September 19, 2021
The UK Medicines & Healthcare Products Regulatory Agency (MHRA) has published a new public consultation on a proposed post-Brexit regulatory framework for medical devices scheduled to take effect in 2023.
The new consultation solicits feedback from stakeholders on planned changes to the UK’s Medical Devices Regulations 2002 as part of a broader transition away from European Union legal and regulatory systems; beginning in July 2023, the MHRA will no longer accept EU CE Marking for medical devices, and will instead require manufacturers to obtain UK Conformity Assessment (UKCA) marking in order to legally sell their devices in England, Scotland, Wales and (with special considerations) Northern Ireland.
How closely will UK regulations align with EU MDR?
Upon first reading, the planned UK regulatory changes do not deviate significantly from the European Medical Devices Regulation (MDR) now in effect across the EU. (Emergo by UL consultants will provide more in-depth analysis of these changes in the near future.)
Key elements of the proposed UK medical device regulatory changes for 2023 include:
- New UK market access pathways to support faster patient access to novel and innovative devices;
- A “unique, innovative, and ambitious framework” for oversight of software as a medical device (SaMD) and artificial intelligence (AI) as it relates to medical devices;
- Amended in vitro diagnostic (IVD) regulations, including updated device classification schemes and patient risk review processes;
- Enhanced sustainability processes for re-use and re-manufacturing of medical devices in order to reduce reliance on single-use devices in the UK.
The MHRA notes that changes to the UK medical device regulatory framework will likely entail greater reliance on guidance documents in conjunction with regulations in order to support both device innovation and patient safety.
The agency is soliciting public comment on medical device regulatory changes through November 25, 2021.