the opinion of the Ethics Committee concerned and details of 
the aspects covered by its opinion-, 
- 83 -
the name of the medical specialist or other authorized person 
and of the institution responsible for the Investigations; 
the place, starting date and scheduled duration for the 
invest igat ions; 
a statement that the device in question conforms to the 
essential requirements apart from the aspects covered by the 
investigations and that, with regard to these aspects, every 
precaution has been taken to protect the health and safety of 
the pat ient. 
3. The manufacturer shall also undertake to keep available for the 
competent national authorities: 
3.1 For custom-made devices, documentation allowing an understanding of 
the design, manufacture and performances of the product, including 
the expected performances, so as to allow assessment of conformity 
with the requirements of this Directive. 
The manufacturer 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. 
3.2 For devices intended for clinical investigations, the documentation 
shalI contain: 
a general description of the product; 
design drawings, methods of manufacture envisaged, in 
particular as regards sterilization, and diagrams of 
components, sub-assemblies, circuits, etc.-, 
the descriptions and explanations necessary to understand the 
abovementioned drawings and diagrams and the operation of the 
product ; 
a list of the standards referred to in Article 5, applied in 
full or in part, and descriptions of the solutions adopted to 
meet the essential requirements of this Directive if the 
standards referred to in Article 5 have not been applied; 
the results of the design calculations, and of the inspections 
and technical tests carried out, etc. 
- 84 -
The manufacturer shall take all the measures necessary for the 
manufacturing process to ensure that the products manufactured 
conform to the documentation referred to In the first paragraph of 
this Sect ion. 
The manufacturer may authorize the assessment, or audit where 
necessary, of the effectiveness of these measures. 
- 85 -
ANNEX 9 
CLASSIFICATION CRITERIA 
I. CLASSIFICATION PUUS 
1. Non-invasive devices 
1.1 Rule 1 
All non-invasive devices are in Class I, unless one of the rules set 
out hereinafter applies. 
1.2 Rule 2 
All non-invasive devices intended for channelling or storing blood, 
body liquids or tissues, liquids or gases for the purpose of 
eventual infusion, administration or introduction into the body are 
in Class lia: 
if they are connected to an active medical device in Class Ma 
or a higher class; 
if they are used for storing blood or other body liquids or 
t i ssues. 
in all other cases they are in Class I. 
1.3 Rule 3 
AM non-invasive devices intended for modifying the biological or 
chemical composition of blood, other body liquids or other liquids 
intended for infusion into the body are in Class lib, unless the 
treatment consists of filtration, centrifugation or exchanges of 
gas, heat or solute, in which case they are in Class Ma. 
- 86 -
1 .4 Rule 4 
All non-invasive devices which come into contact with injured skin 
are in Class I if they are intended to be used as a mechanical 
barrier, for compression, for the absorption of exudates or for 
moisture permeability. 
They are in Class Mb if they are intended to be used principally 
for third-degree burns or other skin injuries of comparable degree. 
In all other cases they are In Class Ma. 
2. Invasive devices 
2.1 Rule 5 
All invasive devices with respect to body orifices, other than 
surgically invasive devices and which are not intended for 
connection to an active medical device: 
are in Class I If they are intended for transient use; 
are in Class Ma if they are intended for short-term use, 
except If they are used in the oral cavity as far as the 
pharynx, in the anterior nostrils or the external ear canal up 
to the ear drum, in which case they are in Class I; 
are in Class Ma if they are intended for long-term use. 
All Invasive devices with respect to body orifices, other than 
surgically invasive devices intended for connection to an 
active medical device in Class Ma or a higher class, are in 
Class Ma. 
2.2 Rule 6 
All surgically invasive devices intended for transient use are in 
Class Ma unless they are: 
- 87 -
intended to diagnose, monitor or correct a defect of the heart 
or of the central circulatory system through direct contact 
with these parts of the body, in which case they are in 
Class 111; 
reusable surgical instruments, in which case they are in 
Class I. 
