No C 211/12 Official Journal of the European Communities 17. 8. 89 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the approximation of the laws of the Member States 
concerning telecommunications terminal equipment, including the mutual recognition of their 
conformity 
COM(89) 289 final — SYN 204 
(Submitted by the Commission on 7 July 1989) 
(89/C 211/14) 
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 Council Directive 86/361 /EEC (*) introduced 
the initial stage of the mutual recognition of type 
approval for telecommunications terminal equipment and 
in particular in its Article 9 envisaged a further stage for 
full mutual recognition of type approval for terminal 
equipment; 
Whereas Council Decision 87/95/EEC (2) sets out the 
measures to be implemented for the promotion of stan­
dardization in Europe and the preparation and 
implementation of standards in the field of information 
technology and telecommunications; 
Whereas the Commission has issued a Green Paper on 
the development of the common market for telecommu­
nications services and equipment (3) proposing to 
accelerate the introduction of the full mutual recognition 
of type approval as the measure vital for the development 
of a competitive Community-wide terminal market; Whereas the Council in its Resolution of 30 June 1988 
on the development of the common market for telecom­
munications services and equipment up to 1992 (*) 
considers as a major goal in the telecommunications 
policy the full mutual recognition of type approval for 
terminal equipment on the basis of the rapid devel­
opment of common European conformity specifications; 
Whereas the terminal equipment sector is a vital part of 
the telecommunications industry which is one of the 
industrial mainstays of the Community economy; 
Whereas the Council Resolution of 7 May 1985 (5) 
provides fqr a new approach to technical harmonization 
and standards; 
Whereas the field of application of the Directive must be 
based on a general definition of the term 'terminal 
equipment' so as to allow the technical development of 
products; 
Whereas Community law, in its present form, provides 
— notwithstanding one of the fundamental rules of the 
Community, namely the free movement of goods — that 
obstacles to movement within the Community, resulting 
from disparities in national legislation relating to the 
marketing of products, must be accepted insofar as such 
requirements can be recognized as being necessary to 
satisfy imperative requirements; whereas, therefore, the 
harmonization of laws in this case must be limited only 
to those requirements necessary to satisfy the essential 
requirements relating to terminal equipment; whereas 
these requirements must replace the relevant national 
requirements because they are essential; 
Whereas the essential requirements must be satisfied in 
order to safeguard the general interest; whereas these 
requirements must be applied with discernment to take 
account of the state of the art at the time of manufacture 
and economic requirements; 
(•) OJ No L 217, 5. 8. 1986, p. 21. 
(2) OJ No L 36, 7. 2. 1987, p. 31. 
(J) COM (87) 290. (4) OJ No C 257, 4. 10. 1988, p. 1. 
(') OJ No C 136, 4. 6. 1985, p. 1. 
17. 8. 89 Official Journal of the European Communities No C 211/13 
Whereas Council Directive 73/23/EEC of 19 February 
1973 on the harmonization of the laws of the Members 
States relating to electrical equipment designed for use 
within certain voltage limits (') and 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 regulations (2), as amended by 
Directive 88/182/EEC (3), are applicable, inter alia; to 
the fields of telecommunications and information tech­
nology; 
Whereas Council Directive 89/336/EEC of 3 May 1989 
on the approximation of the laws of Member States 
relating to electromagnetic compatibility (4) is applicable, 
inter alia, to the fields of telecommunications and infor­
mation technology; 
Whereas in respect of the essential safety requirements 
and in order to help manufacturers to prove conformity 
to these essential requirements it is desirable to have 
standards harmonized at European level for the 
prevention of hazards arising out of the design and 
manufacture of terminal equipment and in order to allow 
checks of conformity to the essential requirements; 
whereas these standards harmonized at European level 
are drawn up by private-law bodies and must retain their 
non-binding status; whereas for this purpose the 
European Committee for Standardization (CEN) and 
the European Committee for Electrotechnical Standardi­
zation (CENELEC) are the bodies recognized as 
competent to adopt harmonized standards in accordance 
with the general guidelines for cooperation between the 
Commission and these two bodies signed in 13 
November 1984; whereas within the meaning of this 
Directive a harmonized standard is a technical specifi­
cation (European standard or harmonization document) 
adopted by either or both of these bodies, on the basis of 
a remit from the Commission in accordance with the 
provisions of Directive 83/189/EEC, and on the basis of 
the general guidelines referred to above; 
Whereas the formal adoption of the statutes of the 
European Telecommunications Standards Institute 
(ETSI) on 12 February 1988 creates a new opportunity 
to produce harmonized standards in the telecommuni­
cations field, whereas after implementation by the 
Member States of the ETSI rules of procedures which 
depend on their authority it will be possible to introduce 
ETSI into the framework of European standardization as 
stipulated in Directive 83/189/EEC; 
O OJ No L 77, 26. 3. 1973, p. 29. 
