Government response to consultation on Medical Devices Regulations: EU law assimilated

On 26 February 2025, the MHRA (Medicines and Healthcare products Regulatory Agency) published its response to the public consultation on the Medical Devices Regulations: Routes to Market and In Vitro Diagnostic Devices. This response addresses the issue of maintaining assimilated EU regulations, which were due to expire on 26 May 2025.

After reviewing comments from industry and other stakeholders, the British government decided to maintain four key EU regulations to avoid regulatory gaps and ensure patient safety. These regulations include:

✔ Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (IVDs);
✔ Regulation (EU) 207/2012 on electronic instructions for use of medical devices;
✔ Regulation (EU) 722/2012 on requirements for medical devices manufactured from tissues of animal origin;
✔ Regulation (EU) 920/2013 on the designation and supervision of approved bodies.

In addition, the MHRA plans to update the reference to Regulation (EU) 207/2012 in UK legislation, replacing it with the latest Implementing Regulation (EU) 2021/2226, as part of future reforms to medical device regulation in the UK.

This decision provides greater predictability for manufacturers and companies operating in the UK market. However, further changes are expected as the MHRA develops its Pre-Market legislation, which could impact requirements for high-risk IVDs and remove temporary approvals for COVID-19 tests.

For more details, please refer to the full PDF document below.