2.3 Rule 7 
All surgically invasive devices intended for short-term use are in 
Class Ma unless they are intended: 
either to diagnose, monitor or correct a defect of the heart 
or of the central circulatory system through direct contact 
with these parts of the body, in which case they are in 
Class I I I ; 
or for use in direct contact with the central nervous system, 
in which case they are in Class III. 
2.4 Rule 8 
All implantable devices and long-term surgically invasive devices 
are in Class lib unless they are intended: 
to be placed in the teeth, in which case they are in 
CI ass 11 a ; 
to be used in direct contact with the heart, the central 
circulatory system or the central nervous system, in which 
case they are in Class III; 
to undergo chemical change in the body, to be biologically 
active, to be wholly or mainly absorbed, to supply energy in 
the form of ionizing radiation or to administer medicines, in 
which case they are in Class III, except if the devices are 
placed in the teeth. 
- 88 -
3. Act ive devices 
3.1 Rule 9 
All active therapeutical devices intended to supply energy or to 
administer, sample or exchange substances are in Class Ma unless 
they are intended: 
to administer potentially dangerous levels or forms of energy 
to the human body, taking account of the part of the body 
absorbing the energy and/or the density of the energy; 
to administer or exchange medicines, body liquids or other 
substances in a potentially dangerous way, taking account of 
the nature of the substances administered and of the part of 
the body concerned, or in such a way that the exchange or flow 
cannot be controlled by the patient. 
In these cases, the devices are in Class Mb. All active 
devices intended to control and monitor the performance of 
active therapeutical devices in Class I lb or intended directly 
to influence the performance of such devices are in Class Mb. 
3.2 Rule 10 
All active devices intended for diagnosis are in Class Ma: 
if they are intended to supply energy which will be absorbed 
by the human body, except for devices used to illuminate the 
patient's body, in the visible spectrum; 
if they are intended primarily to allow direct diagnosis of 
vital physiological processes in a situation posing an 
immediate danger to the patient's life. 
3.3 Rule 11 
All other active devices are in Class I. 
- 89 -
Special rules 
4.1 Rule 12 
All devices incorporating, as an integral part, a substance which, 
if used separately, can be considered to be a medicinal product, as 
defined in Article 1 of Directive 65/65/EEC, and whose action in 
combination with the devices can result in its bioavailability, are 
in Class III. 
4.2 Rule 13 
All devices used for contraception or the prevention of the 
transmission of a viral disease by sexual contact are in Class Mb. 
- 90 -
II. DEFINITIONS AND IMPLEMENTING RULES 
1. DEFINITIONS FOR THE CLASSIFICATION RULES 
1.1 Pujatlon 
Transient Normally intended for continuous use for less than 60 
minutes. 
Short term Normally intended for continuous use for not more 
than 30 days. 
Long term Normally intended for continuous use for more than 
30 days. 
1.2 Invasive devices 
Invasive device A device which, in whole or in part, penetrates 
inside the body, either through a body orifice or 
through the surface of the body. 
Body orifice Any natural opening in the body, including the 
external surface of the eyeball, or any permanent 
artificial opening, such as a stoma. 
Surgically Invasive 
device A device which penetrates inside the body through 
the surface of the body, with the aid or in the 
context of a surgical operation. 
1-3 Reusable surgical 
instrument Instrument intended for a surgical operation such as 
cutting, drilling, sawing, scratching, retracting or 
clipping without connection to any other medical 
device and which can be used in several different 
operations. 
- 91 -
1.4 Active medical 
device Any medical device connected to or equipped with a 
source of electrical energy or any source of power 
other than that directly generated by the human body 
or gravity and which acts by converting this energy. 
Medical devices intended to transmit energy, 
substances or other elements between an active 
medical device and the patient, without any 
significant change, are not considered to be active 
medical devices. 
1.5 Active therapeutical 
device Any active medical device, whether used alone or in 
combination with other medical devices, to support, 
modify or replace biological functions or structures 
with a view to treatment or alleviation of an 
illness, injury or handicap. 
