PART IIIGENERAL REQUIREMENTS
Conformity assessment procedures10
1
Subject to paragraphs (4) and (5) below, for the purposes of regulation 6(2)(b) above, the appropriate conformity assessment procedure shall—
a
in the case of equipment and, where necessary, a device, be determined in accordance with paragraph (3) below by reference to the equipment-group and equipment-category of that particular equipment or, as the case may be, device; and
b
in the case of an autonomous protective system, be the procedure set out in paragraph (3)(a) or (d) below.
2
For the purposes of regulation 8(2)(a) above, in the case of a component the appropriate conformity assessment procedure shall be the procedure set out in paragraph (3) below, which relates to the equipment or protective system into which that component is to be incorporated, with the exception of the affixing of the CE marking.
3
The procedures referred to in paragraphs (1) and (2) above are as follows:
a
without prejudice to sub-paragraph (d) below, in the case of equipment-group I and II, equipment-category M 1 and 1, the manufacturer or his authorized representative established in the Community must, in order to affix the CE marking, follow the EC type-examination procedure (referred to in Annex III of the ATEX Directive, which is set out in Schedule 6 hereto), in conjunction with:
i
the procedure relating to production quality assurance (referred to in Annex IV of the ATEX Directive, which is set out in Schedule 7 hereto); or
ii
the procedure relating to product verification (referred to in Annex V of the ATEX Directive, which is set out in Schedule 8 hereto);
b
without prejudice to sub-paragraph (d) below, in the case of equipment-group I and II, equipment-category M 2 and 2,
i
in the case of internal combustion engines and electrical equipment in these groups and categories, the manufacturer or his authorized representative established in the Community shall, in order to affix the CE marking, follow the EC-type examination procedure (referred to in Annex III of the ATEX Directive, which is set out in Schedule 6 hereto), in conjunction with:
aa
the procedure relating to conformity to type referred to in Annex VI of the ATEX Directive (which is set out in Schedule 9 hereto); or
bb
the procedure relating to product quality assurance referred to in Annex VII of the ATEX Directive (which is set out in Schedule 10 hereto); and
ii
in the case of other equipment in these groups and categories, the manufacturer or his authorized representative established in the Community must, in order to affix the CE mark, follow the procedure relating to internal control of production (referred to in Annex VIII of the ATEX Directive, which is set out in Schedule 11 hereto) and communicate the dossier, provided for in paragraph 3 of Annex VIII, to a notified body, which shall acknowledge receipt of it as soon as possible and shall retain it;
c
without prejudice to sub-paragraph (d) below, in the case of equipment-group II, equipment-category 3, the manufacturer or his authorized representative established in the Community must, in order to affix the CE marking, follow the procedure relating to internal control of production referred to in Annex VIII of the ATEX Directive (which is set out in Schedule 11 hereto); or
d
in the case of equipment-groups I and II, as an alternative to the procedures referred to in sub-paragraphs (a), (b) and (c) above, the manufacturer or his authorized representative established in the Community may, in order to affix the CE marking, follow the procedure relating to CE unit verification (referred to in Annex IX of the ATEX Directive, which is set out in Schedule 12 hereto).
4
In the case of equipment, protective systems or devices, the manufacturer or his authorized representative established in the Community may, in order to affix the CE marking, follow the procedure relating to internal control of production (referred to in Annex VIII of the ATEX Directive, which is set out in Schedule 11 hereto) with regard to the safety aspects referred to in point 1.2.7 of Annex II of the ATEX Directive (which is set out in Schedule 3 hereto).
5
Notwithstanding the previous paragraphs of this regulation, the Secretary of State may, on a duly justified request, authorize the placing on the market and putting into service of equipment, protective systems and individual devices refered to in Article 1(2) in respect of which the procedures referred to in the previous paragraphs have not been applied and the use of which is in the interests of protection.
6
Documents and correspondence relating to the procedures referred to in the above-men tioned paragraphs shall be drawn up in one of the official languages of the member States in which those procedures are being applied or in a language accepted by the notified body to which an application is made pursuant to one of those procedures.