The Telecommunications Terminal Equipment Regulations 1992

PART III THE EC TYPE-EXAMINATION PROCEDURE

Application of Part III

13.  This Part shall have effect for providing for the manner in which the conformity assessment requirements may be complied with where the manufacturer or his authorised representative chooses the EC type-examination procedure.

The EC type-examination procedure

14.—(1) The EC type-examination procedure shall consist of two parts, as follows—

(a) EC type-examination;

(b) the EC declaration of conformity to type procedure.

(2) The EC declaration of conformity to type procedure shall consist of—

(a) either—

(i) conformity to type; or

(ii) production quality assurance; and

(b) the drawing up by the manufacturer of an EC declaration of conformity to type (which it is hereby declared for the avoidance of doubt may relate to any number of items of applicable terminal equipment).

The conformity assessment requirements pursuant to the EC type-examination procedure

15.  The conformity assessment requirements are complied with in relation to applicable terminal equipment pursuant to the EC type-examination procedure if—

(a) there is in force in respect of a type of that equipment an EC type-examination certificate issued by a notified body, or where the equipment is a modification, there is in force in respect thereof an additional approval issued by the notified body which issued the EC type-examination certificate in respect of the approved product from which the modification derives; and

(b) subject to regulation 36, the manufacturer has, having carried out conformity to type or production quality assurance, drawn up an EC declaration of conformity to type. EC type examination

EC type-examination

EC type-examination

16.  Regulations 17 to 23 below shall have effect in relation to EC type-examination, that is to say, that part of the procedure provided for in Annex I of the TTE Directive whereby a notified body ascertains and attests that a type meets the provisions of that Directive that apply to it.

Application for EC type-examination

17.—(1) The manufacturer of applicable terminal equipment or his authorised representative may lodge an application for the EC type-examination with a notified body of his choice.

(2) An application for EC type-examination made to a United Kingdom notified body shall be in English (or another language acceptable to the notified body) and shall include—

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition;

(b) a written declaration that the same application has not been lodged with any other notified body and that the applicable terminal equipment is intended for connection to the public telecommunications network; and

(c) the technical documentation,

and the applicant shall—

(i) place the type at the disposal of the United Kingdom notified body; and

(ii) comply with any request made by the United Kingdom notified body for further specimens if needed for carrying out the test programme.

EC type-examination by a United Kingdom notified body

18.—(1) In carrying out EC type-examination, a United Kingdom notified body shall—

(a) examine the technical documentation, verify that the type has been manufac-tured in conformity with it and identify the elements which have been designed in accordance with the relevant provisions of the harmonized national standards, as well as the components of those standards;

(b) perform, or have performed by a recognised test laboratory, the appropriate examinations and necessary tests to check whether the solutions adopted by the manufacturer meet the essential requirements referred to in sub-paragraphs (a) and (b) of regulation 5(1) above; and

(c) perform, or have performed by a recognised test laboratory, the appropriate examinations and necessary tests to check that the type meets the relevant common technical regulations.

(2) The United Kingdom notified body shall agree with the applicant on the location where the examinations and necessary tests referred to in paragraph (1) above which are to be conducted by or on behalf of that body are to be carried out.

(3) Where it appears to a United Kingdom notified body carrying out EC type-examination that the type does not meet the provisions of the TTE Directive, it shall, subject to regulation 54 below, refuse to grant the EC type-examination certificate.

EC type-examination certificates issued by United Kingdom notified bodies

19.—(1) Where it appears to a United Kingdom notified body carrying out EC type-examination that the type meets the provisions of the TTE Directive, it shall issue an EC type-examination certificate to the applicant.

(2) An EC type-examination certificate issued pursuant to paragraph (1) above shall contain—

(a) the name and address of the manufacturer;

(b) conditions for its validity and prescribed conditions for use of the product; and

(c) the necessary data for identification of the approved type,

and a list of the relevant parts of the technical documentation shall be annexed to the certificate.

Modifications to the approved type

20.—(1) An application for additional approval in respect of a modification to an approved product shall be made to the notified body that holds the technical documentation concerning the EC type-examination certificate for the approved product.

(2) An application for additional approval made to a United Kingdom body shall include—

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition;

(b) identifying particulars of the approved product to which the modification relates and its EC type-examination certificate; and

(c) the additional technical documentation,

and the applicant shall—

(i) place a specimen of the modification at the disposal of the United Kingdom notified body; and

(ii) comply with any request made by the United Kingdom notified body for further specimens if needed for carrying out the test programme.

