New Amendments to UK Medical Device Regulations: What You Need to Know

In a significant update for the medical device industry, the UK government has announced amendments to the Medical Devices Regulations 2002. These changes, encapsulated in the Medical Devices (Amendment) (Great Britain) Regulations 2025, were made official on May 14, 2025, and will come into force on May 24, 2025.

Key Changes:

1. Revocation Dates Removed: The amendments specifically remove the planned revocation dates for several pieces of EU legislation that had been assimilated into UK law. These regulations were initially set to expire on May 25th and 26th, 2025. The affected regulations include:

   • Commission Decision 2002/364, which sets technical specifications for in vitro medical devices.
   • Commission Regulation (EU) No 207/2012, concerning electronic instructions for medical devices.
   • Regulation (EU) No 722/2012, which addresses requirements for active implantable medical devices and those using tissues of animal origin.
   • Regulation (EU) No 920/2013, focused on the designation and oversight of notified bodies for medical devices.

2. Scope and Application: The amendments extend to England, Wales, Scotland, and Northern Ireland but apply only to England, Wales, and Scotland.

3. Objective and Consultation: The primary goal of these changes is to safeguard public health. The Secretary of State conducted a public consultation and determined that the benefits of retaining these regulations outweigh any risks, particularly concerning the safety of medical devices.

4. No Significant Impact: According to the explanatory note, the government does not anticipate a significant impact on the private, voluntary, or public sectors, thus no full impact assessment has been produced.

These amendments are part of the UK's ongoing efforts to regulate medical devices effectively while maintaining high safety standards. For those in the medical device industry, it is crucial to stay informed about these changes to ensure compliance and continue prioritizing patient safety. For further details, the explanatory memorandum is available on the UK legislation website.