1-6 Active device for 
d i aonos i s Any active medical device, whether used alone or in 
combination with other medical devices, to supply 
information for detecting, diagnosing, monitoring or 
treating physiological conditions, states of health, 
illnesses or congenital deformities. 
1.7 Central circulatory 
system The following vessels: 
arteriae pulmonales, aorta ascendens, arteriae 
coronariae, arteria carotis communis, arteria 
carotis externa, arteria carotis interna, arteriae 
cerebrates, truncus brachiocephalicus, venae cordis, 
venae pulmonales, vena cava superior, vena cava 
inferior. 
1.8 Central nervous 
system Brain and spinal cord. 
- 92 -
2. IMPLEMENTING RULES 
2.1 Application of the classification rules shall be governed by the 
intended purpose of the devices. 
2.2 if the device is intended to be used in combination with another 
device, the classification rules shall apply separately to each of 
the devices. 
2.3 if the device is not intended to be used solely or principally in a 
specific part of the body, it must be considered and classified on 
the basis of the most critical use. 
2.4 If two rules apply to the same device, based on the performance 
specified for the device by the manufacturer, the rule resulting in 
the higher classification shall apply. 
- 93 -
ANNEX 10 
CLINICAL EVALUATION 
1. General provisions 
1.1 As a general rule, confirmation of conformity with the requirements 
concerning the characteristics and performances referred to in 
Section 1 of Annex 1 under the normal conditions of use of the 
device and the evaluation of the undesirable side-effects must be 
based on clinical data in the case of implantable devices, devices 
in Class III and, where Justified, other devices. Taking account of 
any relevant harmonized standards, where appropriate, the adequacy 
of the clinical data shall be based on: 
1.1.1 either a compilation of the relevant scientific literature currently 
available on the intended purpose of the device and the techniques 
employed as well as, if appropriate, a written report containing a 
critical evaluation of this compilation; 
1.1.2 or the results of all the clinical investigations made, including 
those carried out in conformity with Section 2. 
1.2 All the data must remain confidential, in conformity with the 
provisions of Article 20. 
2. Clinical investigation 
2.1 Objectives 
The objectives of clinical investigation are: 
to verify that, under normal conditions of use, the 
performances of the devices conform to those referred to in 
Section 3 of Annex 1; and 
to determine any undesirable side-effects, under normal 
conditions of use, and assess whether they are risks when 
weighed against the intended performance of the device. 
- 94 -
2.2 Ethical considerations 
Clinical investigations shall be carried out in accordance with the 
Helsinki Declaration adopted by the 18th World Medical Assembly in 
Helsinki, Finland, in 1964, as last amended by the 41st World 
Medical Assembly in Hong Kong in 1989. It is mandatory that all 
measures relating to the protection of human subjects are carried 
out in the spirit of the Helsinki Declaration. This shall include 
every step in the clinical investigation from first consideration of 
the need and Justification of the study to publication of the 
results. 
2.3 Methods 
2.3.1 Clinical investigations shall be performed on the basis of an 
appropriate plan of investigation corresponding to the state of the 
art and defined in such a way as to confirm or refute the 
manufacturer's claims for the device-, these investigations shall 
include an adequate number of observations to guarantee the 
scientific validity of the conclusions. 
2.3.2 The procedures used to perform the investigations shall be 
appropriate to the device under examination. 
2.3.3 Clinical investigations shall be performed in circumstances similar 
to the normal conditions of use of the device. 
2.3.4 All the appropriate features, including those involving the safety 
and performances of the device, and its effect on patients shall be 
examined. 
2.3.5 All adverse incidents shall be fully recorded. 
2.3.6 The Investigations shall be performed under the responsibility of a 
medical specialist or another authorized qualified person in an 
appropriate environment. 
The medical specialist or other authorized person shall have access 
to the technical and clinical data regarding the device. 
