CELEX: 51989PC0289
Language: en
Date: 1989-07-27
Title: 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

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,                           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 (*)
Having regard to the Treaty establishing the European              considers as a major goal in the telecommunications
Economic Community, and in particular Article 100A                 policy the full mutual recognition of type approval for
thereof,                                                           terminal equipment on the basis of the rapid devel-
                                                                   opment of common European conformity specifications;
Having regard to the proposal from the Commission,                 Whereas the terminal equipment sector is a vital part of
                                                                   the telecommunications industry which is one of the
                                                                   industrial mainstays of the Community economy;
In cooperation with the European Parliament,
                                                                   Whereas the Council Resolution of 7 May 1985 (5)
                                                                   provides fqr a new approach to technical harmonization
Having regard to the opinion of the Economic and                   and standards;
Social Committee,
                                                                   Whereas the field of application of the Directive must be
                                                                   based on a general definition of the term 'terminal
Whereas Council Directive 86/361 / E E C (*) introduced
                                                                   equipment' so as to allow the technical development of
the initial stage of the mutual recognition of type
                                                                   products;
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              Whereas Community law, in its present form, provides
equipment;                                                         — 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
Whereas Council Decision 87/95/EEC (2) sets out the
                                                                   marketing of products, must be accepted insofar as such
measures to be implemented for the promotion of stan-
                                                                   requirements can be recognized as being necessary to
dardization in Europe and the preparation and
                                                                   satisfy imperative requirements; whereas, therefore, the
implementation of standards in the field of information
                                                                   harmonization of laws in this case must be limited only
technology and telecommunications;
                                                                   to those requirements necessary to satisfy the essential
                                                                   requirements relating to terminal equipment; whereas
                                                                   these requirements must replace the relevant national
Whereas the Commission has issued a Green Paper on
                                                                   requirements because they are essential;
the development of the common market for telecommu-
nications services and equipment (3) proposing to
accelerate the introduction of the full mutual recognition         Whereas the essential requirements must be satisfied in
of type approval as the measure vital for the development          order to safeguard the general interest; whereas these
of a competitive Community-wide terminal market;                   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.                                 (4) OJ No C 257, 4. 10. 1988, p. 1.
(J) COM (87) 290.                                                  (') OJ No C 136, 4. 6. 1985, p. 1.
 ---pagebreak--- 17. 8. 89                              Official Journal of the European Communities                                          N o C 211/13
Whereas Council Directive 73/23/EEC of 19 February               W h e r e a s in respect of the        essential requirements related
1973 on the harmonization of the laws of the Members             to        interworking       with        public      telecommunications
States relating to electrical equipment designed for use         n e t w o r k s , it is in general     n o t possible t o comply with
within certain voltage limits (') and Council Directive          such requirements o t h e r            t h a n by the application of
83/189/EEC of 28 March 1983 laying down a                        u n i q u e solutions; w h e r e a s   such solutions shall therefore
procedure for the provision of information in the field of       be m a n d a t o r y ;
technical standards and regulations (2), as amended by
Directive 88/182/EEC (3), are applicable, inter alia; to         W h e r e a s it is appropriate to set up a committee bringing
the fields of telecommunications and information tech-           t o g e t h e r parties directly c o n c e r n e d with the implemen-
nology;                                                          tation of this Directive, in particular the national bodies
                                                                 designated for certifying conformity, t o assist the
                                                                 Commission in executing the tasks entrusted to it by this
                                                                 Directive;
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,     W h e r e a s the M e m b e r States' responsibility for safety,
inter alia, to the fields of telecommunications and infor-       health a n d the o t h e r aspects covered by the essential
mation technology;                                               requirements o n their territory must be r e c o g n i z e d in a
                                                                 safeguard clause providing for a d e q u a t e C o m m u n i t y
                                                                 protection procedures;
Whereas in respect of the essential safety requirements          W h e r e a s the addressees of any decision t a k e n u n d e r this
