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

21.  In Schedule 2A(1) (modification of Annexes to Directives 90/385, 93/42 and 98/79)—

(a) in paragraph 2, before sub-paragraph (a), insert—

“(za) in Section 2, for “the functions referred to in Article 1(2)(a)” substitute “the purposes referred to in the definition of a medical device in regulation 2(1) of the Regulations”;

(b) in paragraph 2(c), after paragraph (ii), insert—

“(iii) for “a device within the meaning of Article 1(4a)” substitute “a stable derivatives device”;

(c) in paragraph 3—

(i) in sub-paragraph (e)(iii), after ““CE marking”” insert “, in both places it occurs,”,

(ii) in sub-paragraph (e), after paragraph (iii), insert—

“(iv) for “Article 12” substitute “regulation 24”;”,

(iii) for sub-paragraph (g), substitute—

“(g) in Section 3.2—

(i) in the first paragraph, omit “of this Directive”;

(ii) in point (c), for “Article 5” substitute “regulation 3A of the Regulations”;”,

(iv) for sub-paragraph (h) substitute—

“(h) in Section 3.3—

(i) for the first sentence substitute—

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

(ii) in the second sentence for “harmonized” substitute “designated”;”;

(d) for paragraph 8, substitute—

“8.   In Annex 7—

(a) in Section 1.1 for “harmonised” substitute “designated”;

(b) in Section 2.3.5 for “all competent authorities of the Member States in which the clinical investigation is being performed” substitute “the Secretary of State”;”;

(e) in paragraph 9, after sub-paragraph (a), insert—

“(aa) in Section 1 for “authorized representative” substitute “UK responsible person”;”;

(f) in paragraph 13—

(i) after sub-paragraph (d) insert—

“(da) in Section 3.1—

(i) in the first sentence, for “a notified body” substitute “an approved body”;

(ii) for “other notified body” substitute “other approved body”;

(iii) for “the competent authorities” substitute “the Secretary of State”;”,;

(g) in paragraph 15—

(i) after sub-paragraph (i) insert—

“(zj) in Section 8.2 for “notified body” substitute “approved body”;”;

(ii) in sub-paragraph (j), after paragraph (i), insert—

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

(h) in paragraph 17—

(i) in sub-paragraph (e), after paragraph (ii), insert—

“(iii) for “competent authorities” substitute “Secretary of State”;”;

(ii) after sub-paragraph (g), insert—

“(ga) in Section 4.4 for “Article 5” substitute “regulation 3A of the Regulations”;”;

(iii) after sub-paragraph (j), insert—

“(k) in Section 6.4 for “notified body” substitute “approved body”.”;

(i) in paragraph 22, in sub-paragraph (d), for “the Secretary of State” substitute “Secretary of State”.

(1)

Inserted by S.I. 2019/791 (as amended by S.I. 2020/1478).