- 95 -
2.3.7 The written report, signed by the medical specialist or other 
authorized person responsible, shall contain a critical evaluation 
of all the data collected during the clinical investigation. 
- 96 -
ANNEX 11 
MINIMUM CRITERIA FOR THE DESIGNATION OF 
NOTIFIED INSPECTION BODIES 
1. The notified body, its Director and the assessment and verification 
staff shall not be the designer, manufacturer, supplier, installer 
or user of the devices which they inspect, nor the authorized 
representative of any of these persons. They may not be directly 
involved in the design, construction, marketing or maintenance of 
the devices, nor represent the parties engaged in these activities. 
This in no way precludes the possibility of exchanges of technical 
information between the manufacturer and the body. 
2. The inspection 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 
and, In particular, of this Annex. 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. 
3. The notified body must be able to carry out all the tasks assigned 
to such bodies by one of Annexes 2 to 6 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. 
- 97 -
4. The inspection staff must have: 
sound vocational training covering all the assessment and 
verification operations for which the body has been 
designated; 
satisfactory knowledge of the rules on the inspections which 
they carry out and adequate experience of 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. 
6. The body must take out civil liability insurance, unless liability 
is assumed by the State under the national law 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. 
- 98 -
ANNEX 12 
CE MARK OF CONFORMITY 
- 99 
FICHE FINANCIERE 
VOLET 1 : IMPLICATIONS FINANCIERES 
1. Int itulé de I'act Ion 
Proposition de directive concernant le rapprochement des 
législations des Etats membres relatives aux dispositifs 
méd i eaux . 
2. Lignes budgétaires concernées 
article B 5-300 : actions relatives à l'achèvement du 
Marché Intérieur, dépenses 
opérât ionneII es 
article B 8-530 : actions relatives à l'achèvement du 
Marché Intérieur, dépenses d'appui et de 
sout i en . 
3. Base léga I e 
Article 100A du Traité CEE 
4. Description de l'action 
4.1. Achèvement du Marché Intérieur dans le secteur des 
dispositifs médicaux; amélioration de la protection de 
la santé et de la sécurité des patients et des 
ut i Ii sateurs. 
En suivant les principes de la Nouvelle Approche, la 
directive harmonise les exigences et les procédures 
d'évaluation de conformité auxquelles doivent répondre 
les dispositifs médicaux lors de leur mise sur le marché 
et de leur mise en service. La mise en oeuvre efficace 
implique auprès de la Commission, des Etats membres et 
des organismes européens de normalisation CEN/CENELEC 
des activités dans les domaines suivants -. 
établissement des normes harmonisées par le 
CEN/CENELEC facilitant la preuve de la conformité aux 
exigences essentielles de la directive, 
mise en place par les Etats membres d'une 
infrastructure d'autorités compétentes assurant le 
contrôle du respect de la directive ainsi que la 
désignation par les Etats membres des organismes de 
certification chargés de l'évaluation de la 
conform i té, 
- 100 -
étab I i ssement 
permettant au 
de protect ion 
intervenus av 
éIaborati on p 
utiles à I'a p 
portant sur s 
cIass i f i cat io 
gest i on des p 
des d i spos i t i 
sauvegarde im 
des exper ts , 
mise en pi ace 
portant sur I 
classificatio 
cadre du syst et gestion d'un système d'alerte 
x Etats membres de prendre des mesures 
suite à des incidents indésirables 
ec des d i spos i t i fs, 
ar la Commission des lignes directrices 
plication uniforme de la directive 
on champ d'application ainsi que sur la 
n des d i spos i t i fs, 
rocédures concernant la classification 
fs et l'application de la clause de 
pliquant le recours à l'avis technique 
d'une base européenne de données 
a certification des dispositifs, la 
n et les incidents notifiés dans le 
ème d'alerte. 
4.2. Durée : environ 4-5 ans; action ponctuelle. Le montant 
des crédits alloués pour cette action sera toutefois 
déterminé chaque année en fonction des travaux restant à 
ef fectuer. 
