Medical Devices Citation, extent and application 1 1 These Regulations may be cited as the Medical Devices (Amendment) (Great Britain) Regulations 2023. 2 These Regulations extend to England and Wales, Scotland, and Northern Ireland. 3 These Regulations apply in relation to Great Britain. Commencement 2 1 Regulations 1 to 4 come into force on 30th June 2023. 2 Regulations 5 to 10 come into force on 1st July 2023. Amendments to the Medical Devices Regulations 2002 3 The Medical Devices Regulations 2002 are amended in accordance with regulations 4 to 10. Amendments to regulation 1ZA (expiry of certain provisions in these Regulations) 4 For regulation 1ZA , substitute— 1ZA 1 Subject to paragraph (3), regulations 19B and 30A cease to have effect at 23:59 on 30 June 2028. 2 Subject to paragraph (3), regulations 19C, 44ZA and 44ZB cease to have effect at 23:59 on 30 June 2030. 3 The following cease to have effect at 23:59 on 30 June 2023— a regulation 19B(4), (5), (8) and (9); b regulation 19C(8) and (9); c regulation 30A(4) to (7); d regulation 44ZA(4) and (5); e regulation 44ZB(4) and (5). . Amendments to regulation 2 (interpretation) 5 In regulation 2(1) after the definition of “Regulation (EU) No 722/2012” insert— “ Regulation (EU) 2017/745 ” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC , Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ; “ Regulation (EU) 2017/746 ” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU ; . Amendments to regulation 19B (obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42) 6 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). . Amendments to regulation 19C (obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745) 7 1 Regulation 19C is amended as follows. 2 After paragraph (3)(b) insert— ba ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn; . 3 For paragraph (7) substitute— 7 This paragraph applies where, before a system or procedure pack is placed on the market, the person responsible for combining devices to produce that system or procedure pack— a has complied with the relevant requirements of Article 22 including where that Article requires a conformity assessment in accordance with Annex IX or XI; and b ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn. . Amendments to regulation 30A (obligations in Part III which are met by complying with obligations in Directive 90/385) 8 1 Regulation 30A is amended as follows. 2 In paragraph (1)(a)— a after “Directive 90/385” insert “as it had effect on 25 May 2021” ; b omit “as amended from time to time”. 3 In paragraph (3)— a after sub-paragraph (b) insert— ba ensures that the 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; ; b in sub-paragraph (f) for “draws up” substitute “has drawn up before 26 May 2021” . Amendments to regulation 44ZA (obligations in Part IV which are met by complying with obligations in Directive 98/79) 9 1 Regulation 44ZA is amended as follows. 2 In paragraph (1)(a) for “amended from time to time” substitute “it had effect on 25 May 2022” . 3 In paragraph (3)— a at the beginning insert “Subject to 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 110(2) of Regulation (EU) 2017/746; ; c in sub-paragraph (f) for “draws up” substitute “has drawn up before 26 May 2022” . 4 After paragraph (3) insert— 3A Paragraph (3) only applies to a relevant device for which the conformity assessment procedure under Article 9 did not require the involvement of a notified body, if the conformity assessment procedure for that device under Article 48 of Regulation (EU) 2017/746 would require the involvement of a notified body. . Amendments to regulation 44ZB (obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746) 10 In regulation 44ZB , after paragraph (3)(b) insert— ba ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn; . Will Quince Minister of State, Department of Health and Social Care 9th June 2023