MHRA proposes indefinite acceptance of CE-marked medical devices

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is requesting feedback on a proposal to allow EU CE-marked medical devices sold in Great Britain to be recognized and sold indefinitely. This measure aims to ensure a continuous and uninterrupted supply of these devices. The announcement was made as part of a targeted consultation on Monday.

The UK's recognition of the CE mark will expire on 30 June due to its exit from the EU market.

The agency noted that “most manufacturers have delayed transitioning to UKCA (UK Conformity Assessed) while the international reliance scheme was developed. As a result, approximately 90% of medical devices on the GB market remain CE marked today.”

The consultation applies to general medical devices, active implantable medical devices (AIMDs) and in vitro diagnostic (IVD) devices marketed in Great Britain, which includes England, Scotland, and Wales.

The agency is requesting feedback on whether this proposal should apply to all devices or only to those classified as the same risk level or lower according to the UK’s Medical Device Regulations 2002, in comparison to the relevant EU device regulations.

The agency stated that “devices that are recognised under this proposal would continue to be placed on the GB market without additional checks by an approved body. This would reduce the risk of interruption to the supply of medical devices for patients in GB.”

To ensure that the MHRA has proportionate oversight of all medical devices in the Great Britain market, regardless of how they are brought to market, the agency is considering changes related to market surveillance, compliance and enforcement.

MHRA further noted that accepting this proposal would mean there would be no ongoing approved body oversight of these devices once they are placed on the Great Britain market, including certain post-market surveillance requirements. Instead, the devices would have undergone a review by an EU notified body before being placed on the market and would continue to be monitored by an EU notified body in accordance with EU regulations.

Another proposal would extend current transitional arrangements for devices certified under the EU’s Medical Device Directive (MDD), aligning Great Britain’s timelines with the EU’s transition to the EU Medical Device Regulation (EU MDR).

MHRA stated that devices approved under the MDD, which are in the process of transitioning to the EU MDR, can be sold in the Great Britain market until 31 December 2028. This is an extension from the previous deadline of June 30. The proposal aims to align this timeline with the EU's, allowing medical devices with a valid CE certificate to continue being placed on the Great Britian market, provided they comply with the transitional arrangements of the MDR 2002.

The third proposal would introduce an international reliance route for devices that comply with the EU Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation where the risk classification is higher than under the UK MDR. The agency said that “for the small proportion of devices that would be classified higher under the classification rules in MDR 2002 than in the EU MDR or EU IVDR, this proposal will introduce an international reliance route.”

The consultation includes three questions on each proposal.

The announcement was prompted by the government’s response to a public consultation on routes to market published in July 2025. (RELATED: MHRA to move forward with medical device reliance plans, Regulatory Focus 22 July 2025)

MHRA said that “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 Great Britain 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.”

According to Lawrence Tallon, chief executive at MHRA, “The number one request that the med tech industry made of us was to provide long term certainty over CE recognition. It is in the best of interests of British patients to ensure continued access to the latest medical devices approved in Europe. It is also in the best interests of the med tech sector to reduce friction and costs of doing business. We have listened carefully and acted on this clear and consistent feedback, which is why we are now pleased to consult on these proposals for indefinite recognition of CE marked medical devices.

Consultation notice

MHRA proposes indefinite acceptance of CE-marked medical devices

Related topics

Recommended content

Welcome to the new RAPS Digital Experience