The Medical Devices Regulations 2002

[F1 13.   In Annex II— E+W+S

(a) in the title omit “EC”;

(b) for each reference to “the notified body” substitute “the approved body”;

(c) in Section 1 omit “Community”;

(d) in Section 2—

(i) omit “EC”;

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

(iii) for “CE marking” substitute “UK marking”;

(iv) omit the words “in accordance with Article 17”;

[F2 (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”;]

(e) in Section 3.2—

(i) in the first paragraph for “this Directive” substitute “the Regulations”

(ii) in point (c)—

(aa) for “Article 5” substitute “regulation 3A of the Regulations”;

(bb) for “Commission Directive 2003/32/EC” substitute “Commission Regulation 722/2012”;

(f) for Section 3.3 substitute—

“3.3.   The approved body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant designated standards conform to these requirements.

The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product concerned, an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes.

The decision must be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.”.

(g) for Section 3.4 substitute—

“3.4.   The manufacturer must inform the approved body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The approved body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.”;

(h) in Section 4.2, for “this Directive” substitute “the Regulations”;

(i) 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, must 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 requirement of the Regulations may be evaluated. The certificate must 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 7.4, second paragraph, the approved body must, 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 must 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 7.4, 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 must 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.”;

(j) in Section 4.4, omit each reference to “EC”;

(k) in Section 6.1—

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

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

(l) in Section 7.1 for “Article 11(2) and (3)” substitute “regulation 13(2) and (3) of the Regulations”;

(m) in Section 7.2 omit “for compliance with the provisions of this Directive”;

(n) in Section 7.3 omit “for compliance with the provisions of this Directive”;

(o) in Section 7.4 —

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

(ii) for “the competent authority” substitute “the Secretary of State”;

(p) for Section 8, substitute—

“8.   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 Sch. 2A para. 13(da) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(f)(i)