The Medical Devices Regulations 2002

[F1 3.   In Annex 2— E+W+S

(a) for the heading substitute “Declaration of conformity”;

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

(c) for “this Directive” each time it occurs substitute “the Regulations”;

(d) in Section 1, for “EC Surveillance” substitute “Surveillance”;

(e) in Section 2—

(i) for “his authorized representative” substitute “their UK responsible person”;

(ii) omit “established within the Community”;

(iii) for “CE marking” [F2 , in both places it occurs,] substitute “UK marking”;

[F3 (iv) for “Article 12” substitute “regulation 24”;]

(f) in Section 3.1—

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

(ii) in the fifth indent, for “competent authorities” substitute “Secretary of State”;

[F4 (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”;]

[F5 (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”;]

(i) in Section 3.4, in the second paragraph, for the first sentence substitute—

“The proposed modifications shall be evaluated by the approved body so as to verify whether the quality system so modified would still meet the requirements referred to in Section 3.2.”;

(j) in Section 4.2 in the second indent for “Article 5” substitute “regulation 3A of the Regulations”;

(k) for Section 4.3 substitute—

“4.3.   The approved body must examine the application and, where the product complies with the relevant provisions of the Regulations, shall issue the applicant with a design certificate. The approved body may require the application to be supplemented by further tests or proof so that compliance with the requirements of the Regulations may be evaluated. The certificate shall contain conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product.

In the case of devices referred to in Annex 1, Section 10, second paragraph, the approved body shall, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.

In the case of devices referred to in Annex I, Section 10, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.”;

(l) in Section 4.4, for each reference to “EC design” substitute “design”;

(m) in Section 6.1—

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

(ii) for “his authorised representative” substitute “their UK responsible person”;

(n) for Section 6.2 substitute—

“6.2.   On request, an approved body must make available to other approved bodies and to the Secretary of State all relevant information on approvals of quality systems, issued, refused or withdrawn.”;

(o) for Section 7 substitute—

“7.   Application to the devices incorporating a human blood derivative:

Upon completing the manufacture of each batch of devices incorporating a human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by 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)

F2 Words in Sch. 2A para. 3(e)(iii) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(c)(i)

F3 Sch. 2A para. 3(e)(iv) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(c)(ii)

F4 Sch. 2A para. 3(g) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(c)(iii)

F5 Sch. 2A para. 3(h) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(c)(iv)