4.3. Population concernée : potentiellement, l'ensemble de la 
population communautaire et des pays tiers. 
Classification des dépenses 
5.1. Dépenses non obligatoires 
5.2. . B5-300 : crédits dissociés 
. B8-530 : crédits non dissociés 
Nature des dépenses 
L'élaboration des normes harmonisées par le CEN/CENELEC est 
couverte par une contribution financière de la Communauté et 
l'AELE (part du financement incombant à la CE .- 86%, à 
l'AELE : 14%). Les frais restant seront couverts par les 
organismes de normalisation et les parties concernées 
(industrie, organismes de certification etc). 
Le financement sera octroyé moyennant des bons de commande 
passés en vertu du contrat-cadre du 4 août 1989 signé avec le 
CEN/CENELEC. 
La mise en place d'une base de données nécessitera un 
financement sous forme d'étude de faisabilité et de prestation 
de services au cours de la phase de démarrage. 
La fourniture des avis techniques nécessaires en vue des 
questions spécifiques dans le cadre de la gestion courante 
sera financée par des contrats d'étude et de prestation de 
service. 
- 101 -
7. Incidence financière sur les crédits d'intervention (partie B 
du budget) 
a) élaboration des normes européennes (CD) 
1. Mode de calcul 
Le financement sera déterminé en fonction des travaux à 
confier aux contractants. Il sera calculé sur la base de 
l'unité "homme/mois", qui s'élève actuellement à 
8.000 ECU. 
Le nombre de normes harmonisées nécessaires jusqu'à fin 
1996 est de 300. La contribution de la Commission est 
estimée à 6,25 hommes/mois par norme; 
Frais totaux : 1.875 hommes/mois, soit 15 mio ECU 
2. L'échéancier indicatif des crédits pourrait être le 
su i vant : 
1992 
1993 
1994 
1995 
1996 Crédits d'engagement 
(1.000 ECU) 
1 .500 
4.000 
5.000 
4.500 
p.m. Crédits de pa i ement 
(1.000 ECU) 
1 .000 
2.000 
4.000 
5.000 
3.000 
15.000 15.000 
Le niveau des crédits à partir de 1992 sera fixé par la 
procédure budgétaire annuelle dans le cadre des 
contraintes fixées par les Perspectives financières 
post 92. 
Pour 1992, le montant global (mini-budgets compris) est 
inclus dans le chiffre total des dépenses de -
Notification, reconnaissance mutuelle, harmonisation des 
législations techniques, normalisation et rectification 
et essais (33.153.000) de la fiche financière globale 
des postes B5-300 et B8-530. 
b) autres mesures financées par le mini-budget 
conformément à la décision de la Commission du 22.5.1990 
sur les mini-budgets 
frais d'experts : 450 à 500 ECU par expert, par Jour 
ECU 
1992 
1993 
1994 
1995 
1996 30 x 450 ECU 
30 X 450 ECU 
30 x 450 ECU 
20 x 500 ECU 
20 x 500 ECU 
TOTAL (1992-1996) 13 
13 
13 
10 
10 500 
500 
500 
000 
000 
60.500 
- 102 -
frais pour la mise en place et le démarrage de la base 
de données, à répartir en trois tranches sur les années 
1992 à 1994 : 
ECU 
* 1992 
* 1993 
* 1994 
TOTAL (1992-1994) 200.000 
200.000 
100.000 
500.000 
8. Dispositions anti-fraude prévues dans la proposition d'action? 
Le contrat-cadre visé sous le point 6. prévoit un 
échelonnement des paiements en fonction des progrès des 
travaux, ainsi que la possibilité d'un audit par la Commission 
ou la Cour des Comptes. 
VOLET 2 : DEPENSES ADM INSTRATIVES (partie A du budget) 
L'action proposée implique une augmentation du personnel statutaire 
affecté à la gestion de la directive. Les procédures décisionnelles 
portant sur la classification des dispositifs et sur la clause de 
sauvegarde, le suivi de la normalisation européenne présupposent 
l'existence d'effectifs pouvant établir des analyses et avis 
technico-Juridiques et en organiser la gestion administrative. 
