Statutory Instruments
Medical Devices
Made
at 2.32 p.m. on 24th May 2021
The Secretary of State, in exercise of the powers conferred by sections 50(3) and 51(1) of the Medicines and Medical Devices Act 2021(1), makes the following Regulations.
1.—(1) These Regulations may be cited as the Medicines and Medical Devices Act 2021 (Commencement No. 1 and Transitional and Savings Provision) Regulations 2021.
(2) In these Regulations, “the Act” means the Medicines and Medical Devices Act 2021.
(3) These Regulations extend to England and Wales, Scotland and Northern Ireland.
2. The 26th May 2021 is the day appointed for the following provisions of the Act to come into force—
(a)Chapter 3 of Part 4 (enforcement) except for section 31 (civil sanctions),
(b)sections 39 and 40 (disclosure of information and offences),
(c)section 41(1) to (8) (consequential and supplementary provision).
3.—(1) For the purposes of section 12 of the Consumer Protection Act 1987(2), the Medical Devices Regulations 2002(3) continue to be recognised as safety regulations as if subsections (1), (3), (4), (6) and (8) of section 41 of the Act had not been commenced in accordance with regulation 2(c).
(2) Paragraph (1) ceases to have effect on the commencement of section 41(9) of the Act.
Bethell
Parliamentary Under-Secretary of State,
Department of Health and Social Care
At 2.32 p.m. on 24th May 2021
(This note is not part of the Regulations)
These Regulations commence certain provisions of the Medicines and Medical Devices Act 2021 (‘the Act’) on 26th May 2021. Regulation 2 brings the whole of Chapter 3 of Part 4 of the Act (enforcement), apart from section 31 (civil sanctions), into force, along with sections 39 and 40 (disclosure of information) and subsections (1) to (8) of section 41. Regulation 3 preserves the application of the offence in section 12 of the Consumer Protection Act 1987 to medical devices until such time as subsection (9) of section 41 is brought into force along with Schedule 3 to the Act. Part 1 of Schedule 3 inserts a new offence into the Medical Devices Regulations 2002, which will replace the section 12 offence.
S.I. 2002/618. These Regulations have been amended on a number of occasions, most recently by S.I. 2019/791 (as amended by S.I. 2019/1385 and S.I. 2020/1478) for the purposes of the Regulations as they apply in Great Britain and by S.I. 2020/1478 for the purposes of the Regulations as they apply in Northern Ireland.