UK MHRA publishes consultation on indefinite recognition of CE marked medical devices

The UK MHRA has today published its promised public consultation on indefinite recognition of CE marked medical devices for the Great Britain (GB) (England, Scotland, and Wales) market (Northern Ireland already accepts CE marked devices).

The consultation invites views on the following proposals:

1. Extending the current transitional arrangements for devices that comply with the Medical Device Directive (MDD) to align with the EU timelines for devices to transition from MDD to EU Medical Devices Regulation
2. Indefinitely recognising devices that comply with the EU Medical Device Regulation (EU MDR) and EU in vitro Diagnostic Medical Devices Regulation (EU IVDR), and
3. Introduction of an international reliance route for devices classified higher in Great Britan than in the EU.

By way of background to the consultation, in July 2025, the MHRA published the government response to an earlier consultation on routes to market, which set out several proposals about the detail of a future international reliance scheme, which would enable swifter market access for certain devices that have already been approved in a comparable regulator country (including for CE marked medical devices).

A recurring theme in the consultation responses was the request to indefinitely extend the recognition of CE marked medical devices in accordance with current transitional arrangements, where ‘recognition’ in this context means acceptance of CE marked medical devices on the GB market without any domestic pre-market review. The Government committed to consulting on indefinite recognition of CE marked medical
devices in its response to the consultation, hence today’s publication.

Manufacturers (or their UK Responsible Person (UKRP)) would, however, continue to have to register their devices with the MHRA, meet the UK company and device registration requirements, and comply with the UK Post-market Surveillance (PMS) requirements.

The outcome of the consultation, which lasts until 10 April 2026, is almost certainly assured to agree with Proposal #2 for permanent CE mark recognition, which will be to the great relief of all device manufacturers wishing to market their devices in GB.