(2) OJ No L 109, 26. 4. 1983, p. 8. 
(3) OJ No L 81, 26. 3. 1988, p. 75. 
(4) OJ No L 139, 23. 5. 1989, p. 19. Whereas in respect of the essential requirements related 
to interworking with public telecommunications 
networks, it is in general not possible to comply with 
such requirements other than by the application of 
unique solutions; whereas such solutions shall therefore 
be mandatory; 
Whereas it is appropriate to set up a committee bringing 
together parties directly concerned with the implemen­
tation of this Directive, in particular the national bodies 
designated for certifying conformity, to assist the 
Commission in executing the tasks entrusted to it by this 
Directive; 
Whereas the Member States' responsibility for safety, 
health and the other aspects covered by the essential 
requirements on their territory must be recognized in a 
safeguard clause providing for adequate Community 
protection procedures; 
Whereas the addressees of any decision taken under this 
Directive must be informed of the reasons for such a 
decision and the means of appeal open to them; 
Whereas the measures aimed at the gradual estab­
lishment of the internal market must be adopted by 31 
December 1992; whereas the internal market consists of 
an area without internal frontiers within which the free 
movement of goods, persons, services and capital is 
guaranteed, 
HAS ADOPTED THIS DIRECTIVE: 
CHAPTER I 
Scope, placing on the market and free movement 
Article 1 
1. This Directive shall apply to terminal equipment. 
2. For the purposes of this Directive terminal 
equipment means equipment intended: 
(a) to be connected to the termination of a public tele­
communications network by an electrically 
conductive system, 
and/or 
(b) to interwork with a public telecommunications 
network, 
and/or 
(c) to interwork via a public telecommunications 
network. 
For cases (b) and (c) the system of connection to support 
the interworking may be wire, radio, optical, or other 
electromagnetic systems. 
No C 211/14 Official Journal of the European Communities 17. 8. 89 
Article 2 
Member States shall take all necessary steps to ensure 
that terminal equipment may be placed on the market 
and put into service only if it complies with the 
requirements laid down in this Directive when it is 
properly installed and maintained and used for its 
intended purpose. 
Article 3 
Terminal equipment shall satisfy the following essential 
requirements, when they are relevant: 
(a) user safety insofar as this requirement is not covered 
by Directive 73/23/EEC; 
(b) safety of employees of public network operators 
insofar as this requirement is not covered by 
Directive 73/23/EEC; 
(c) protection of the telecommunications network from 
harm; 
(d) interworking of terminal equipment with network 
equipment for the purpose of establishing, 
modifying, charging for, and clearing real or virtual 
connections; 
(e) interworking of terminal equipment, in justified 
cases. 
Article 4 
Member States shall not impede the placing on the 
market and the free circulation and use on their territory 
of terminal equipment which complies with the 
provisions of this Directive. 
Article 5 
1. Member States shall presume compliance with the 
essential requirements referred to in Article 3 (a) and (b) 
in respect of terminal equipment which is in conformity 
with the national standards implementing the relevant 
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. 