and in order to help manufacturers to prove conformity           Directive must be informed of the reasons for such a
to these essential requirements it is desirable to have          decision a n d the means of appeal open to t h e m ;
standards harmonized at European level for the
prevention of hazards arising out of the design and              W h e r e a s the measures aimed at the g r a d u a l estab-
manufacture of terminal equipment and in order to allow           lishment of the internal m a r k e t must be a d o p t e d by 31
checks of conformity to the essential requirements;               D e c e m b e r 1992; whereas the internal m a r k e t consists of
whereas these standards harmonized at European level              an area w i t h o u t internal frontiers within w h i c h the free
are drawn up by private-law bodies and must retain their          m o v e m e n t of g o o d s , persons, services and capital is
non-binding status; whereas for this purpose the                 guaranteed,
European Committee for Standardization (CEN) and
the European Committee for Electrotechnical Standardi-
zation (CENELEC) are the bodies recognized as                     HAS A D O P T E D THIS DIRECTIVE:
competent to adopt harmonized standards in accordance
with the general guidelines for cooperation between the
Commission and these two bodies signed in 13                                                    CHAPTER I
November 1984; whereas within the meaning of this
Directive a harmonized standard is a technical specifi-                 Scope, placing o n the m a r k e t a n d free m o v e m e n t
cation (European standard or harmonization document)
adopted by either or both of these bodies, on the basis of                                         Article 1
a remit from the Commission in accordance with the
provisions of Directive 83/189/EEC, and on the basis of           1.       This Directive shall apply to terminal equipment.
the general guidelines referred to above;
                                                                  2.        For the purposes of this Directive                      terminal
                                                                  equipment means equipment intended:
Whereas the formal adoption of the statutes of the                (a) to be connected to the termination of a public tele-
European Telecommunications            Standards    Institute            communications           network          by     an     electrically
(ETSI) on 12 February 1988 creates a new opportunity                     conductive system,
to produce harmonized standards in the telecommuni-
cations field, whereas after implementation by the                       and/or
Member States of the ETSI rules of procedures which
depend on their authority it will be possible to introduce        (b) to interwork with                a public       telecommunications
ETSI into the framework of European standardization as                   network,
stipulated in Directive 83/189/EEC;
                                                                         and/or
                                                                  (c) to interwork            via     a     public    telecommunications
                                                                         network.
 O OJ No L 77, 26. 3. 1973, p. 29.
 (2) OJ N o L 109, 26. 4. 1983, p. 8.                             For cases (b) and (c) the system of connection to support
 (3) OJ N o L 81, 26. 3. 1988, p. 75.                             the interworking may be wire, radio, optical, or other
 (4) OJ N o L 139, 23. 5. 1989, p. 19.                            electromagnetic systems.
 ---pagebreak---  No C 211/14                            Official Journal of the European Communities                                  17. 8. 89
                           Article 2                                In the light of the Committee's opinion and after consul-
                                                                    tation of the standing Committee set up by Directive
 Member States shall take all necessary steps to ensure
                                                                    83/189/EEC, the Commission shall inform the Member
 that terminal equipment may be placed on the market
                                                                    States whether or not it is necessary to withdraw
 and put into service only if it complies with the
                                                                    references to those standards and any related technical
 requirements laid down in this Directive when it is               regulations from the Official Journal of the European
 properly installed and maintained and used for its                 Communities.
 intended purpose.
                          Article 3
 Terminal equipment shall satisfy the following essential                                     Article 7
 requirements, when they are relevant:
                                                                    1.    Where a Member State finds that terminal
 (a) user safety insofar as this requirement is not covered        equipment bearing the CE mark under the provisions
     by Directive 73/23/EEC;                                       laid down in chapter III, does not comply with the
                                                                   relevant essential requirements when properly used in
 (b) safety of employees of public network operators
                                                                   accordance with its intended purpose, it shall take all
     insofar as this requirement is not covered by
                                                                   appropriate measures to withdraw such products from
     Directive 73/23/EEC;
                                                                   the market or to prohibit or restrict their being placed on
 (c) protection of the telecommunications network from             the market.
     harm;
 (d) interworking of terminal equipment with network
     equipment for the purpose of establishing,                    The Member State concerned shall immediately inform
     modifying, charging for, and clearing real or virtual         the Commission of any such measure indicating the
     connections;                                                  reasons for its decision, and in particular whether
 (e) interworking of terminal equipment, in justified              non-compliance is due to:
     cases.
