43. This Part shall have effect for the purposes of providing for—
(a)the circumstances and manner in which the conformity assessment requirements may be complied with pursuant to the technical construction file route to compliance; and
(b)the appointment of United Kingdom competent bodies to exercise functions in relation thereto, and matters incidental to such appointment and exercise.
44.—(1) Subject to paragraph (2) below, the conformity assessment requirements may be complied with pursuant to the technical construction file route to compliance where—
(a)there are applicable EMC standards which make complete provision in respect of the apparatus, but the manufacturer has chosen not to apply all or any of those standards either as regards the whole or part thereof;
(b)there is no applicable EMC standard; or
(c)there are applicable EMC standards and the manufacturer has applied all or any of them as regards the whole or part thereof, but they do not make complete provision in respect of the apparatus.
(2) The technical construction file route to compliance shall not apply in respect of radiocommunication transmission apparatus.
45.—(1) A technical construction file is a file which—
(a)describes the apparatus to which it relates;
(b)contains information about the design, manufacture and operation thereof;
(c)sets out the procedures used to ensure the conformity of the apparatus with the protection requirements in respect of the applicable EM characteristics of the apparatus in respect of which the manufacturer has not applied an applicable EMC standard; and
(d)includes a technical report or technical certificate.
(2) A technical construction file may be composed in relation to—
(a)a single item of apparatus;
(b)where a number of items are to be produced, a specimen representative of the production envisaged (a “representative”); or
(c)a number of items of apparatus or representatives of each such item or representative being variants of the same basic design (each such item or representative being referred to as a “variant”).
(3) Without prejudice to the generality of paragraph (1) above, a technical construction file composed in the United Kingdom shall—
(a)be in material form;
(b)be in—
(i)English where application for the technical report or technical certificate is made to a United Kingdom competent body; or
(ii)any official Community language acceptable to the competent body where such application is made to a competent body of another member State;
(c)give the name and address—
(i)of the responsible person;
(ii)where that person is not the manufacturer, of the manufacturer;
(d)contain such information as is sufficient, in all the circumstances of the case, to enable the enforcement authority to—
(i)identify the apparatus to which it relates; and
(ii)ascertain whether the apparatus to which it relates conforms with the protection requirements;
(e)state the numbers and titles of the applicable EMC standards, and any other standards, specifications or codes of practice, applied by the manufacturer; and
(f)contain particulars of the electromagnetic environment for which the apparatus is suitable.
46. The conformity assessment requirements are complied with in relation to relevant apparatus pursuant to the technical construction file route to compliance if the manufacturer or his authorised representative has composed a technical construction file in respect of the apparatus.
47. For the purposes of these Regulations, a competent body is a body responsible for issuing technical reports and technical certificates pursuant to Article 10.2 of the EMC Directive either for all descriptions of relevant apparatus (other than radiocommunication transmission apparatus) or for specific descriptions thereof, and which is for the time being—
(a)a United Kingdom competent body pursuant to appointment under regulation 48 below;
(b)a competent body of a member State other than the United Kingdom; or
(c)recognised for the purpose of carrying out those functions by inclusion in a mutual recognition agreement relating to the EMC Directive or a similar agreement (including a Protocol to the Europe Agreement, or other Agreement, on Conformity Assessment and Acceptance of Industrial Products) which has been concluded between the Community and a State other than an EEA State.