2. The Commission, in accordance with the procedure 
laid down in Article 13, shall decide which harmonized 
standards, implementing the essential requirements 
referred to in Article 3 (c), (d) and (e) will be trans­
formed into technical regulations compliance with which 
shall be mandatory and the references of which shall be 
published in the Official Journal of the European 
Communities. 
Article 6 
Where a Member State or the Commission considers 
that the harmonized standards referred to in Article 5 do 
not entirely meet the essential requirements referred to in 
Article 3, the Commission or the Member State 
concerned shall bring the matter before the Committee 
referred to in Article 12, hereinafter referred to as 'the 
Committee', giving the reasons therefore. The 
Committee shall deliver an opinion without delay. In the light of the Committee's opinion and after consul­
tation of the standing Committee set up by Directive 
83/189/EEC, the Commission shall inform the Member 
States whether or not it is necessary to withdraw 
references to those standards and any related technical 
regulations from the Official Journal of the European 
Communities. 
Article 7 
1. Where a Member State finds that terminal 
equipment bearing the CE mark under the provisions 
laid down in chapter III, does not comply with the 
relevant essential requirements when properly used in 
accordance with its intended purpose, it shall take all 
appropriate measures to withdraw such products from 
the market or to prohibit or restrict their being placed on 
the market. 
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) incorrect application of the harmonized standards 
referred to in Article 5; 
(b) shortcomings in the harmonized standards referred 
to in Article 5 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 harmonized 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 terminal equipment which does not comply 
with the relevant essential requirements bears the CE 
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 keep the Member States 
informed of the progress and outcome of this procedure. 
17. 8. 89 Official Journal of the European Communities No C 211/15 
CHAPTER II CHAPTER III 
Conformity assessment CE mark of conformity and inscriptions 
Article 10 
Article 8 
1. According to the choice of the manufacturer or his 
authorized representative established within the 
Community, terminal equipment shall be subject to either 
EC type examination, as described in Annex 1, or to EC 
declaration of conformity, as described in Annex 4. 
2. An EC type examination as described in Annex 1 
shall be accompanied by a declaration issued according 
to the EC declaration of conformity to type procedure as 
described in Annex 2 or Annex 3. 
3. The records and correspondence relating to the 
procedures referred to in this Article shall be in an 
official language of the Member State where the said 
procedure will be carried out, or in a language 
acceptable to the notified body involved. 
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 keep the list up to date. 
2. Member States shall apply the minimum criteria, set 
out in Annex 5, 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 5. 
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. 
4. In order to facilitate the determination of 
conformity of terminal equipment with technical regu­
lations and standards, the notified bodies shall recognize 
documentation issued by third country relevant bodies, 
when agreements between the Community and the third 
country concerned have been concluded on the basis of a 
mutually satisfactory understanding. 1. The CE mark of conformity, which shall consist of 
the symbol 'CE' in conformity with the specimen in 
Annex 6, shall be affixed to terminal equipment in a 
clearly visible, easily legible and indelible form. It shall 
be followed by the last two digits of the year in which it 
was affixed. 
2. The affixing of marks which are likely to be 
confused with the CE mark of conformity shall be 
prohibited. 
3. Terminal equipment shall be identified by the 
manufacturer by means of type, batch, or serial numbers. 
Article 11 
Where it is established that the CE mark has been 
affixed to terminal equipment which: 
— does not conform to an approved type, 
— conforms to an approved type which does not meet 
the essential requirements applicable to it, 
or, where the manufacturer has failed to fulfil his obli­
gations under the relevant EC declaration of conformity, 
the notified body shall withdraw the EC type exam­
ination certificate, as referred to in Annex 1, the EC 
quality system approval certificate, as referred to in 
Annex 3 or the EC design examination certificate as 
referred to in Annex 4, as relevant, notwithstanding any 
decisions taken under Article 7. 
CHAPTER TV 
Committee 
Article 12 
A standing Committee for terminal equipment is hereby 
set up. The Committee shall be called the Approvals 
Committee for Telecommunications Equipment (ACTE). 