(3) Regulation 18 above shall apply to an application made to a United Kingdom notified body for an additional approval as if references to the type were references to the modification, and references to the EC type-examination certificate were references to the additional approval, provided that the United Kingdom notified body shall only be required to carry out the procedures referred to in paragraph (1) thereof to the extent that it appears necessary to that body to determine the application.

Additional approvals issued by United Kingdom notified bodies

21.—(1) Where it appears to a United Kingdom notified body to which an application for additional approval has been made that the modification meets the provisions of the TTE Directive, it shall issue an additional approval to the applicant.

(2) An additional approval issued pursuant to paragraph (1) above shall contain—

(a) the name and address of the manufacturer;

(b) conditions for its validity and prescribed conditions for use of the modification; and

(c) the necessary data for identification of the modification, and the approved type to which it relates and the EC type-examination certificate in respect thereof,

and a list of the relevant parts of the additional technical documentation shall be annexed to the approval.

Variation of EC type-examination certificates and additional approvals issued by United Kingdom notified bodies

22.  A United Kingdom notified body which issued an EC type-examination certificate or an additional approval—

(a) may, at the request of the holder; or

(b) shall, subject to regulation 54 below, where it appears to that body to be necessary to ensure that products manufactured in accordance therewith meet the provisions of the TTE Directive,

vary the conditions for its validity or the prescribed conditions for use of the approved product or modification as the case may be.

Withdrawal of EC type-examination certificates and additional approvals

23.  Subject to regulation 54 below, where a United Kingdom notified body is satisfied that a type or modification in respect of which it issued an EC type-examination certificate or an additional approval as the case may be does not comply with the provisions of the TTE Directive, it shall withdraw the certificate or approval.

Conformity to type

The conformity to type part of the procedure

24.  Regulations 25 and 26 below shall have effect in relation to a manufacturer or his authorised representative who chooses to carry out the EC declaration of conformity to type procedure pursuant to the conformity to type part of the procedure, that is to say, that part of the procedure provided for in Annex II of the TTE Directive whereby the manufacturer, or his authorised representative ensures and declares pursuant to that Annex that the applicable terminal equipment concerned is in conformity with the type as described in the EC type-examination certificate, or with the modification described in the additional approval, as the case may be, and satisfies the requirements of the TTE Directive which apply to it.

Manufacturer’s duty

25.  In producing applicable terminal equipment to an approved type, the manufacturer shall take all measures necessary to ensure that the manufacturing process assures compliance of the manufactured products with the type as described in the EC type-examination certificate and additional approval where appropriate and with the requirements of the TTE Directive that apply to them.

Product check procedure

26.—(1) The manufacturer shall choose a notified body to carry out random product checks as provided for in the procedure set out in paragraph (2) below (“the product check procedure”), and shall permit that notified body to carry out that procedure, and without prejudice to the generality of the foregoing, he shall—

(a) allow the notified body access for the purpose of taking samples of the final products;

(b) provide the notified body with such access, information, facilities and assistance as it may reasonably require in carrying out that procedure.

(2) The conformity to type product check procedure shall consist of—

(a) the notified body carrying out, or having carried out by a recognised test laboratory, product checks at random intervals;

(b) the taking of an adequate sample of the final products, by the notified body or on its behalf, and the notified body carrying out or having carried out by a recognised test laboratory an examination and appropriate tests to check the conformity of products with the relevant requirements of the TTE Directive.

(3) Where it appears to a United Kingdom notified body acting pursuant to paragraph (1) above that one or more of the products checked do not fulfil the relevant conditions, it shall report the matter—

(a) to the notified body (if not itself) which issued the EC type-examination certificate or additional approval, as the case may be;

(b) where the products are manufactured, or the body is aware that products manufactured in accordance with the type or modification concerned are to be or have been supplied or put into service or connected to the public telecommunications network in the United Kingdom, to the enforcement authority;

(c) where the products are manufactured, or the body is aware that products manufactured in accordance with the type or modification concerned are to be or have been supplied or put into service or connected to a public telecommunications network in a member State other than the United Kingdom, to the appropriate authorities in that member State; or

(d) where the body is aware that products manufactured in accordance with the type or modification concerned are to be or have been connected to a public telecommunications network in the United Kingdom or another member State, to the operator thereof.

