UK MHRA consults on Indefinite Recognition of CE Marked Medical Devices

The consultation sets out three main proposals:

• To extend the current transitional arrangements for devices that comply with the EU Medical Device Directive (MDD) to align with the EU timelines for transition to the EU Medical Device Regulation (MDR). This would mean that devices approved under the MDD could be placed on the Great Britain market until 31 December 2028, rather than 30 June 2028.
• To indefinitely recognise devices that comply with the EU MDR and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). Manufacturers would continue to register their devices with the MHRA but would not need to undergo additional assessment by a UK Approved Body. The MHRA is seeking views on whether this should apply to all devices or only those which are classified as the same or a lower risk category under the UK Medical Device Regulations 2002 (UK MDR), reflecting that for some devices risk classification currently differs between the UK MDR and the EU MDR/IVDR.
• To introduce an international reliance route for devices that comply with the EU MDR and IVDR where the device classification is higher under the UK Medical Devices Regulations 2002 (MDR 2002) than in the EU, if the outcome of the second proposal is to limit recognition to only those devices classified as the same or a lower risk category under the UK MDR. This would allow such devices to access the GB market through a streamlined review process, rather than the full UKCA conformity assessment.

If implemented, these proposals would provide manufacturers with ongoing flexibility to use either the CE or UKCA route to market in Great Britain (i.e. England, Scotland and Wales; EU MDD/MDR and IVDD/MDR continue to apply directly in Northern Ireland), reducing the regulatory burden and costs for manufacturers marketing devices across both the EU and UK that already hold CE certification.

The MHRA would also need to consider further changes to ensure sufficient regulatory oversight of CE marked devices on the Great Britain market, for example access to surveillance audits and technical files.

Manufacturers are encouraged to consider the impact of the proposals on their product portfolio and current regulatory strategy, and to contribute their views to the consultation.

The consultation is open until 10 April 2026 and responses will inform the development of a statutory instrument to implement the proposed changes into law as an amendment to the Medical Devices Regulations 2002.

Authored by Jane Summerfield, Bonella Ramsay, Alexandra Wood, and Bea Watts.