                          Article 4                                (a) incorrect application of the harmonized standards
                                                                        referred to in Article 5;
 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.                                      (b) shortcomings in the harmonized standards referred
                                                                        to in Article 5 themselves.
                          Article 5
 1.   Member States shall presume compliance with the
essential requirements referred to in Article 3 (a) and (b)       2.     The Commission shall enter into consultation with
in respect of terminal equipment which is in conformity           the parties concerned as soon as possible. Where, after
with the national standards implementing the relevant             such consultation, the Commission finds that any
harmonized standards the references of which have been            measure as referred to in paragraph 1 is justified it shall
published in the Official Journal of the European                 immediately so inform the Member State that took the
 Communities.- Member States shall publish the references         action and the other Member States. Where the decision
of such national standards.                                       referred to in paragraph 1 is attributed to shortcomings
                                                                  in the harmonized standards, the Commission, after
2.    The Commission, in accordance with the procedure            consulting the parties concerned, shall bring the matter
laid down in Article 13, shall decide which harmonized            before the Committee within two months if the Member
standards, implementing the essential requirements                State which has taken the measures intends to maintain
referred to in Article 3 (c), (d) and (e) will be trans-          them, and shall initiate the procedures referred to in
formed into technical regulations compliance with which           Article 6.
shall be mandatory and the references of which shall be
published in the Official Journal of the European
Communities.
                                                                  3.     Where terminal equipment which does not comply
                          Article 6                              with the relevant essential requirements bears the CE
                                                                  mark the competent Member State shall take appropriate
Where a Member State or the Commission considers                  action against whomsoever has affixed the mark and
that the harmonized standards referred to in Article 5 do         shall inform the Commission and the other Member
not entirely meet the essential requirements referred to in       States thereof.
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       4.     The Commission shall keep the Member States
Committee shall deliver an opinion without delay.                 informed of the progress and outcome of this procedure.
 ---pagebreak---   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.    The CE mark of conformity, which shall consist of
  1.    According to the choice of the manufacturer or his           the symbol 'CE' in conformity with the specimen in
 authorized     representative     established     within   the      Annex 6, shall be affixed to terminal equipment in a
 Community, terminal equipment shall be subject to either            clearly visible, easily legible and indelible form. It shall
 EC type examination, as described in Annex 1, or to EC              be followed by the last two digits of the year in which it
 declaration of conformity, as described in Annex 4.                 was affixed.
                                                                     2.    The affixing of marks which are likely to be
                                                                     confused with the CE mark of conformity shall be
 2.     An EC type examination as described in Annex 1               prohibited.
 shall be accompanied by a declaration issued according
 to the EC declaration of conformity to type procedure as            3.    Terminal equipment shall be identified by the
 described in Annex 2 or Annex 3.                                    manufacturer by means of type, batch, or serial numbers.
                                                                                               Article 11
 3.     The records and correspondence relating to the              Where it is established that the CE mark has been
 procedures referred to in this Article shall be in an               affixed to terminal equipment which:
 official language of the Member State where the said
                                                                    — does not conform to an approved type,
 procedure will be carried out, or in a language
 acceptable to the notified body involved.                          — 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-
                           Article 9                                gations under the relevant EC declaration of conformity,
                                                                    the notified body shall withdraw the EC type exam-
 1.     Member States shall notify to the other Member              ination certificate, as referred to in Annex 1, the EC
 States and the Commission the bodies which they have               quality system approval certificate, as referred to in
 designated for carrying out tasks pertaining to the                Annex 3 or the EC design examination certificate as
 procedures referred to in Article 8, the specific tasks for        referred to in Annex 4, as relevant, notwithstanding any
 which each body has been designated, and the identifi-             decisions taken under Article 7.
 cation codes of the designated bodies.
                                                                                             CHAPTER TV
The Commission shall publish the list of these notified
 bodies together with the tasks for which they have been                                      Committee
 designated, in the Official Journal of the European
 Communities and shall keep the list up to date.                                               Article 12
                                                                    A standing Committee for terminal equipment is hereby
                                                                    set up. The Committee shall be called the Approvals
 2.    Member States shall apply the minimum criteria, set          Committee for Telecommunications Equipment (ACTE).
 out in Annex 5, for the designation of bodies. Bodies              The Committee shall be composed of representatives
that satisfy the criteria fixed by the relevant harmonized          appointed by the Member States. It shall be chaired by a
standards shall be presumed to satisfy the criteria set out         representative of the Commission. Each Member State
in Annex 5.                                                         shall appoint two representatives. The representatives
                                                                    may be accompanied by experts.
