# The Medical Devices (Amendment) (Great Britain) Regulations 2023, Regulation 6: Amendments to regulation 19B (obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42)


(1) Regulation 19B is amended as follows.
(2) In paragraph (1)(a)—
(a) after “Directive 93/42” insert “as it had effect on 25 May 2021”;
(b) omit “as amended from time to time”.
(3) In paragraph (3)—
(a) at the beginning insert “Subject to paragraph (3A),”;
(b) after sub-paragraph (b) insert—
“(ba) ensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;”;
(c) in sub-paragraph (f) for “draws up” substitute “has drawn up before 26 May 2021”.
(4) After paragraph (3) insert—
“(3A) Paragraph (3) only applies to a class I device under the Directive if—
(a) the conformity assessment procedure under Article 11 required the involvement of a notified body; or
(b) the conformity assessment procedure for that device under Article 52 of Regulation (EU) 2017/745 would require the involvement of a notified body (if it were to be assessed under that regulation).”.
(5) In paragraph (7)—
(a) after sub-paragraph (b) insert—
“(ba) ensures that any certificate in relation to the system or procedure pack or a device within it that was issued by a notified body under the Directive is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;
(bb) ensures that the declarations required by Article 12 were drawn up before 26 May 2021;”;
(b) at the end of sub-paragraph (c) omit “and”;
(c) at the end of sub-paragraph (d) for “English.” substitute “English; and”;
(d) after sub-paragraph (d) insert—
“(e) ensures that the system or procedure pack does not contain a class I device under the Directive for which—
(i) the conformity assessment procedure under Article 11 did not require the involvement of a notified body; and
(ii) the conformity assessment procedure under Article 52 of Regulation (EU) 2017/745 would not require the involvement of a notifed body (if it were to be assessed under that regulation).”.

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Source: https://www.legislation.gov.uk/ukdsi/2023/9780348247657/regulation/6 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-amendment-great-britain-regulations-2023/regulation-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.