The MHRA has launched a consultation on proposed changes to the regulatory requirements a medical device must meet before it is placed on the market in Great Britain. The consultation will close on 5th January 2025.
The consultation will focus on four policy areas that have evolved significantly since the MHRA’s initial consultation to strengthen medical devices legislation was launched in 2021. These four areas are part of broader regulatory reforms that respond to recommendations set out in the Independent Medicines and Medical Devices Safety (IMMDS) review.
The four policy areas that the MHRA is consulting on are:
- UKCA marking – The MHRA is seeking views on whether to remove the requirement for physical UKCA marking in light of introducing UDI requirements.
- International reliance – The MHRA is seeking views on a detailed policy framework for International Reliance, building on the policy statement shared earlier this year.
- In vitro diagnostic (IVD) devices – The MHRA is seeking views on the regulatory requirements for Class B IVD devices to gain market access.
- Assimilated EU law – The MHRA is seeking views on a proposal to remove the revocation date of four pieces of assimilated law so that they remain part of the statutory framework for medical devices in Great Britain until the transition to an updated medical devices regime. The four pieces of law are:
- Commission Decision 2002/364 on the common specifications for in vitro diagnostic medical devices
- Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
- Regulation (EU) No 722/2012 concerning particular requirements for medical devices manufactured utilising tissues of animal origin
- Regulation (EU) No 920/2013 on the designation and the supervision of approved bodies.
The Association will be submitting a full response to the consultation. Members are encouraged to submit individual company responses, and to share any feedback to [email protected] by 11th December 2024 to inform the BDIA’s submission.
