Regulation 43 Devices for performance evaluationE1

England, Wales and Scotland

No person shall supply a device for performance evaluation (if that supply is also a making available of the device) unless the manufacturer or F1their UK responsible person—

(a)

has drawn up a statement containing the information required by Section 2 of Annex VIII and keeps that statement available for the Secretary of State for a minimum period of five years after the end of the performance evaluation;

(b)

ensures that—

(i)

the device conforms with the documentation mentioned in the said section 2, and

(ii)

the relevant requirements of F2these Regulations are complied with as respects that device; and

(c)

undertakes to keep available, and keeps available, for the Secretary of State, for a minimum period of five years after the end of the performance evaluation, documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations.

Annotations

Textual amendments

F1: Words in reg. 43 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(8)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 44); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in reg. 43(b)(ii) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(8)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 44); 2020 c. 1, Sch. 5 para. 1(1)

Extent

E1: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only