3.     A Member State that has designated a body shall              The Committee shall draw up its own rules of procedure.
annul the designation if the body no longer meets the
criteria for designation referred to in paragraph 2. It                                        Article 13
shall immediately inform the other Member States and                1.     The representative of the Commission shall submit
the Commission accordingly and withdraw the notifi-                 to the Committee established in Article 12, a draft of the
cation.                                                             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
4.     In order to facilitate the determination of                  to the urgency of the matter. The opinion shall be
conformity of terminal equipment with technical regu-               delivered by the majority laid down in Article 148 (2) of
lations and standards, the notified bodies shall recognize          the Treaty in the case of decisions which the Council is
documentation issued by third country relevant bodies,              required to adopt on a proposal from the Commission.
when agreements between the Community and the third                 The votes of the representatives of the Member States
country concerned have been concluded on the basis of a             within the Committee shall be weighted in the manner
mutually satisfactory understanding.                                set out in that Article. The chairman shall not vote.
 ---pagebreak---  No C 211/16                                Official Journal of the European Communities                                    17. 8. 89
 2.    The Commission shall adopt the measures                             2.     A national authority shall recognize, for the
envisaged if they are in accordance with the opinion of                    purpose of national type approval, a certificate of
the Committee.                                                             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
3.     If the measures envisaged are not in accordance
                                                                           and shall not impose a requirement for any repetition of
with the opinion of the Committee, or if no opinion is
                                                                           tests.
delivered, the Commission shall, without delay, submit
to the Council a proposal relating to the measures to be                   A national authority shall recognize, for the purpose of
taken. The Council shall act by qualified majority. If,                    national type approval, a certificate of conformity based
within three months of the proposal being submitted to                     on the national conformity specifications of another
it, the Council has not acted, the proposed measures                       Member State provided that these conformity specifi-
shall be adopted by the Commission.                                        cations are equivalent to those used in the Member State
                                                                           of the authority.
                          CHAPTER V                                                                   Article 15
                                                                           Directive 86/361/EEC is hereby repealed with effect
              Final and transitional provisions                           from 1 January 1990.
                            Article 14                                                                Article 16
1.    Where,       for    a given terminal            equipment,           1.     Member States shall introduce the measures
harmonized standards as referred to in Article 5 do not                   necessary to comply with this Directive not later than
exist, national conformity specifications shall be                         1 January 1990. They shall forthwith inform the
                                                                          Commission thereof.
applicable. These national conformity specifications shall
not impose requirements beyond those strictly necessary                   The provisions adopted pursuant to the first
to respect the essential requirements set out in Article 3.               subparagraph shall make express reference to this
                                                                          Directive.
The right to place on the market terminal equipment,
                                                                          2.      Member States shall inform the Commission of the
which has received national type approval on the basis of
                                                                          provisions of national law which they adopt in the field
national conformity specifications, may be limited to the
                                                                          governed by this Directive.
territory of the Member State where the national
conformity specification applies except if it complies with
                                                                                                     Article 17
a national specification of another Member State and is
intended for re-sale or for use in this Member State.                    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.
 ---pagebreak--- 17. 8. 89                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s               N o 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 E C
             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.
 ---pagebreak--- N o C 211/18                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s           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,
 ---pagebreak--- 17. 8. 89                               Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s             N o 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.
 ---pagebreak--- 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 p a r a g r a p h ^ a n d shall be subject t o ^ s u r v e i l l a n c e as specified in
           paragraphs.
           ^.t. Themanufacturer s h a l l l o d g e a n 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. i t s h a l l p r e s u m e 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 t h e p r o d u c t
                technology concerned. The evaluation procedure shall include an assessment visit to the manuD
                facturer^spremises.
 ---pagebreak--- 17. 8. 89                                 Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s             N o 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.
 ---pagebreak--- N o C 211/22                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s               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.