The UK Government, through the Medicines and Healthcare products Regulatory Agency (MHRA), has announced plans to amend the Medical Devices Regulations 2002 for Great Britain by adopting the EU Common Specifications for high-risk in vitro diagnostic (IVD) devices. This move aims to enhance patient safety while reducing regulatory burden for manufacturers.
What’s Changing?
Under the proposed update:
- The Common Specifications developed at the EU level will be adopted for high-risk IVD devices, including tests for infectious diseases (e.g. Hepatitis B/C/D, HIV, Syphilis), blood grouping, and tissue typing.
- The Coronavirus Test Device Approvals (CTDA) process will be repealed, with an interim accelerated pathway introduced for CE-marked COVID-19 IVDs that meet the EU IVDR and Common Specification requirements.
Why This Matters
By aligning with European standards, the MHRA aims to:
- Ensure IVDs meet high standards of performance backed by robust clinical evidence
- Streamline market access for manufacturers across the UK and EU
- Reduce duplicated effort and support regulatory harmonization
These changes are expected to be formalized later this year, as part of the UK’s broader medical device regulatory reform program.
Official Source: Government to align with European specifications on high-risk in vitro diagnostic devices to reduce regulatory burden
Published by MHRA on 10 July 2025