The Committee shall be composed of representatives 
appointed by the Member States. It shall be chaired by a 
representative of the Commission. Each Member State 
shall appoint two representatives. The representatives 
may be accompanied by experts. 
The Committee shall draw up its own rules of procedure. 
Article 13 
1. The representative of the Commission shall submit 
to the Committee established in Article 12, a draft of the 
measures to be taken as referred to in Article 5.2. 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. 
No C 211/16 Official Journal of the European Communities 17. 8. 89 
2. The Commission shall adopt the measures 
envisaged if they are in accordance with the opinion of 
the Committee. 
3. 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 qualified majority. If, 
within three months of the proposal being submitted to 
it, the Council has not acted, the proposed measures 
shall be adopted by the Commission. 
CHAPTER V 
Final and transitional provisions 
Article 14 
1. Where, for a given terminal equipment, 
harmonized standards as referred to in Article 5 do not 
exist, national conformity specifications shall be 
applicable. These national conformity specifications shall 
not impose requirements beyond those strictly necessary 
to respect the essential requirements set out in Article 3. 
The right to place on the market terminal equipment, 
which has received national type approval on the basis of 
national conformity specifications, may be limited to the 
territory of the Member State where the national 
conformity specification applies except if it complies with 
a national specification of another Member State and is 
intended for re-sale or for use in this Member State. 2. A national authority shall recognize, for the 
purpose of national type approval, a certificate of 
conformity to its own national conformity specification, 
accompanied by the appropriate test reports, which has 
been issued by a notified body of another Member State 
and shall not impose a requirement for any repetition of 
tests. 
A national authority shall recognize, for the purpose of 
national type approval, a certificate of conformity based 
on the national conformity specifications of another 
Member State provided that these conformity specifi­
cations are equivalent to those used in the Member State 
of the authority. 
Article 15 
Directive 86/361/EEC is hereby repealed with effect 
from 1 January 1990. 
Article 16 
1. Member States shall introduce the measures 
necessary to comply with this Directive not later than 
1 January 1990. They shall forthwith inform the 
Commission thereof. 
The provisions adopted pursuant to the first 
subparagraph shall make express reference to this 
Directive. 
2. Member States shall inform the Commission of the 
provisions of national law which they adopt in the field 
governed by this Directive. 
Article 17 
This Directive is addressed to the Member States. 
ANNEX 1 
EG type examination 
1. The EC type examination is that part of the procedure by which a notified body ascertains and attests 
that terminal equipment, representative of the production envisaged and hereinafter called the 'type', 
conforms to the essential requirements that apply to it. 
2. The application for EC type examination shall be lodged by the manufacturer or his authorized 
representative established within the Community with one of the notified bodies designated to carry out 
EC type examination. 
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 technical documentation, as described in paragraph 3. 
The applicant shall place the type, in the required quantity, at the disposal of the notified body. 
3. The technical documentation shall enable understanding of the design, manufacture and operation of 
the product, and shall enable assessment of conformity of the product with the essential requirements 
that apply to it. 
17. 8. 89 Official Journal of the European Communities No C 211/17 
The documentation shall contain so far as relevant for assessment: 
— a general description of the type, 
— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, 
etc., 
— descriptions and explanations necessary for the understanding of said drawings and schemes and the 
operation of the product, 
— a list of the standards referred to in Article 5, applied in full or in part, declarations of conformity to 
the standards referred to in Article 5.1 where such standards have been applied, and descriptions of 
the solutions adopted to meet the essential requirements where the standards referred to in Article 
5.1 have not been applied, 
— results of design calculations made, examinations carried out, etc., 
— test reports. 
