The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently launched a public consultation on proposals for continued recognition of CE-marked medical devices in Great Britain (the Consultation).
Following Brexit, the MHRA introduced the UKCA mark for medical devices in Great Britain (i.e., England, Scotland, and Wales) to replace the CE mark used in the EU. However, the UK government has repeatedly extended transitional measures allowing CE-marked devices to be placed on the Great Britain market — until 30 June 2028 or 30 June 2030, depending on the device and applicable EU law — in order to facilitate the continued supply of medical devices to the market.
The Consultation seeks feedback on three MHRA proposals:
The MHRA has proposed to allow CE-marked devices under the EU Medical Devices Regulation 2017/745 (EU MDR) or the EU In Vitro Diagnostic Medical Device Regulation 2017/746 (EU IVDR) to be placed on the Great Britain market indefinitely. Under this proposal, CE-marked devices would not require additional checks by an approved body but would still need to be registered with the MHRA.
The MHRA is particularly interested in seeking views on whether the proposal should apply to all EU MDR- and EU IVDR-compliant devices or only those devices classified in the same or a lower risk class under the UK Medical Devices Regulations 2002 (UK MDR).
If indefinite recognition of CE-marked devices only applies to devices classified under EU MDR or EU IVDR in the same or a lower risk class under the UK MDR, then the MHRA has proposed an international reliance route for other CE-marked devices.
Under this proposal, CE-marked devices which are in a higher risk class under the UK MDR than under the EU MDR or EU IVDR would not be automatically recognised in Great Britain. Instead, they would benefit from “international reliance” (i.e., a streamlined approval pathway), but a UK-approved body would still conduct its own review of the devices — taking into account EU MDR or EU IVDR assessments — to determine whether to grant an international reliance certificate. The manufacturer could then rely on this to register the CE-marked device with the MHRA and place it on the Great Britain market.
The MHRA has proposed to extend the current transitional period from 30 June 2028 to 31 December 2028, during which certain CE-marked devices in compliance with the EU Medical Devices Directive 93/42/EEC (EU MDD) can be placed on the Great Britain market. Currently, certain medical devices in compliance with the EU MDD can be placed on the EU market until 31 December 2028, subject to certain conditions, after which they must comply with the EU MDR. This proposal would therefore allow these devices to continue to be placed on the Great Britain market for the same period as they may be placed on the EU market.
The Consultation complements wider planned reforms to the UK medical device regulatory framework expected later this year. It is open until 10 April 2026, and responses may be submitted here.
Latham & Watkins will continue to monitor developments in this space and provide further updates as the regulatory landscape evolves.