No C 14/4 Official Journal of the European Communities 18. 1. 89 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the approximation of the laws of the Member States 
relating to active implantable electromedical equipment 
COM(88) 717 final — SYN 173 
(Submitted by the Commission on 22 December 1988) 
(89/C 14/05) 
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 Parliament. 
Having regard to the opinion of the Economic and 
Social Committee. 
Whereas, in each Member State, active implantable elec­
tromedical devices used in human medicine must meet a 
high and clearly-defined level of safety both for the users 
of such equipment and for those receiving treatment by 
means of the equipment; 
Whereas several Member States have sought to ensure 
that level of safety by mandatory specifications relating 
both to the technical safety regulations and the 
inspection procedures; whereas those specifications differ 
from one Member State to another; 
Whereas the national provision ensuring such safety level 
should be harmonized in order to guarantee the free 
market of active implantable electromedical devices 
without lowering existing and justified levels of safety in 
the Member States; 
Whereas the regulations for active implantable electro­
medical devices can be confined to those provisions 
needed to satisfy the essential safety requirements: 
whereas because they are essential these requirements 
must replace corresponding national provisions; Whereas, inspection procedures have to be provided, 
established on the basis of mutual acceptance by the 
Member States in conformity with Community criteria, 
HAS ADOPTED THIS DIRECTIVE: 
CHAPTER I 
Article 1 
1. This Directive applies to active implantable electro­
medical devices. 
2. For the purpose of this Directive the following defi­
nitions shall apply: 
— medical device: any instrument, apparatus, implement, 
substance or other article (used singly or in combi­
nation) which is intended by the manufacturer for 
use in humans for: 
(a) contraception; 
(b) diagnosis, prevention, monitoring, treatment or 
alleviation of disease or injury; 
(c) investigation or modification of the anatomy or 
of a physiological process; 
which does not achieve its principal intended action 
by pharmacological means. 
Software packages which do not form part of an 
instrument, apparatus, implement or article are 
excluded from this definition, 
— active implantable electromedical device: any medical 
device which is intended to be permanently implanted 
within the human body by a surgical operation, such 
a device using electricity from an implanted battery 
or an external source of power, together with 
non-interchangeable accessories (such as pro­
grammers, external power sources) and operating 
software, 
— permanently implanted: implantation within the 
human body for purposes other than for short-term 
purposes. 
18. 1. 89 Official Journal of the European Communities No C 14/5 
Article 2 
Member States shall take all necessary steps to ensure 
that devices referred to in Article 1 (1), hereinafter 
referred to as 'devices', may be placed on the market and 
implanted only if they do not impair patients' safety, 
when properly implanted, maintained and used 
according to their intended purposes. 
Article 3 
The devices referred to in Article 1 (1) shall satisfy the 
essential safety requirements set out in Annex 1. 
Article 4 
1. Member States shall not impede the placing on the 
market, the free circulation and the implantation of 
devices bearing the CE mark. 
2. Member States shall not impede the placing on the 
market and the implantation of devices not bearing the 
CE mark that are: 
— intended for clinical evaluation according to the 
procedure of Article 8 (4), 
— of a prototype nature intended for research and 
safety and effectiveness testing. 
3. From the date of notification of this Directive, 
devices may continue, on a transitional basis for a period 
of three years/ to be placed on the market subject to 
national provisions already in force on that date, 
provided that any such provisions are compatible with 
the requirements of the Treaty. 
Article 5 
1. Member States shall presume compliance with the 
essential safety requirements referred to in Annex 1 in 
respect of devices which are in conformity with: 
(a) the relevant national standards implementing 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 such national standards; 
or with 
(b) the relevant national standards referred to in 
paragraph 2 in so far as, in the areas covered by such 
standards, no relevant harmonized standard exists. 2. Member States shall communicate to the 
Commission the texts of their national standards, as 
referred to in paragraph 1 (b), which they regard as 
complying with the essential safety requirements referred 
to in Annex 1. The Commission shall forward such texts 
forthwith to the Member States. In accordance with the 
procedure provided for in Article 6 (2), it shall notify the 
Member States of those national standards in respect of 
which there is a presumption of conformity with the 
essential safety requirements referred to in Annex 1. 
