Textual Amendments
F1Sch. 15 inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 28 para. 54 (with Sch. 28 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
1. Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer—
(a)fulfils the obligations set out in paragraphs 2, 5(1) and 6; and
(b)ensures and declares on the manufacturer's sole responsibility that the product concerned, which has been subject to the provisions of paragraph 3—
(i)is in conformity with the type described in the type examination certificate; and
(ii)meets the essential requirements that apply to it.
2. The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with—
(a)the approved type described in the type examination certificate; and
(b)the essential requirements that apply to it.
3.—(1) An approved body chosen by the manufacturer must carry out appropriate examinations and tests in order to check the conformity of the product with—
(a)the approved type described in the type examination certificate; and
(b)the essential requirements that apply to it.
(2) The examinations and tests to check the conformity of the products with the essential requirements that apply to it must be carried out, at the choice of the manufacturer, either by—
(a)examination and testing of every product as specified in paragraph 4; or
(b)examination and testing of the products on a statistical basis as specified in paragraph 5.
4.—(1) All products must be individually examined, and appropriate tests set out in the relevant designated standard or technical specifications or equivalent tests must be carried out in order to verify conformity with the approved type described in the type examination certificate and with the essential requirements that apply to it. In the absence of such a designated standard, the approved body concerned must decide on the appropriate tests to be carried out.
(2) The approved body must issue a certificate of conformity in respect of the examinations and tests carried out and must affix its identification number to each approved product or have it affixed under its responsibility.
(3) The manufacturer must keep the certificates of conformity at the disposal of the enforcing authority for 10 years after the product has been placed on the market.
5.—(1) The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced and must present the manufacturer's products for verification in the form of homogeneous lots.
(2) A random sample must be taken from each lot by the approved body. All products in a sample must be individually examined, and appropriate tests set out in the relevant designated standard or technical specification or equivalent tests must be carried out in order to ensure their conformity with the essential requirements that apply to them and to determine whether the lot is to be accepted or rejected. In the absence of such a designated standard, the approved body concerned must decide on the appropriate tests to be carried out.
(3) If a lot is accepted, all products of the lot must be considered approved, except for those products from the sample that have been found not to satisfy the tests.
(4) The approved body must issue a certificate of conformity in respect of the examinations and tests carried out and must affix its identification number to each approved product or have it affixed under its responsibility.
(5) The manufacturer must keep the certificates of conformity at the disposal of the enforcing authority for 10 years after the product has been placed on the market.
(6) If a lot is rejected, the approved body or, if the approved body fails to do so, the Secretary of State must take appropriate measures to prevent that lot being placed on the market. In the event of the frequent rejection of lots, the approved body may suspend the statistical verification and take appropriate measures.
6.—(1) The manufacturer must affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3, the approved body's identification number to each individual product that is in conformity with the approved type described in the type examination certificate and meets the essential requirements that apply to it.
(2) The manufacturer must draw up a declaration of conformity for each product model and keep it at the disposal of the enforcing authority for 10 years after the product has been placed on the market. The declaration of conformity must identify the product model for which it has been drawn up.
(3) The manufacturer must make a copy of the declaration of conformity available to the enforcing authority upon request.
(4) If the approved body referred to in paragraph 3 agrees and under its responsibility, the manufacturer may also affix the approved body's identification number to the product.
7. If the approved body agrees and under its responsibility, the manufacturer may affix the approved body's identification number to the product during the manufacturing process.
8. Where the manufacturer appoints an authorised representative (see regulation 39), the obligations in paragraphs 2 and 5(1) must not form part of the authorised representative's mandate.]