SCHEDULE 3Operational obligations of F8approved bodies
Word in Sch. 3 heading substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 39(b) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
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F9An approved body must carry out conformity assessments in accordance with the relevant conformity assessment procedures.
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F9An approved body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens on economic operators.
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F9An approved body must perform its activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
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F9An approved body must respect the degree of rigour and the level of protection required to ensure that the product is in conformity with the requirements of these Regulations.
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Where F9an approved body finds that essential health and safety requirements or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it must require the manufacturer to take appropriate corrective measures and must not issue a certificate of conformity or grant an approval.
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Where, in the course of the monitoring of conformity following the issue of a certificate or grant of an approval, F9an approved body finds that a product is no longer in conformity with the essential health and safety requirements, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the certificate of conformity or approval (if necessary).
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Paragraph 9 applies where F9an approved body is minded to—
a
refuse to issue a certificate of conformity or grant an approval;
b
restrict, suspend or withdraw a certificate of conformity or approval.
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Where this paragraph applies, the F2approved body must—
a
give the person applying for the certificate or approval, or the person to whom the certificate or approval was given, a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect;
b
give the person applying for the certificate or approval, or the person to whom the certificate or approval was given, an opportunity to make representations within a reasonable period from the date of the notice; and
c
take account of any such representations before taking its decision.
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F9An approved body must inform the Secretary of State of—
a
any refusal, restriction, suspension or withdrawal of a certificate of conformity or approval;
b
any circumstances affecting the scope of, or conditions for, notification under F3regulation 43 (approval of conformity assessment bodies);
c
any request for information which it has received from the market surveillance authority regarding conformity assessment activities; and
d
on request, any conformity assessment activities performed within the scope of its F4approval under regulation 43 and any other activity performed, including cross-border activities and subcontracting.
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F9An approved body must make provision in its contracts with its clients enabling such clients to appeal against a decision—
a
to refuse to issue a certificate of conformity or grant an approval; or
b
to restrict, suspend or withdraw a certificate of conformity or approval.
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F9An approved body must—
a
acknowledge receipt of the technical documentation provided by the manufacturer in accordance with regulation 39(1)(b)(ii)(bb) (conformity assessment procedures) as soon as possible; and
b
retain the technical documentation referred to in sub-paragraph (a).
Words in Sch. 3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 39(a) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)