Member States shall publish the reference numbers of 
those standards. The Commission shall also publish them 
in the Official Journal of the European Community. 
Article 6 
1. Where a Member State or the Commission 
considers that the harmonized standards referred to in 
Article 5 (1) do not entirely meet the essential safety 
requirements referred to in Article 3, the Commission or 
the Member State concerned shall bring the matter 
before the Standing Committee set up under Directive 
83/189/EEC, hereinafter referred to as 'the committee', 
giving the reasons therefor. The committee shall deliver 
an opinion without delay. 
In the light of the committee's opinion, the Commission 
shall inform the Member States whether or not it is 
necessary to withdraw those standards from the publi­
cations referred to in Article 5 (1) (a). 
2. On receipt of the communication referred to in 
Article 5 (2), the Commission shall consult the 
committee. After the committee has given its opinion the 
Commission shall, within a given period, notify the 
Member States whether the national standard in question 
should or should not enjoy presumption of conformity 
and, if so, be subject to national publication of its 
references. 
If the Commission or a Member State considers that a 
national standard no longer fulfils the conditions for 
presumption of conformity to the safety requirements, 
the Commission shall consult the committee. In the light 
of the opinion of the committee, it shall notify the 
Member States whether or not the standard in question 
should continue to enjoy presumption of conformity and 
in the latter case be withdrawn from the publications 
referred to in Article 5 (2). 
Article 7 
1. Where a Member State finds that devices bearing 
the CE mark do not satisfy the essential safety 
requirements when properly implanted and used in 
accordance with their intended purpose, it shall take all 
appropriate measures to withdraw those products from 
the market or to prohibit or restrict their being placed on 
the market. 
No C 14/6 Official Journal of the European Communities 18. 1. 89 
The Member State concerned shall immediately inform 
the Commission of any such measure, indicating the 
reasons for its decision, and in particular whether non 
compliance is due to: 
(a) failure to meet the essential safety requirements 
referred to in Article 3, where the device does not 
meet the standards referred to in Article 5(1); 
(b) incorrect application of the standards referred to in 
Article 5 (1); 
(c) shortcomings in the standards referred to in Article 5 
(1) themselves. 
2. The Commission shall enter into consultation with 
the parties concerned as soon as possible. Where, after 
such consultation, the Commission finds that any 
measure as referred to in paragraph 1 is justified, it shall 
immediately so inform the Member State that took the 
action and the other Member States. Where the decision 
referred to in paragraph 1 is attributed to shortcomings 
in the standards the Commission, after consulting the 
parties concerned, shall bring the matter before the 
Committee within two months if the Member State 
which has taken the measures intends to maintain them 
and shall initiate the procedures referred to in Article 6. 
3. Where a device which does not comply bears the 
CE mark the competent Member State shall take appro­
priate 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. 
CHAPTER II 
Conformity assessment 
Article 8 
1. Devices shall be subject to the EC type examination 
as described in Annex 2, section 2. 
2. After having complied with paragraph 1, the manu­
facturer, or his authorized representative established 
within the Community, to be allowed to affix the CE 
mark on his devices shall, at his own choice, either: 
(a) apply for EC declaration of production conformity 
as described in Annex 2, section 4; or 
(b) apply for EC declaration of production conformity 
as described in Annex 2, section 3. 3. Devices that are made according to standards 
referred to in Article 5 (1) can be subject, as an alter­
native to the provisions of paragraphs 1 and 2 and at 
manufacturer's choice, to the EC declaration of design 
conformity as described in Annex 2, section 1. 
Such a declaration being integrated by the EC 
declaration of production conformity as described in 
Annex 2, section 4. 
