UK Medical Device Regulators Remove Revocation Dates for Assimilated EU Laws

By Karen Hill

As previously reported, during a public consultation launched in November 2024, the UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), proposed removing the revocation dates of four pieces of assimilated EU law so that they remain part of the statutory framework for medical devices in Great Britain (GB) until they are replaced with the updated UK law.

Publication of Statutory Instrument No. 591

Medical devices and IVDs on the GB market are regulated under the Medical Devices Regulations 2002 (UK MDR 2002), which combined three EU Directives into national law. As such, the UK MDR 2002 refers to several other pieces of assimilated EU law, which form part of the regulatory framework for GB. Statutory Instrument No 591 was published on May 23, 2025, to amend UK MDR 2002 and came into effect on May 24, 2025.

It removes the revocation dates of May 26, 2025, for four following assimilated EU laws:

• Commission Decision 2002/364 on the common specifications for in vitro diagnostic medical devices
• Commission Regulation (EU) No 207/2012 on electronic instructions for the use of medical devices
• Regulation (EU) No 722/2012 concerning particular requirements for medical devices manufactured utilizing tissues of animal origin
• Regulation (EU) No 920/2013 on the designation and the supervision of approved bodies

Concluding remarks

Removing these revocation dates provides continuity in the regulation of medical devices in the UK by maintaining the regulatory status quo and prevents causing a significant gap in the regulatory framework. It also reduces the risk to patient safety. These assimilated laws are not intended to be kept in place indefinitely but serve as a temporary measure until more permanent measures are in place, with the publication of the new UK medical device framework.

It may also be of interest that the Post-Marketing Surveillance Statutory Instrument Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, SI 2024 No. 1368,  comes into force June 16. And, there has been guidance published related to the PMS SI.