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Regulation (EU) 2016/425 of the European Parliament and of the CouncilShow full title
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)
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[F1Article 21U.K.Approval of conformity assessment bodies
1.The Secretary of State may approve only those conformity assessment bodies that qualify for approval.
2.A conformity assessment body qualifies for approval if the first and second conditions below are met.
3.The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—
(a)a description of—
(i)the conformity assessment activities that the conformity assessment body intends to carry out;
(ii)the conformity assessment procedure in respect of which the conformity assessment body claims to be competent;
(iii)the category of PPE in respect of which the conformity assessment body claims to be competent; and
(b)either—
(i)an accreditation certificate; or
(ii)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements.
4.The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.
5.For the purposes of paragraph 4, the Secretary of State may accept an accreditation certificate provided in accordance with paragraph 3(b), as sufficient evidence that the conformity assessment body meets the approved body requirements.
6.When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may—
(a)have regard to any other matter which appears to the Secretary of State to be relevant; and
(b)set conditions that the conformity assessment body must meet.
7.For the purposes of this Article, “accreditation certificate” means a certificate issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.]
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