4. Standards referred to in Article 5 (1) are of two 
different types: technical and clinical; for the latter, 
waiting for the production of a harmonized standard, 
devices shall be evaluated clinically according to the 
provisions of Annex 5. 
5. The records and correspondence relating to the 
procedures referred to in paragraphs 1, 2 and 3 shall be 
in an official language of the Member State where the 
said procedures will be carried out, or in a language 
acceptable to the notified body. 
Article 9 
1. Member States shall notify to the other Member 
States and the Commission the bodies which they have 
designated for carrying out tasks pertaining to the 
procedures referred to in Article 8, the specific tasks for 
which each body has been designated, and the identifi­
cation codes of the designated bodies. 
The Commission shall publish the list of these notified 
bodies, together with the tasks for which they have been 
designated, in the Official Journal of the European 
Communities and shall ensure that the list is kept up to 
date. 
2. Member States shall apply the minimum criteria, set 
out in Annex 4, for the designation of bodies. Bodies 
that satisfy the criteria fixed by the relevant harmonized 
standards shall be presumed to satisfy the criteria set out 
in Annex 4. 
3. A Member State that has designated a body shall 
annul the designation if the body no longer meets the 
criteria for designation referred to in paragraph 2. It 
shall immediately inform the other Member States and 
the Commission accordingly and withdraw the notifi­
cation. 
CHAPTER III 
CE mark of conformity and inscriptions 
Article 10 
1. The CE mark of conformity as referred to in 
Annex 3 shall be affixed to the device where practicable 
or on the package or on the accompanying documents in 
a clearly visible, easily legible and indelible form. 
18. 1. 89 Official Journal of the European Communities No C 14/7 
2. The affixing of marks which are likely to be 
confused with the CE mark of conformity shall be 
prohibited. 
Article 11 
Where it is established that the CE mark has been 
wrongly affixed to devices because: 
— they do not conform to the relevant standards 
referred to in Article 5(1), 
— they do not conform to an approved type, 
they conform to an approved type which does not 
meet the essential requirements applicable to it, 
the manufacturer has failed to fulfil his obligations 
under the relevant EC declaration of production 
conformity, 
the inspection body shall withdraw the EC design 
approval certificate or the EC quality systems approval 
certificate. CHAPTER IV 
Article 12 
Any decision taken pursuant to this Directive and 
resulting in restrictions on the placing on the market 
and/or taking into service of a device shall state the 
exact grounds on which it is based. Such decision 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 laws in force in the Member 
State in question and of the time limits to which such 
remedies are subject. 
Article 13 
1. Before 1 July 1991, Member States shall adopt and 
publish the laws, regulations and administrative 
provisions necessary in order to comply with this 
Directive. They shall forthwith inform the Commission 
thereof. 
They shall apply such provisions from 1 January 1992. 
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 Directive. 
Article 14 
This Directive is addressed to the Member States. 
ANNEX 1 
ESSENTIAL SAFETY REQUIREMENTS FOR ACTIVE IMPLANTABLE ELECTROMEDICAL 
DEVICES 
1. Sterility 
Patients shall be adequately protected against the risks caused by the use of non-sterile products. 
2. Clinical evaluation 
2.1. The clinical conditions of the patient shall not be worsened by the implantation of the device. 
2.2. Side effects or any undesirable conditions introduced by the device shall not outweight its positive 
effect. 
3. Technical evaluation 
3.1. Protection against misuse 
The function of such devices shall be laid down in the instructions for use and on the labelling in 
order to ensure: 
3.1.1. That physicians are fully aware of the potential and limitations of such devices. 
3.1.2. That physicians have sufficient information to make a correct decision about utilization of the 
device. 
3.1.3. That product parameters and packaging information shall be given in such a way that misinterpre­
tations are minimized. 
No C 14/8 Official Journal of the European Communities 18. 1. 89 
3.2. Protections against hazards arising from the device 
Measures of a technical nature shall be taken in order to ensure: 
3.2.1. That patients are adequately protected against risk of physical injury which might be caused by 
product design such as physical and dimensional features together with the biological characteristics 
of the materials used. 
