PART IIIGENERAL REQUIREMENTS
General duty for supply
28. No person shall supply relevant apparatus unless the requirements of regulation 30 below are complied with in relation thereto.
General duty for taking into service
29. No person shall take into service relevant apparatus unless that apparatus conforms with the protection requirements.
Requirements for supply
30. The requirements of this regulation are that—
(a)the relevant apparatus conforms with the protection requirements;
(b)the conformity assessment requirements have been complied with;
(c)the CE mark has been properly affixed by the manufacturer or his authorised representative in relation to the relevant apparatus in accordance with regulation 33 below; and
(d)the manufacturer or his authorised representative has properly issued an EC declaration of conformity in respect of the relevant apparatus in accordance with the requirements of regulation 34 below.
Conformity assessment requirements—the three routes to compliance
31. The conformity assessment requirements are that—
(a)in the case of relevant apparatus other than radiocommunication transmission apparatus, the requirements of—
(i)Part IV (in these Regulations referred to as “the standards route to compliance ”); or
(ii)Part V (in these Regulations referred to as “the technical construction file route to compliance ”)
of these Regulations are complied with; and
(b)in the case of radiocommunication transmission apparatus, the requirements of Part VI (in these Regulations referred to as “the EC type-examination route to compliance ”) of these Regulations are complied with.
Presumption of conformity
32. Where in relation to any relevant apparatus—
(a)such apparatus conforms to the applicable EMC standard, or all applicable EMC standards, which make provision for that apparatus; or
(b)the conformity assessment requirements are complied with pursuant to the technical construction file route to compliance,
there shall be a presumption (“the presumption of conformity ”) that, until the contrary is proved, that relevant apparatus complies with the protection requirements.
The CE mark
33.—(1) For the purposes of these Regulations, the CE mark shall be regarded as properly affixed in relation to relevant apparatus if the requirements of paragraphs (2) to (4) below are complied with.
(2) The CE mark shall be affixed in relation to any relevant apparatus by being affixed to one of the following—
(a)the apparatus; or
(b)the apparatus'—
(i)packaging;
(ii)instructions for use; or
(iii)guarantee certificate.
(3) Where the apparatus in relation to which the mark is affixed is radiocommunication transmission apparatus, the CE mark shall be followed by the distinctive letters used by the notified body which issued the EC type-examination certificate in respect of the apparatus with which the first-mentioned apparatus conforms.
(4) Where the apparatus is the subject of Community Directives other than the EMC Directive providing for the affixing of a mark consisting of or including the symbol “CE ”, the CE mark may only be affixed in relation thereto for the purposes of these Regulations if the apparatus conforms with the relevant requirements of those other Directives.
(5) No person shall affix the CE mark, or any other inscription liable to be confused therewith, in relation to any relevant apparatus, unless—
(a)the apparatus complies with the protection requirements; and
(b)the conformity assessment procedures have been complied with.
(6) No person shall affix the CE mark, or any other inscription liable to be confused therewith, in relation to any electrical apparatus other than relevant apparatus: provided that nothing in this paragraph shall prohibit the affixing of the CE mark to any electrical apparatus pursuant to any Community right or obligation other than the EMC Directive.
(7) In these Regulations, “CE mark ” means a mark consisting of the symbol “CE ” set out in the form shown in Schedule 4 hereto.
EC declaration of conformity
34.—(1) For the purposes of these Regulations, an EC declaration of conformity is a declaration which indicates that apparatus conforms with the protection requirements of the EMC Directive (howsoever expressed).
(2) For the purposes of these Regulations, an EC declaration of conformity shall be regarded as properly issued in relation to relevant apparatus if the following requirements are complied with —
(a)the apparatus conforms with the protection requirements;
(b)the conformity assessment requirements are complied with;
(c)in the case of a declaration issued in the United Kingdom—
(i)in the case of a declaration issued pursuant to the standards route to compliance, it complies with the requirements of regulation 40 below;
(ii)in the case of a declaration issued pursuant to the technical construction file route to compliance, it complies with the requirements of regulation 57 below;
(iii)in the case of a declaration issued pursuant to the EC type-examination route to compliance, it complies with the requirements of regulation 70 below;
(d)in the case of a declaration issued other than in the United Kingdom, the declaration is issued by the manufacturer or his authorised representative and contains the following —
(i)a description of the apparatus to which it refers;
(ii)reference to the specifications or harmonised standards or both under which conformity is declared, and where appropriate, to the national measures or recognised national standards or both, as the case may be, implemented to ensure the conformity of the apparatus with the provisions of the EMC Directive;
(iii)identification of the signatory empowered to bind the manufacturer or his authorised representative; and
(iv)where appropriate, reference to the EC type-examination certificate issued by a notified body.
(3) No person shall (in the United Kingdom) issue an EC declaration of conformity in relation to relevant apparatus unless—
(a)the apparatus to which it relates conforms with the protection requirements;
(b)the conformity assessment requirements have been complied with; and
(c)the requirements of paragraph (2)(c) above are complied with.
(4) No person shall (in the United Kingdom) issue an EC declaration of conformity in relation to any electrical apparatus other than relevant apparatus.
Retention of documentation
35.—(1) A responsible person shall hold an EC declaration of conformity in relation to relevant apparatus at the disposal of the Secretary of State for ten years beginning with the date on which the latest item of relevant apparatus to be supplied in the Community to which the declaration relates was so supplied.
(2) Where the EC declaration of conformity is made pursuant to Part V or VI of these Regulations, the responsible person shall hold the technical construction file, or EC type-examination certificate, as the case may be, at the disposal of the Secretary of State for ten years beginning with the date on which the latest item of relevant apparatus to be supplied in the Community to which the technical construction file or EC type-examination certificate relates was so supplied.
(3) Any documentation to be retained by the responsible person pursuant to the requirements of paragraphs (1) and (2) above may be kept by recording the matters in question in a manner other than material form provided, however, adequate precautions shall be taken for guarding against falsification.
(4) The power conferred on a responsible person in paragraph (3) above includes power to keep the documentation by recording those matters otherwise than in legible form, so long as the recording is capable of being reproduced in a legible form.
(5) If the responsible person records the documentation in question otherwise than in a legible form, any duty imposed on him by these Regulations to allow inspection of, or to furnish a copy of, the documentation or any part of it is to be treated as a duty to allow inspection of, or to furnish, a reproduction of the document or of the relevant part of it in legible form.