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21.—(1) EC type-examination is the procedure whereby an approved body ascertains and certifies that an example of relevant machinery satisfies those provisions of the Machinery Directive which apply to it.
(2) An application for EC type-examination by a responsible person (in this regulation referred to as the applicant) to a United Kingdom approved body shall—
(a)specify—
(i)the name and address of the applicant; and
(ii)the place of manufacture of the machinery to which the application relates; and
(b)be accompanied by—
(i)a technical file for the machinery as described in regulation 14(2) above; and
(ii)an example of the machinery or, where appropriate, a statement as to where such an example might be examined.
(3) The United Kingdom approved body to which such application is made shall satisfy itself that the technical file contains all the necessary information.
(4) The United Kingdom approved body shall also—
(a)examine and perform such tests as it considers appropriate on the example; and
(b)if satisfied that—
(i)the example has been manufactured in conformity with the technical file and may safely be used under its intended working conditions;
(ii)the standards or transposed harmonised standards, as the case may be, if used, have been properly applied; and
(iii)the example complies with the relevant essential health and safety requirements,
draw up and forward to the applicant an EC type-examination certificate which shall state the conclusions of the EC type-examination, indicate any conditions to which the issue of the certificate is subject and shall be accompanied by the descriptions and drawings necessary to identify the example to which the certificate relates.
(5) The United Kingdom approved body shall, if so requested, taking the necessary measures to guarantee confidentiality, supply to the Secretary of State a copy of the EC type-examination certificate, a copy of the technical file and copies of the reports on the examinations and tests that it has carried out in relation to that application.
(6) If the United Kingdom approved body is not satisfied that the requirements of paragraphs (3) and (4)(b) above are met and is minded to refuse to issue an EC typeexamination certificate, it shall—
(a)inform the applicant in writing of the reasons why it proposes to refuse to issue an EC type-examination certificate;
(b)give the applicant the opportunity, within a reasonable period, of making representations as to why it should not be refused; and
(c)if, after considering any representations made pursuant to sub-paragraph (b) above, it remains unsatisfied in respect of the requirements of paragraphs (3) and (4)(b) above, it shall—
(i)notify its decision in writing to the applicant stating the grounds on which the refusal is based; and
(ii)at the same time inform all other approved bodies of such decision.
(7) Where the United Kingdom approved body which has issued an EC type-examination certificate in respect of an example of relevant machinery to an applicant is notified, pursuant to regulation 16 above, by that person of a modification which he or, where that person is not the manufacturer, the manufacturer has made, or plans to make, to the relevant machinery to which that example relates, the United Kingdom approved body shall examine such modification and—
(a)if it is satisfied that the relevant machinery as modified does, or would, as the case may be, conform sufficiently with the example as to the matters referred to in paragraph (4)(b) above, it shall notify the applicant in writing that the EC type-examination certificate is or would be, as the case may be, valid in respect of the relevant machinery as modified for the purposes of issuing EC declarations of conformity in accordance with regulation 22(5) below; or
(b)if it is not so satisfied it shall notify the applicant in writing that the EC typeexamination certificate is not, or would not be, as the case may be, a valid certificate in respect of the relevant machinery as modified for the abovementioned purposes stating the grounds on which such decision was based.
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