The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has recently announced the introduction of a 12-month extension to the implementation of the future Medical Device Regulations, which were subject to public comment last year (see our update here). The aim is to bring the new regulations into force by July 2024. CE marked devices will continue to be accepted on the Great Britain (GB) market for a further 12-month period beyond 30 June 2023, as currently stated in the Medical Device Regulations 2002 (UK MDR 2002).
The UK Government intends to introduce legislation by Spring 2023 bringing in force transitional arrangements and post-market surveillance requirements. Manufacturers of medical devices will be able to continue to place CE marked devices on the GB market after 1 July 2023; and from July 2024, the transitional arrangements will apply to CE and UKCA marked devices placed on the GB market. These transitional arrangements will then be reflected within the UK MDR 2002 once it is amended.
In accordance with the World Trade Organisation rules, the Secretary of State will share the draft regulations for comment for at least 60 days prior to them being laid in Parliament. This will provide key stakeholders an opportunity to review and comment on the draft legislation before it comes into force. Note that the current guidance on medical devices is still in the process of being updated to reflect the extended timelines for implementing the future Medical Device Regulations.
Should you have any questions regarding this or any other life sciences or healthcare regulatory matter in the UK or abroad, please do not hesitate to reach out to us.