4. The notified body shall, 
4.1. examine the technical documentation, verify that the type has been manufactured in conformity 
with the technical documentation and identify the elements which have been designed in 
accordance with the relevant provisions of the standards referred to in Article 5.1, as well as the 
elements which have been designed without applying the relevant provisions of those standards; 
4.2. perform or have performed the appropriate examinations and necessary tests to check whether, 
where the standards referred to in Article 5.1 have not been applied, the solutions adopted by the 
manufacturer meet the essential requirements of the directive referred to in Article 3 (a) and (b); 
4.3. perform or have performed the appropriate examinations and necessary tests to check that the type 
complies with the relevant harmonized standards referred to in Article 5.2; 
5. Where the type conforms to the applicable essential requirements the notified body shall issue an EC 
type examination certificate to the applicant. The certificate shall contain the name and address of the 
manufacturer, conclusions of the examination, conditions for its validity and the necessary data for 
identification of the approved type. 
Relevant parts of the technical documentation shall be annexed to the certificate and kept by the 
notified body. 
6. The applicant shall keep the notified body that has issued the EC type examination certificate informed 
of any modification to the approved type. 
Modifications to the approved type must receive additional approval from the notified body that issued 
the EC type examination certificate where such changes may affect the conformity with the essential 
requirements or the prescribed conditions for use of the product. This additional approval is given in the 
form of an addition to the original EC type examination certificate. 
7. Each notified body shall publish periodically the relevant information concerning: 
— the applications for EC type examination received, 
— the EC type examination certificates and additions issued, 
— the EC type examination certificates and additions refused, 
— the EC type examination certificates and additions withdrawn. 
8. The other notified bodies may receive copies of the EC type examination certificates and/or their 
additions and any annexes. 
No C 211/18 Official Journal of the European Communities 17. 8. 89 
ANNEX 2 
EC declaration of conformity to type 
1. This declaration of conformity is that part of the procedure whereby the manufacturer ensures and 
declares that the products concerned are in conformity with the type as described in the EC type exam­
ination certificate and satisfy the requirements of the Directive that apply to them. The manufacturer 
shall affix the CE mark to each product and draw up a written declaration of conformity. 
2. The manufacturer shall take all measures necessary in order that the manufacturing process shall ensure 
compliance of the manufactured products with the type as described in the EC type examination 
certificate and with the requirements of the Directive that apply to them. 
3. A notified body chosen by the manufacturer shall carry out or have carried out product checks at 
random intervals. An adequate sample of the final products, taken on site by the notified body, shall be 
examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5, shall be 
carried out to check the conformity of the production output with the relevant requirements of the 
Directive. In those cases where one or more of the products checked do not conform the notified body 
shall take appropriate measures. 
ANNEX 3 
EC declaration of conformity to type (production Quality Assurance) 
1. This declaration of conformity is that part of the procedure whereby a manufacturer who satisfies the 
obligations of paragraph 2 ensures and declares that the products concerned are in conformity with the 
type as described in the EC type examination certificate and satisfy the requirements of the Directive 
that apply to them. The manufacturer shall affix the CE mark to each product and shall draw up a 
written declaration of conformity. 
2. The manufacturer shall operate an approved quality system for production, final product inspection and 
testing as specified in paragraph 3 and shall be subject to EC surveillance as specified in paragraph 4. 
3. Quality system 
3.1. The manufacturer shall lodge an application for assessment of his quality system with one of the 
notified bodies designated to carry out quality system approval. 
The application shall include: 
— all relevant information for the product category envisaged, 
— the quality system's documentation, 
— an undertaking to carry out the obligations arising from the quality system as approved, 
— an undertaking to maintain the quality system as approved to ensure its continuing suitability 
and effectiveness, 
— if applicable, the technical documentation of the approved type and a copy of the EC type 
examination certificate. 
3.2. The quality system shall ensure compliance of the products with the type as described in the EC 
type examination certificate and with the requirements of the Directive that 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 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 organization structure, responsibilities and powers of the 
management with regard to product quality, 
17. 8. 89 Official Journal of the European Communities No C 211/19 
— the manufacturing, quality control and quality assurance techniques, processes 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. 
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements 
referred to in paragraph 3.2. It shall presume conformity with these requirements in respect of 
quality systems that implement the relevant harmonized standard. 
