The Medical Devices (Amendment) (EU Exit) Regulations 2021

15.  In Annex I (which relates to risk assessment, management and evaluation of notified bodies which have now become approved bodies)—

(a) in section 1.2, in the fifth paragraph, for “European or” to the end of that paragraph, substitute “international scientific committees or bodies.”;

(b) in section 1.2.5.2, in the second paragraph, omit “European or”;

(c) in section 2—

(i) for the heading substitute “EVALUATION BY APPROVED BODIES”,

(ii) for “notified bodies referred to in Article 4” substitute “approved bodies referred to in Article 4”;

(d) in section 2.1—

(i) for the heading substitute “Information of the Approved Body regarding changes and new information”,

(ii) for “notified body”, in both places it occurs, substitute “approved body”;

(e) in section 2.2—

(i) for “an EC”, in both places it occurs, substitute “a”,

(ii) for “Article 9(8) of Directive 90/385/EEC or Article 11(11) of Directive 93/42/EEC” substitute “regulation 18(3) or regulation 31(3) of the Medical Devices Regulations 2002”,

(iii) for “notified body” substitute “approved body”;

(f) in section 2.3—

(i) for “a notified body” substitute “an approved body”,

(ii) for “this notified body” substitute “this approved body”.