[F121.—(1) A manufacturer must—U.K.
(a)fulfil the obligations arising out of the quality system as approved and maintain it in an adequate and efficient state; and
(b)keep the approved body that has approved the quality system informed of any intended change to the quality system.
(2) Where the approved body is notified by a manufacturer of any proposed change to the quality system the approved body must—
(a)evaluate such proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 19 or whether a reassessment is necessary; and
(b)notify the manufacturer of its decision and, that notification must contain the conclusions of the examination and a reasoned assessment of the decision.]
Textual Amendments
F1Schs. 17, 18 inserted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 16 para. 35 (with Sch. 16 para. 29) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)