The Medical Devices Regulations 2002

[F1 PART 3 E+W+S Modification of Annexes to Directive 98/79

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)

24.— (1) The Annexes to Directive 98/79 are modified so that they read as if amended by paragraphs 25 to 33. E+W+S

(2) In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002.

25.   In Annex 1— E+W+S

(a) in Section 3 in part A, for “Article 1(2)(b)” substitute “regulation 2(1) of the Regulations”;

(b) in Section 4.2 in part B, for “Council Directive 80/181/EEC of 20th December 1979” substitute “the Units of Measurement Regulations 1986”;

(c) in Section 8.1 in part B, omit the words from “The decision whether” to the end;

(d) in Section 8.2 in part B, for “harmonised standards” substitute “designated standards”;

(e) in Section 8.3 in part B —

(i) in the first sentence omit “of Directive 67/548/EEC and Directive 88/379/EEC”;

(ii) in the second sentence omit “by those Directives”;

(iii) omit the words from “The provisions of” to the end;

(f) in Section 8.4 in point (a), for the sentence beginning “For devices imported”, substitute—

“Where the manufacturer does not have a registered place of business in the United Kingdom the label, the outer packaging or instructions for use shall contain in addition the name and address of the UK responsible person.”.

26.   In Annex III— E+W+S

(a) in the title and in Section 1, omit “EC”;

(b) in Section 1—

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

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

(iii) for “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”;

(c) in Section 3, for “the Directive” in both places substitute “the Regulations”;

(d) in Section 3, in the sixth indent, for “Article 5” in both places substitute “regulation 3A of the Regulations”;

(e) in Section 5, for “competent authorities” substitute “Secretary of State”;

(f) in Section 6, for “a notified body” substitute “an approved body”;

(g) in Section 6.2—

(i) for “notified body”, both times those words occur, substitute “approved body”;

(ii) in the first sentence, for “this Directive” substitute “the Regulations”;

(iii) in the second sentence omit “of the Directive”;

(iv) for “an EC” substitute “a” ;

(h) in Section 6.3—

(i) for “notified body” in both places substitute “approved body”;

(ii) omit each reference to “EC”;

(iii) for “the Directive” substitute “the Regulations”.

27.   In Annex IV— E+W+S

(a) in the title, omit “EC”;

(b) for each reference to “this Directive” and “the Directive” substitute “the Regulations”;

(c) in Section 2, for “CE marking” substitute “UK marking”;

(d) in Section 3.1—

(i) for “of his quality system with a notified body” substitute “of its quality system with an approved body”;

(ii) in the third indent for “notified body” substitute “approved body”;

(e) in Section 3.3 for the first paragraph substitute—

“The quality system must be audited by the approved body 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 the requirements.”;

(f) in Section 3.4, in both paragraphs, for “notified body” substitute “approved body”;

(g) in Section 4.1 for “notified body” substitute “approved body”;

(h) in Section 4.3—

(i) for “notified body” both times those words occur substitute “approved body”;

(ii) for “an EC” substitute “a”;

(i) in Section 4.4—

(i) for “notified body” both times those words occur substitute “approved body”;

(ii) omit each reference to “EC”;

(j) in Section 4.5, for “notified body” both times those words occur substitute “approved body”;

(k) in Sections 5 and 6 for “notified body” each time those words occur substitute “approved body”.

28.   In Annex V— E+W+S

(a) in the title, omit “EC” ;

(b) in Section 1—

(i) for “EC type-examination” substitute “Type-examination”;

(ii) for “a notified body” substitute “an approved body”;

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

(c) in Section 2—

(i) in the first paragraph—

(aa ) omit “EC”;

(bb) for “his authorised representative” substitute “its UK responsible person”;

(cc) for “a notified body” substitute “an approved body”;

(ii) in the first indent—

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

(bb) for “the representative” substitute “the UK responsible person”;

(iii) in the second indent for “this Directive” substitute “the Regulations”;

(iv) in the second and third indents for “notified body” each time those words occur substitute “approved body”;

(d) in Section 4—

(i) for “notified body shall” substitute “approved body must”;

(ii) for both references to “Article 5” substitute “regulation 3A of the Regulations”;

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

(e) in Section 5—

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

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

(iii) for “an EC” substitute “a”;

(f) in Section 6—

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

(ii) omit “EC” each time it occurs;

(iii) for “the Directive” substitute “the Regulations”;

(g) for Section 7, substitute—

“7.   An approved body must cooperate with other approved bodies with regard to making available copies of the type-examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer.”.

29.   In Annex VI— E+W+S

(a) in the title omit “EC”;

(b) in Section 1—

(i) for “EC verification” substitute “Verification”;

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

(iii) for “EC type-examination” substitute “type-examination”;

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

(c) in Section 2.1—

(i) for “EC type-examination” in both places substitute “type-examination”;

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

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

(d) in Section 2.2 for “notified body” substitute “approved body”;

(e) in Section 4—

(i) for “notified body” in both places substitute “approved body”;

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

(f) in Section 5.1—

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

(ii) omit “EC”;

(iii) for “the Directive” substitute “the Regulations”;

(g) in Section 5.2 for “notified body” substitute “approved body”;

(h) in Section 6.2—

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

(ii) omit “EC”;

(iii) for “the Directive” substitute “the Regulations”;

(i) in Section 6.3 for “the harmonised standards referred to in Article 5” substitute “the designated standards referred to in regulation 3A of the Regulations”;

(j) in Section 6.4—

(i) for the first two paragraphs, substitute—

“Where the approved body has drawn up a written certificate of conformity in relation to a batch, all products in that batch to which that body has affixed, or caused to be affixed, an identification number may be placed on the market.”;

(ii) in the third paragraph, for “notified body”, in both places, substitute “approved body”.

30.   In Annex VII— E+W+S

(a) in the title and in Section 2, omit “EC”;

(b) in Section 2—

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

(ii) for “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”;

(c) in Section 3.1—

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

(ii) for “EC type-examination” substitute “type-examination”;

(d) in Section 3.2, for “EC type-examination” substitute “type-examination”;

(e) in Section 3.3 for the first two sentences substitute—

“The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2. The approved body must presume that quality systems which implement the relevant designated standards conform to the requirements.”;

(f) in Section 3.4—

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

(ii) for the first sentence of the second paragraph substitute “The proposed changes must be assessed by the approved body so as to verify whether the quality system after these changes would meet the requirements referred to in Section 3.2.”;

(g) in Sections 5.1 and 5.2, for each reference to “notified body” substitute “approved body”.

31.   In Annex VIII— E+W+S

(a) in Section 1—

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

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

(b) in Section 2, for “the Directive” substitute “the Regulations”;

(c) in Section 3—

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

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

32.   In Annex IX— E+W+S

(a) in the title, for “notified bodies” substitute “approved bodies”;

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

(c) in Section 1, for “authorised representative” substitute “UK responsible person”;

(d) in Section 2—

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

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

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

(e) in Section 3—

(i) for “has been notified” substitute “has been designated”;

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

(f) in Section 6, omit the words from “unless liability” to the end;

(g) in Section 7, omit the words from “(except vis à vis the competent administrative authorities” to the end.

33.   Omit Annex X.] E+W+S