The Medical Devices Regulations 2002

[F1 16.   In Annex V— E+W+S

(a) for “notified body” each time it occurs substitute “approved body”;

(b) omit “EC” each time it occurs, including in the title;

(c) in Section 1, omit “Community”;

(d) in Section 2—

(i) for “this Directive” substitute “the Regulations”;

(ii) for “CE marking in accordance with Article 17” substitute “UK marking”;

(e) in the eighth indent of Section 3.1, for “competent authorities” substitute “Secretary of State”;

(f) in Section 3.3, for the first sentence substitute—

“The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2.”;

(g) in Section 3.4, for the last two paragraphs substitute—

“The proposed changes must be evaluated by the approved body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.”;

(h) in Section 5.1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “national authorities” substitute “Secretary of State”;

(i) in Section 6 for each reference to “this Directive” substitute “the Regulations”;

(j) in Section 6.3, for “competent authority” substitute “Secretary of State”;

(k) in Section 7—

(i) for the words “referred to in Article 1(4a)” substitute “which incorporate a substance derived from human blood or human plasma”;

(ii) for the words from “a State laboratory” to the end of that Section, substitute “a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.]

Textual Amendments

F1 Sch. 2A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 12 (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 56, 57); 2020 c. 1, Sch. 5 para. 1(1)