[F1Approval of conformity assessment bodiesE+W+S
44.—(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 apparatus 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 regulation “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.]
Extent Information
E1This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Pt. 4 substituted (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. 20 para. 28 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2, and The Product Safety and Metrology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/852), regs. 2(2), 4(2), Sch. 1 para. 1(i), (iv)); 2020 c. 1, Sch. 5 para. 1(1)
NotificationN.I.
44.—(1) The Secretary of State may notify to the European Commission and the other [F2relevant states] only those conformity assessment bodies that qualify for notification.
(2) A conformity assessment body qualifies for notification 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 a notified body and the 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 module or modules in respect of which the conformity assessment body claims to be competent; and
(iii)the apparatus for which the conformity assessment body claims to be competent; and either
(b)an accreditation certificate; or
(c)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the notified body requirements.
(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the notified 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 notified body requirements.
(6) When deciding whether to notify a conformity assessment body that qualifies for notification to the European Commission and the other [F2relevant states], 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) The Secretary of State must inform the European Commission of the United Kingdom's procedures for the assessment and notifications of conformity assessment bodies, and any changes to those procedures.
Textual Amendments
F2Words in reg. 44 substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 4(2)