3.2.2. That patients are adequately protected against power supply depletion by means of a manufacturer's 
statement with respect to the end of life criteria. 
3.2.3. That patients are adequately protected against the hazards related to the use of electricity such as: 
(a) poor insulation; 
(b) excessive leakage currents for the intended use; 
(c) poor protection of electrical circuits from the risk of contacts with body fluids; 
(d) excess heat generated by the device; 
3.2.4. Protection against hazards caused by the impossibility of carrying on systematic maintenance and 
calibration such as: 
(a) significant deterioration in performance features; 
(b) excessive increase of leakage currents; 
(c) degradation of the materials used; 
(d) ingress of body fluids or leakage of containers; 
(e) excessive increase of device-generated heat; 
3.2.5. Protection against hazards which might be caused by environmental influences 
(a) The device shall be designed and manufactured in such a way that mechanical stress which may 
occur during normal use will not irreversibly degrade its safety; 
(b) the device shall be manufactured and packed in such a way that it can resist, within the limits 
set by the manufacturer, to the environment conditions variations (temperature, humidity) that 
could occur either in normal use and during transport and storage, in such a way that its 
performance will not be irreversibly degraded, to such a degree that patient's safety is 
jeopardized; 
(c) measures shall be adopted in order to reasonably protect the patient in which the device has 
been implanted, from the hazards arising from electromagnetic fields or from external electrical 
influences (defibrillators, high frequence surgical equipment, etc.). 
ANNEX 2 
CONFORMITY ASSESSMENT PROCEDURE 
1. EC declaration of design conformity 
1.1. The EC declaration of design conformity is the process whereby the manufacturer who satisfies the 
obligations of paragraph 1.2 declares that the design of the type concerned satisfies the requirements 
of the directive that apply to it. 
1.2. Obligations 
1.2.1. The manufacturer shall have adequately implemented a quality system for design control that will 
ensure that design output will meet approved design requirements, and is subject to EC surveillance 
as specified in paragraph 1.5. 
18. 1. 89 Official Journal of the European Communities No C 14/9 
1.2.2. The manufacturer shall make only once the application for the whole quality system covering the 
provisions of this section and those of section 4 of this Annex, with the exceptions of the provisions 
of paragraph 1.4, and when new technologies are introduced in the production process, together 
with a new product. 
1.3. Quality system 
1.3.1. The manufacturer shall lodge an application for approval of his quality system with a notified body. 
The application shall include 
— the quality system's documentation and all other relevant information, 
— an undertaking to carry out the obligations arising from the quality system as approved, 
— an undertaking to maintain the approved quality system to ensure its continuing suitability and 
effectiveness. 
1.3.2. All the elements, requirements and provisions adopted by the manufacturer shall be documented in 
a systematic and orderly manner in the form of written policies, procedures and instructions. This 
quality system documentation shall ensure a commom understanding of the quality policies and 
procedures such as quality programmes, plans, manuals, and records. 
It shall contain in particular and adequate description of: 
— the quality objectives, and the organizational structure and responsibilities of management and 
their powers with regard to design quality, 
— that design control techniques, processes, and systematic actions that will be used, 
— the design verification techniques, processes, and systematic actions that will be used, and the 
frequency with which they will be used, 
— the means to monitor the achievement of the required design quality and the effective operation 
of the quality system. 
1.3.3. The notified body shall examine and evaluate the quality system to determine whether it satisfies the 
requirements referred to in paragraph 1.3.2. It shall presume compliance with these requirements in 
respect of quality systems that implement the design elements of the corresponding harmonized 
standard. 
The notified body shall notify its decision to the manufacturer and inform the other notified bodies 
thereof. The notification to the manufacturer shall contain the conclusions of the examination and 
the reasoned assessment decision. 
1.3.4. The manufacturer or his authorized representative established in the Community shall keep the 
notified body that has approved the quality system informed of any updating of the quality system 
in relation to changes brought about by, for example, new design technologies and quality concepts. 