(4) For the avoidance of doubt, it is hereby declared that the notified body referred to in paragraph (1) above need not be the same notified body as the one which granted the EC type-examination certificate or additional approval, as the case may be.

(5) If the manufacturer fails to comply with his obligations under paragraph (1)(a) and (b) above—

(a) where that United Kingdom notified body is the body which granted the EC type-examination certificate, it shall suspend the certificate; and

(b) where another notified body granted the EC type-examination certificate, it shall report the matter to that other body for appropriate action and, where that other body is a United Kingdom notified body, that other body shall suspend the certificate;

and a certificate suspended pursuant to this paragraph shall remain suspended until the manufacturer complies with the requirements of paragraph (1)(a) and (b) above.

Production quality assurance

The production quality assurance part of the procedure

27.  Regulations 28 to 35 below shall have effect in relation to a manufacturer who chooses to carry out the EC declaration of conformity to type procedure pursuant to the production quality assurance part of the procedure, that is to say, that part of the procedure provided for in Annex III of the TTE Directive whereby the manufacturer who operates a production quality assurance approved quality system ensures and declares pursuant to that Annex that the applicable terminal equipment concerned fulfils the relevant conditions.

Manufacturer’s duty

28.  The manufacturer shall operate a production quality assurance approved quality system.

Application for approval of a production quality assurance quality system

29.—(1) The manufacturer shall lodge an application for approval of his quality system with a notified body of his choice, for the products concerned.

(2) An application for approval of a quality system made to a United Kingdom notified body shall include—

(a) all relevant information for the product category envisaged;

(b) the documentation concerning the quality system; and

(c) if applicable, the technical documentation of the approved type and a copy of the EC type-examination certificate, and, where the application relates to the production of a modification, the additional technical documentation and the additional approval.

Requirements for the approval of quality systems by a United Kingdom notified body

30.  A United Kingdom notified body shall not approve a quality system unless—

(a) it ensures that products fulfil the relevant conditions;

(b) all the elements, requirements and provisions of the quality system are documented in a systematic and orderly manner in the form of written policies, procedures and instructions;

(c) the quality system documentation permits a consistent interpretation of the quality programmes, plans, manuals and records;

(d) the quality system documentation contains an adequate description of—

(i) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

(ii) the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(iii) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

(iv) the quality records; and

(v) the means to monitor the achievement of the required product quality and the effective operation of the quality system.

Assessment of quality systems by a United Kingdom notified body

31.—(1) A United Kingdom notified body with which an application has been lodged for the approval of a quality system shall assess the quality system to determine whether it satisfies the requirements of regulation 30 above, and the following provisions of this regulation shall have effect in relation to the conduct of the assessment.

(2) The United Kingdom notified body shall presume conformity with those requirements in respect of quality systems that implement a standard which is for the time being a relevant harmonized standard for the purposes of point 3.3 of Annex III of the TTE Directive(1) .

(3) The auditing team shall have at least one member with experience of evaluation in the product technology concerned.

(4) The evaluation procedure shall include an inspection visit to the manufacturer’s premises concerned.

(5) Subject to regulation 54 below, the United Kingdom notified body shall inform the manufacturer by notice in writing of the decision on whether to approve the quality system, and such notice shall contain the conclusions of the examination and the reasoned assessment decision.

Manufacturer’s undertaking

32.  Where a United Kingdom notified body informs the manufacturer pursuant to regulation 31(5) above that it has decided to approve the quality system, the approval shall not have effect until the manufacturer has deposited with that body a written undertaking to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and effective.

Modifications to quality systems

33.—(1) Where a manufacturer intends to update a production quality assurance approved quality system approved by a United Kingdom notified body, the manufacturer or his authorised representative shall apply to that body for the approval of the quality system as modified in accordance with the proposed modifications.

(2) Subject to regulation 54 below, the United Kingdom notified body shall, on application made pursuant to paragraph (1) above, evaluate the proposed modifications and decide whether the amended quality system will satisfy the requirements of regulation 30 above or whether a re-assessment pursuant to regulation 31 would be required to evaluate the system as modified in accordance with the proposals.

(3) The United Kingdom notified body shall inform the manufacturer by notice in writing of the decision on whether to approve the proposed modifications to the quality system, and such notice shall contain the conclusions of the examination and the reasoned assessment decision.

