Explanatory note

These Regulations amend the Medical Devices Regulations 2002 (S.I 2002/618) (“the 2002 Regulations”) to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain. The 2002 Regulations were made under section 2(2) of the European Communities Act 1972, the Consumer Protection Act 1987 and the Finance Act 1973, and implemented Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC.

Regulation 4 substitutes regulation 1ZA of the 2002 Regulations. Regulation 1ZA makes provision for when regulations 19B, 19C, 30A, 44ZA and 44ZB will cease to have effect. The new regulation 1ZA sets out different dates ranging from 30 June 2023 to 30 June 2030. The effect of these new dates is that the period for placing devices on the market in Great Britain under regulations 19B and 30A (except custom-made devices), and 19C, 44ZA and 44ZB is extended.

Regulations 6 to 10 amend regulations 19B, 19C, 30A, 44ZA and 44ZB to make it clear that the manufacturer must ensure the certificate of conformity (if there is one) for the relevant device is valid before placing the device on the market. The amendments to regulations 19B, 30A and 44ZA provide that certificates issued under Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC that remain valid by virtue of the transitional provisions in Regulation (EU) 2017/745 or Regulation (EU) 2017/746, are considered valid for placing devices on the market in accordance with regulations 19B, 30A and 44ZA.

Regulations 6, 8, and 9 amend regulations 19B, 30A and 44ZA to provide that references to the relevant EU directive are references to that directive before it was repealed and the declaration of conformity must have been drawn up in accordance with those directives before they were repealed.

Regulations 6 and 9 insert new paragraphs in regulations 19B and 44ZA to exclude from their scope devices for which the conformity assessment under the relevant EU directive did not require the involvement of a notified body and for which the conformity assessment under the relevant EU regulation would also not require the involvement of a notified body (if it were assessed under that regulation). This reflects the transitional provisions in Regulation (EU) 2017/745 and Regulation (EU) 2017/746 that mean these devices can also no longer be placed on the EU market.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen. The explanatory memorandum is published alongside this instrument at www.legislation.gov.uk.