Les besoins en personnel sont à pourvoir, soit par voie de 
redéploiement interne, soit par décision de la Commission 
allocation ressources dans le cadre de la procédure budgétaire, 
sont estimés, pour l'unité III.D.4, à partir de 1992 à : I Is 
- 1 A 
- 1 B 
soit environ 200.000 ECU, à raison de 100.000 ECU en moyenne par 
personne et par an. 
VOLET 3 : ELEMENTS D'ANALYSE COUT-EFFICACITE 
1. Objectifs et cohérence avec ia programmation financière 
La directive de type Nouvelle Approche s'inscrit dans le cadre 
de l'achèvement du Marché Intérieur. Le renvoi aux normes 
harmonisées fait partie de l'action pluriannuelle de la 
Commission qui consiste à soutenir le renforcement et 
l'élargissement de la normalisation européenne. 
L'action est prévue dans la programmation financière de la 
DG III. 
- 103 -
2. Justification de l'action 
Les divergences dans les systèmes nationaux en ce qui concerne 
les exigences pour les produits et les procédures relatives à 
la mise sur le marché entraînent un gaspillage énorme de 
ressources humaines et financières à charge des fabricants et 
des Etats membres. 
Les procédures communautaires permettront d'éviter la 
répétition multiple des procédures visant le même objet. De 
plus, les exigences harmonisées permettront à l'industrie de 
réaliser des économies sur le prix par unité de production, ce 
qui pourra même avoir un effet bénéfique sur les dépenses à 
charge des systèmes de santé publique. 
Quant à l'harmonisation des normes, l'action vise à mettre en 
commun les ressources et, de ce fait, à éviter la 
multiplication des dépenses pour l'ensemble des Etats membres. 
Globalement, les ressources requises à imposer au budget 
communautaire ne représentent qu'une part mineure par rapport 
à la totalité des ressources qui, de la part des Etats membres 
et des parties concernées, seront allouées dans la suite de 
l'action au bénéfice commun. 
3. Suivi et évaluation de l'action 
3.1. Indication des performances : 
degré d'harmonisation au plan de la normalisation 
(nombre de normes), 
nombre de certifications effectuées, 
nombre de rapports notifiés sur des incidents 
i ndés i rabI es , 
nombre de procédures de clause de sauvegarde. 
3.2. Modalités des évaluations : 
rapports d'état des progrès périodiques sur la 
normalisation dans le cadre de la directive du 
Conseil 83/189/CEE ayant au minimum un caractère 
annue I ; 
échanges de vues dans un Comité sectoriel 
"dispositifs médicaux". 
3.3. Principaux facteurs d'incertitude : 
la désignation des organismes de certification par 
les Etats membres se fait sur une base facultative et 
de manière décentralisée, 
l'assurance d'une application homogène d'un tel 
système présuppose, aussi bien auprès des Etats 
membres que sur le plan communautaire, la 
disponibilité d'interfaces assurant le fonctionnement 
des procédures. 
- 104 -
Fiche d'évaluation d'impact 
Impact de la proposition sur les entreprises et, en 
particulier, sur les petites et moyennes entreprises 
TITRE DE LA PROPOSITION 
Proposition de directive concernant le rapprochement des 
législations des Etats membres relatives aux dispositifs 
méd i eaux. 
NUMERO DE REFERENCE DU DOCUMENT 
2121.21 
LA PROPOSITION 
.1. Compte tenu du principe de subsidiarité , pourquoi une 
législation conmunautai re est-elle nécessaire dans ce 
domaine et quels sont ses principaux objectifs? 
Les réglementations nationales relatives à la mise sur le 
marché et la mise en service des dispositifs médicaux 
présentent un tel degré de divergences substantielles, 
qu'une libre circulation dans la Communauté n'est pas 
assurée. L'harmonisation des exigences et des procédures 
d'évaluation de la conformité auxquelles doivent répondre 
les dispositifs médicaux pour assurer la protection des 
patients, utilisateurs et tiers est, dès lors, le seul moyen 
pour achever le marché intérieur dans ce secteur. 