The assessment team shall have at least one member experienced as an assessor in the product 
technology concerned. The evaluation procedure shall include an assessment visit to the manu­
facturer's premises. 
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of 
the examination and the reasoned assessment decision. Where the notified body decides to approve 
the quality system, it shall issue an EC quality system approval certificate. 
3.4. The manufacturer or his authorized representative shall keep the notified body that has approved 
the quality system informed of any intended modification to the quality system. 
The notified body shall evaluate the modifications proposed and decide whether the amended 
quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reas­
sessment is required. 
It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the 
examination and the reasoned assessment decision. 
4. EC surveillance 
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. 
4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of 
manufacture, inspection, testing and storage and shall provide it with all necessary information, in 
. particular: 
— the quality system documentation, 
— the quality records, such as inspection reports and test data, calibration data, qualification 
reports of the personnel concerned, etc. 
4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains 
and applies the quality system and shall provide an audit report to the manufacturer. 
4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such visits 
full or reduced audits may be carried out by the notified body. The notified body shall provide a 
visit report and, if applicable, an audit report to the manufacturer. 
5. Each notified body shall publish periodically the relevant information concerning the EC quality system 
approval certificates issued and withdrawn. 
i^oCM^n^o C^ffici^Journ^lofr^Euro^^nC^ornrnunin^ 1^ ^ ^ 
1. This declaration of conformity is the procedure whereby the manufacturer who satisfies the obligations 
of paragraph 2 ensures and declares that the products concerned satisfy the requirements of the 
directive that apply to them.The manufacturer shall affi^ the 0^^ market to each product and draw up 
awritten declaration of conformity. 
2. Themanufacturershalloperateanapproved quality system for design, manufacture and finalproduct 
inspection and testing as specified in paragraph^and shall be subject to^surveillance as specified in 
paragraphs. 
^.t. Themanufacturer shalllodgean applicationfor assessment of his quality system with anotified 
body. 
The application shall included 
— all relevant information for the product category envisaged, 
— the quality systenBsdocumentation, 
— an undertaking to carry out the obligations arising from the quality system as approved, 
— anunderta^ingtomaintain thequalitysystemasapprovedtoensureitscontinuingsuitability 
and effectiveness. 
^.2. The quality system shall ensure compliance of the products with the requirements of the directive 
that apply to them. 
^11 the elements, requirements and provisions adopted by the manufacturer shall be documented in 
asystematic and orderly manner in the form of written policies, procedures and instructions.This 
quality system documentation shall ensure a common understanding of the quality policies and 
procedures such as quality programmes, plans, manuals and records. 
tt shall contain in particular an adequate description of^ 
— the quality objectives and the organisational structure, responsibilities and powers of the 
management with regard to design and product quality, 
— the technical design specifications including harmonised standards and technical regulations laid 
down in Articled, 
— the design control and design verification techniques, processes and systematic actions that will 
be used when designing the products pertaining to the product category covered, 
— the corresponding manufacturing, quality control and quality assurance techniques, processes 
and systematic actions that will be used, 
— the e^aminationandtests that will be carriedoutbefore,during, and after manufacture,and 
the frequency with which they will be carried out, 
— the means by which it is ensured that the test and examination facilities respect the requirements 
for notified bodies designated for testing, 
— the means to monitor the achievement of the required design and product quality and the 
effective operation of the quality system. 
^. The notified body shall assess the quality system to determine whether it satisfies the requirements 
referred to inparagraph ^.2. itshallpresume compliance with theserequirements in respectof 
quality systems that implement the relevant harmonised standard. ^i.e.^^C2^00n 
The assessmentteam shall have at least one member experienced as an assessor in theproduct 
technology concerned. The evaluation procedure shall include an assessment visit to the manuD 
facturer^spremises. 
17. 8. 89 Official Journal of the European Communities No C 211/21 
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of 
the examination and the reasoned assessment decision. 
3.4. The manufacturer or his authorized representative shall keep the notified body that has approved 
the quality system informed of any intended updating of the quality system. 