1.3.5. A notified body that withdraws approval of a quality system shall so inform the other notified 
bodies, giving the reasons for the decision. 
1.4. Design requirements 
The manufacturer shall establish the design requirements of the type on the basis of the 
requirements of the directive that apply to it, and submit those to the notified body. 
No C 14/10 Official Journal of the European Communities 18. 1. 89 
The notified body shall examine and evaluate the design requirements to determine whether they 
satisfy the relevant requirements of this Directive. It shall notify its decision to the manufacturer and 
inform the other notified bodies thereof. The notification to the manufacturer shall contain the 
conclusions of the examination and the reasoned assessment decision. 
The notified body shall also verify whether the clinical tests have been carried out according to the 
provisions of Article 8 (4). 
1.5. EC surveillance 
1.5.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations 
arising out of the approved quality system. 
1.5.2. The manufacturer shall, upon request, provide all necessary information to the notified body, in 
particular: 
— the quality system documentation, 
— the approved design requirements, 
— the up to date quality records as foreseen by the quality system, such as results of analyses, 
calculations, tests, etc. 
1.5.3. The notified body shall make sure that the manufacturer maintains and applies the quality system. 
It shall provide a surveillance report to the manufacturer. 
2. EC type examination 
2.1. The EC type examination is that part of the procedure by which a notified body ascertains and 
certifies that a product, representative of the production envisaged, meets the provisions of the 
directive that apply to it. 
2.2. The application for the type examination shall be lodged by the manufacturer or his authorized 
representative established within the Community with a single notified body. 
The application shall include: 
— the name and address of the manufacturer and, if the application is lodged by the authorized 
representative, his name and address in addition, 
— a written declaration that the application has not been lodged with any other notified body, 
— the design documentation, as described in paragraph 2.3. 
The applicant shall place at the disposal of the notified body a product, representative of the 
production envisaged hereinafter called 'type'. The notified body may request further samples of the 
type if needed by the test programme. 
A type may additionally cover product variants provided that any modification does not affect the 
level of safety and other performance requirements of the type. 
2.3. The design documentation shall contain so far as relevant for assessment: 
— a general description of the type, 
— conceptual designs and manufacturing drawings and schemes of components, sub-assemblies, 
circuits, etc., 
— descriptions and explanations necessary for the understanding of the above including the 
operation of the products, 
— 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 where the standards referred to in Article 5 
have not been applied, 
— results of design calculations made and of examinations etc., 
— test reports, 
— a report on clinical tests according to the provisions of Article 8 (4). 
18. 1. 89 Official Journal of the European Communities No C 14/11 
2.4. The notified body shall: 
2.4.1. examine the design document and verify that the type has been manufactured in conformity with 
the design documentation and identify the elements which have been designed in accordance with 
the relevant provisions of the standard and the essential requirements of the directive: 
2.4.2. perform or have performed the appropriate examination and/or tests to check whether the solutions 
adopted by the manufacturer meet the essential requirements where the standards referred to in 
Article 5 have not been applied; 
2.4.3. perform or have performed the appropriate examinations and/or tests to check whether the relevant 
standards were effectively applied where the manufacturer has chosen to do so thereby assuring 
conformity with the essential requirements; 
2.4.4. agree with the applicant the location where the examination and/or tests shall be carried out. 
2.5. Where the type meets the provisions of the directive the notified body shall issue an EC type 
approval certificate to the applicant. The certificate shall contain the conclusions of the exam­
ination, conditions (if any) for its validity, and the necessary data for identification of the approved 
type and if relevant description of its functioning. The relevant technical elements such as drawings 
and schemes shall be annexed to the certificate. 
2.6. The other notified bodies shall be informed forthwith of the issuing of the EC type approval 
certificate and its additions referred to in 2.8.2 on the said type. They may obtain a copy of the EC 
type approval certificate and its additions and on a reasoned request may obtain a copy of the 
Annexes to the certificate and the reports on the examinations and tests carried out. 