IMPACT SUR LES ENTREPRISES 
2. Qui sera affecté par la proposition? 
secteurs d'entreprises : tout fabricant de dispositifs 
médicaux (à l'exception des dispositifs implantables 
actifs, tels que des stimulateurs cardiaques ainsi que 
des dispositifs destinés au diagnostic in-vitro), 
exemples : appareils électromédicaux, produits à usage 
unique, matériaux et prothèses dentaires, prothèses 
orthopédiques, instruments, etc 
tailles des entreprises : toute taille, y compris les 
multinationales et le.s PME 
zones géographiques particulières d'implantation : aucune 
- 105 -
Quelles mesures les entreprises devront-e I I es prendre pour 
se conformer à la proposition? 
A partir de l'application totale de la directive, c'est-à-
dire le 1er Juillet 1997 : 
la conception et la fabrication des produits devront 
répondre aux exigences de la directive, 
les fabricants ou leurs mandataires devront suivre les 
procédures d'évaluation de conformité prévues. 
Au cours d'une période de trois ans à partir de la première 
application de la directive (entre Juin 1994 et Juin 1997), 
les fabricants pourront, soit continuer à appliquer les 
législations nationales préexistantes, soit se conformer au 
rég ime harmon i se. 
Quant aux procédures d'évaluation de conformité, les 
fabricants pourront choisir, en cas d'intervention d'une 
tierce partie, entre trois ou quatre procédures 
alternativement applicables. 
Les dispositions transitoires ainsi que le choix pour les 
fabricants entre plusieurs procédures d'évaluation de la 
conformité devront faciliter la transition vers le régime 
harmon i se. 
Quels effets économiques 
d'avoir? a proposition est-elle susceptible 
sur I'emplo i : aucun effet significatif n'est escompté. 
sur les investissements et la création de nouvelles 
ent repri ses : la directive peut avoir comme effet, 
notamment en ce qui concerne les dispositifs médicaux 
présentant un risque élevé, qu'une partie des entreprises 
doivent adapter leurs procédés de fabrication, de sorte à 
permettre une qualité de production élevée et constante. 
Or, ces investissements renforceront la compétitivité des 
ent repr i ses. 
sur la compétitivité des entreprises : l'action proposée 
facilitera l'accès à un marché de dimension 
communautaire. Cette perspective ouvrira de nouveaux 
horizons aux entreprises de taille plus modeste qui ne 
disposent pas de filiales dans chaque Etat membre pour 
traiter directement avec les autorités nationales 
compétentes. Il faut également souligner que les 
entreprises devront, de ce fait, faire face à une 
intensification de la concurrence. 
La proposition contient-elle des mesures visant à tenir 
compte de la situation spécifique des petites et moyennes 
entrepr ises? 
Non 
- 106 -
CONSULTATION 
Pour préparer cette proposition, la Commission a organisé, depuis 
1989, au moins cinq réunions rassemblant les experts 
gouvernementaux et les fédérations professionnelles. De plus, de 
multiples réunions bilatérales avec les fédérations sur des 
aspects spécifiques ont eu lieu. 
Ont été consultées : 
les associations européennes de l'industrie des dispositifs 
méd i eaux , 
les associations des utilisateurs, notamment des médecins et 
des pharmaciens. 
La Commission a, dans une large mesure, tenu compte des 
commentaires reçus lors de la consultation. Les milieux 
intéressés, y compris les fédérations industrielles, ont 
principalement supporté l'approche suivie dans la proposition. 
ISSN 0254-1475 
COM(91) 287 final 
DOCUMENTS 
EN 06 
Catalogue number : CB-CO-91-356-EN-C 
ISBN 92-77-74963-6 
Office for Official Publications of the European Communities 
Lr29SS Luxembourg