The notified body shall evaluate the modifications proposed and decide whether the amended 
quality system will still satisfy the requirements referred to in paragraph 3.2. or whether a reas­
sessment is required. 
It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the 
examination and the reasoned assessment decision. 
4. EC surveillance 
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. 
4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of 
design, manufacture, inspection and testing and storage, and shall provide it with all necessary 
information, in particular: 
— the quality system documentation, 
— the quality records as foreseen by the design part of the quality system, such as results of 
analyses, calculations, tests, etc., 
— the quality records as foreseen by the manufacturing part of the quality system, such as 
inspection reports and test data, calibration data, qualification reports of the personnel 
concerned, etc. 
4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains 
and applies the quality system and shall provide an audit report to the manufacturer. 
4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such visits 
full or reduced audits may be carried out by the notified body. The notified body shall provide a 
visit report and, if applicable, an audit report to the manufacturer. 
5. Each notified body shall publish periodically the relevant information concerning the quality system 
approvals issued and withdrawn. 
6. Design examination 
6.1. The manufacturer shall lodge an application for examination of the design with a notified body. 
6.2. The application shall enable understanding of the design, manufacture and operation of the 
product, and shall enable assessment of conformity with the relevant requirements of the Directive. 
It shall include: 
— the technical design specifications, including harmonized standards and technical regulations 
laid down in Article 5 thft have been applied, 
— the necessary supporting evidence for their adequacy; this supporting evidence shall include the 
results of tests carried out by an inhouse notified body designated for testing or on behalf of the 
manufacturer by a notified body designated for testing. 
6.3. The notified body shall examine the application and where the design meets the provisions of the 
Directive that apply to it shall issue an EC design examination certificate to the applicant. The 
certificate shall contain the conclusions of the examination, conditions for its validity, the necessary 
data for identification of the approved design and, if relevant, a description of the product's func­
tioning. 
No C 211/22 Official Journal of the European Communities 17. 8. 89 
6.4. The applicant shall keep the notified body that has issued the EC design examination certificate 
informed of any modification to the approved design. Modifications to the approved design must 
receive additional approval from the notified body that issued the EC examination certificate where 
such changes may affect the conformity with the essential requirements of the Directive or the 
prescribed conditions for use of the product. This additional approval is given in the form of an 
addition to the original EC design examination certificate. 
6.5. The notified bodies shall publish periodically the relevant information concerning: 
— the applications for EC-design examination received, 
— the EC design examination certificates and additions issued, 
— the EC design examination certificates and additions reissued, 
— the EC design examination certificates and additions refused, 
— the EC design approvals and additional approvals withdrawn. 
ANNEX 5 
Minimum criteria to be taken into account by Member States when appointing notified bodies. 
1. The notified body, its director and the staff responsible for carrying out the tasks for which the notified 
body has been designated shall not be a designer, manufacturer, supplier or installer of terminal 
equipment, nor the authorized representative of any of such parties. They shall not become directly 
involved in the design, construction, marketing or maintenance of terminal equipment, nor represent the 
parties engaged in these activities. This does not preclude the possibility of exchanges of technical infor­
mation between the manufacturer and the notified body. 
2. The notified body and its staff must carry out the tasks for which the notified body has been designated 
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 
any tests or inspection, especially from persons or groups of persons with an interest in such results. 
3. The notified body must have at its disposal the necessary staff and facilities to enable it to perform 
properly the administrative and technical work associated with the tasks for which it has been 
designated. 
4. The staff responsible for tests or inspections must have: 
— sound technical and professional training, 
— satisfactory knowledge of the requirements of the tests or inspections they carry out and adequate 
experience of such tests or inspections, 
— the ability to draw up the certificates, records and reports required to authenticate the performance 
of the tests or inspections. 
5. The impartiality of test and inspection staff must be guaranteed. Their remuneration must not depend 
on the number of tests or inspections carried out nor on the results of such tests or inspections. 
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. 
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.