2.7. A notified body that refuses to issue or withdraws an EC type approval certificate shall so inform 
the Member State which notified this body and the other notified bodies giving the reasons for the 
decision. 
2.8.1. The applicant shall keep the notified body that has issued the EC type approval certificate informed 
of any modification to the approved type. 
2.8.2. Modifications to the approved type must receive additional approval from the notified body that 
issued the EC type approval certificate where such changes affect the safety of patients when 
properly implanted, maintained and used according to their intended purpose. This additional 
approval is given in the form of an addition to the original EC type approval certificate. 
3. EC declaration of production conformity (type 1) 
3.1. The EC declaration of production conformity (type 1) is that part of the procedure whereby the 
manufacturer declares that the products concerned are in conformity with the type as described in 
the EC type approval certificate and satisfy the requirements of this directive that apply to them. 
The manufacturer shall affix the CE mark to each product and draw up a written declaration of 
conformity. The CE mark shall be accompanied by the identification symbol of the notified body 
responsible for the random checks set out in paragraph 3.3. 
3.2. The manufacturer shall take all measures necessary in order that the manufacturing process 
including final product inspection and testing shall ensure homogeneity of production and 
compliance of the products with the type as described in the EC type approval certificate and with 
the requirements of the directive that apply to them. A notified body, chosen by the manufacturer, 
shall carry out random checks on products as set out in either paragraph 3.3. (a) or 3.3. (b) below. 
3.3. (a) The products shall be subject to statistical control where applicable and shall therefore be 
grouped into identifiable lots consisting of units of a single model and manufactured under 
essentially the same conditions. A sample is to be drawn and inspected to determine conformity 
with the acceptability criteria. The operating characteristics are specified below. In those cases 
where a batch is rejected the notified body shall take the appropriate measures to prevent the 
putting on the market of that batch. 
No C 14/12 Official Journal of the European Communities 18. 1. 89 
(b) On site product checks shall be undertaken at random intervals of one year or less. A sample of 
the product shall be examined and appropriate tests as set out in the relevant standard(s) 
referred to in Article 5 or equivalent tests shall be carried out in order to ensure their 
conformity with the relevant requirements of the directive. In those cases where one of the 
products under examination does not conform, the notified body shall take measures appro­
priate to the nature of the defect(s). 
4. EC declaration of production conformity (type 2) 
4.1. The EC declaration of production conformity (type 2) is the procedure whereby the manufacturer 
who satisfies the obligations of paragraph 2 declares that the products concerned are in conformity 
with the type as described in the EC type approval certificate and satisfy the requirements of this 
Directive that apply to them. The manufacturer shall affix the CE mark to each product and draw 
up a written declaration of conformity. The CE mark shall be accompanied by the identification 
symbol of the notified body responsible for EEC surveillance. 
4.2.1. The manufacturer shall have adequately implemented a quality system that will ensure compliance 
of the products with the type as described in the EC type approval certificate or in the EC 
declaration of design conformity and with the requirement(s) of this directive that apply to them. 
The manufacturer is subject to EC surveillance as specified in section 4, paragraph 4. 
4.2.2. The manufacturer shall make only once the application for the quality system mentioned in this 
section, with the exception of the case when new technologies are introduced in the production 
process in view of a new product. 
4.3. Quality system 
4.3.1. The manufacturer shall lodge an application for approval of his quality system with a notified body 
The application shall include: 
— all relevant information, in particular the quality system's documentation and the design docu­
mentation of the approved type, 
— an undertaking to carry out the obligations arising from the quality system as approved, 
— an undertaking to maintain the approved quality system to ensure its continuing suitability and 
effectiveness. 
4.3.2. All the elements, requirements and provisions adopted by the manufacturer shall be documented in 
a systematic and orderly manner in the form of written policies, procedures and instructions. This 
quality system documentation shall ensure a common understanding of the quality programmes, 
plans, manuals, and records. 
