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Paragraph 7 F1

In Annex 6—

(a)

in Section 1, for “authorised representative established within the Community” substitute “UK responsible person”;

(b)

in Section 3 for “the competent national authorities” substitute “the Secretary of State”;

(c)

in Section 3.1 for “this Directive” substitute “the Regulations”;

(d)

in Section 3.2 for the fourth indent substitute—

“–the results of the risk analysis and a list of the designated standards provided for in regulation 3A of the Regulations, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements where the standards in regulation 3A of the Regulations have not been applied,”;

(F2e)

omit Section 5.

Annotations

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)

F2

Sch. 2A para. 7(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(5) (with reg. 6)