(4) Where a United Kingdom notified body informs the manufacturer pursuant to paragraph (3) above that it has decided to approve the proposed modifications to an approved quality system—

(a) the approval of the quality system shall have effect as if the modifications were made; and

(b) the written undertaking referred to in regulation 32 shall have effect as if it were an undertaking to fulfil the obligations arising out of the quality system as approved as so modified and to uphold it as so modified so that it remains adequate and effective.

Surveillance procedure

34.—(1) The notified body shall carry out surveillance as provided for in the procedure set out in paragraph (2) below (“the production quality assurance surveillance procedure”) and the manufacturer shall permit that notified body to carry out that procedure, and, without prejudice to the generality of the foregoing, he shall—

(a) allow the notified body access for the purpose of inspection to the location of manufacture, inspection and testing, and storage;

(b) provide the notified body with such information (including the quality system documentation and the quality records), facilities and assistance as it may reasonably require in carrying out that procedure.

(2) The purpose of the production quality assurance surveillance procedure is to make sure that the manufacturer duly fulfils the obligations arising out of the production quality assurance approved quality system, and the procedure shall consist of—

(a) the carrying out by the notified body of audits at reasonable intervals to make sure that the manufacturer maintains and applies the approved quality system and the provision of an audit report to the manufacturer; and

(b) should the notified body consider it necessary, the paying of unexpected visits to the manufacturer, during which the notified body may carry out, or cause to be carried out, tests to verify that the quality system is functioning correctly, and, where such a visit has been paid, the provision of a visit report and a report upon any such tests.

(3) Where it appears to a United Kingdom notified body acting pursuant to paragraph (1) above that the manufacturer is not fulfilling his obligations under the production quality assurance approved quality system, it shall report the matter—

(a) to the notified body (if not itself) which issued the EC type-examination certificate or additional approval, as the case may be;

(b) where the products are manufactured, or the body is aware that products manufactured in accordance with the type or modification concerned are to be or have been supplied or put into service or connected to the public telecommunications network in the United Kingdom, to the enforcement authority;

(c) where the products are manufactured, or the body is aware that products manufactured in accordance with the type or modification concerned are to be or have been supplied or put into service or connected to a public telecommunications network in a member State other than the United Kingdom, to the appropriate authorities in that other member State;

(d) where the body is aware that products manufactured in accordance with the type or modification concerned are to be or have been connected to a public telecommunications network in the United Kingdom or another member State, to the operator thereof.

(4) If the manufacturer fails to comply with his obligations under paragraph (1)(a) and (b) above—

(a) the notified body shall suspend the approval, and where it granted the EC type examination certificate, it shall suspend that certificate; and

(b) where another notified body granted the EC type-examination certificate, it shall report the matter to that other body for appropriate action and, where that other body is a United Kingdom notified body, that other body shall suspend the certificate;

and a certificate or approval suspended pursuant to this paragraph shall remain suspended until the manufacturer complies with the requirements of paragraph (1)(a) and (b) above.

Withdrawal and compulsory modification of approved quality systems

35.  Subject to regulation 54 below, where a United Kingdom notified body which approved a production quality assurance approved quality system is satisfied that—

(a) the manufacturer is not fulfilling his obligations under the system or that one or more products to which the system relates do not fulfil the relevant conditions, that body may withdraw the approval;

(b) the system does not ensure, when operated as intended, that products to which it relates fulfil the relevant conditions, that body shall withdraw the approval;

(c) in order for the system to ensure that products to which it relates fulfil the relevant conditions, it is necessary to modify the system, that body shall require the manufacturer to modify the system accordingly, and the approval of the system shall have effect in accordance with the modification.

Final provisions

EC declaration of conformity to type where equipment submitted for approval in the United Kingdom

36.  Where applicable terminal equipment is submitted for approval in accordance with a type or modification in the United Kingdom, the manufacturer shall draw up the EC declaration of conformity to type in English, or another language acceptable to the notified body concerned.

Interpretation

37.  In this Part—

• “quality records” include inspection reports and test data, calibration data and qualification reports of the personnel concerned;

• “relevant conditions” are that the products conform with the type or modification described in the EC type-examination certificate or additional approval as the case may be and with other relevant requirements of the TTE Directive; and

• “specimen” in relation to a type or a modification means a specimen of the production envisaged in relation thereto.

(1)

EN 29002 supplemented if necessary to take into account the specific nature of the procedure for which it is implemented.