It shall contain in particular an adequate description of: 
— the quality objectives, and the organizational structure and responsibilities of management and 
of their powers with regard to product quality, 
— the manufacturing processes, quality control and quality assurance, techniques and systematic 
actions that will be used, 
— the examinations and tests that will be carried out before, during and after manufacture, and the 
frequency with which they will be carried out, 
— the means to monitor the achievement of the required product quality and the effective 
operation of the quality system. 
4.3.3. The notified body shall examine and evaluate the quality system to determine whether is satisfies the 
requirements referred to in section 3, paragraph 2. It shall presume conformity with these 
requirements in respect of quality systems that implement the corresponding harmonized standard. 
It shall notify its decision to the manufacturer and inform the other notified bodies thereof. The 
notification to the manufacturer shall contain the conclusions of the examination and the reasoned 
assessment decision. 
4.3.4. The manufacturer or his authorized representative shall keep the notified body that has approved 
the quality system informed of any updating of the quality system in relation to changes brought 
about by, for example, new technologies and quality concepts. 
18. 1. 89 Official Journal of the European Communities No C 14/13 
4.3.5. A notified body that withdraws approval of a quality system shall so inform the other notified 
bodies, giving the reasons for the decision. 
4.4. EC surveillance 
4.4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations 
arising out of the approved quality system. 
4.4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of 
manufacture, inspection and testing, and storage and shall provide it with all necessary information, 
in particular; 
— the quality system documentation, 
— the design documentation, 
— the quality records, such as inspection reports and test data, calibration data, qualification 
reports of the personnel concerned, etc. 
4.4.3. The notified body shall make sure that the manufacturer maintains and applies the quality system 
and shall provide a surveillance report to the manufacturer. 
ANNEX 3 
Devices shall be identified by the manufacturer by means of type, batch or serial numbers. 
ANNEX 4 
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES WHEN 
APPOINTING INSPECTION BODIES 
1. The notified body, its director and the staff responsible for carrying out the verification tests shall not 
be the designer, manufacturer, supplier or installer of apparatus which they inspect, nor the authorized 
representative of any of those parties. They shall not become directly involved in the design, 
construction, marketing or maintenance of the apparatus, nor represent the parties engaged in these 
activities. This does not preclude the possibility of exchanges of technical information between the 
manufacturer and the notified body. 
No C 14/14 Official Journal of the European Communities 18. 1. 89 
2. The notified body and its staff must carry out the verification tests with the highest degree of 
professional integrity and technical competence 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 result of verifications. 
3. The notified body must have at its disposal the necessary staff and possess the necessary facilities to 
enable it to perform properly the administrative and technical tasks connected with verification; it must 
also have access to the equipment required for special verification. 
4. The staff responsible for inspection must have: 
— sound technical and professional training, 
— satisfactory knowledge of the requirements of the tests they carry out and adequate experience of 
such tests, 
— the ability to draw up the certificates, records and reports required to authenticate the performance 
of the tests. 
5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the 
number of tests carried out nor on the results of such tests. 
6. The notified body must take out liability insurance unless its liability is assumed by the State in 
accordance with national law, or the Member State itself is directly responsible for the tests. 
7. The staff of the notified body is bound to observe professional secrecy with regard to all information 
gained in carrying out its tasks (except vis-a-vis the competent administrative authorities of the State in 
which its activities are carried out) under this Directive or any provision of national law giving effect to 
it. 
ANNEX 5 
CLINICAL EVALUATION 
Clinical evaluation can be checked by means of clinical tests performed according to the following points: 
1. Clinical tests shall be performed in a recognized clinical environment specific for the pathologies that 
the device is intended to treat. 
2. Clinical tests shall be performed under the responsibility of a recognized consultant specialist in the 
relevant pathology. 
3. The procedures utilized to perform clinical tests shall be consistent with the device under examination. 
4. Methods to perform the tests shall be consistent with the device under examination. 
5. All appropriate features involving safety of the device shall be examined.