UK seeks views on indefinite CE marks for medical devices

The UK government has launched a consultation asking whether medical devices with CE marks issued in the EU and sold in Great Britain should be recognised indefinitely.

The Medicines and Healthcare products Regulatory Agency (MHRA) is hoping to address a critical regulatory issue for medical device manufacturers, namely that the current recognition of the CE mark is due to start expiring in 2028, following the UK's departure from the EU.

The MHRA's new proposal would remove these "sunset" dates and allow CE-marked medical devices to stay on the market indefinitely, without having to seek registration under the UKCA system set up after Brexit.

The regulator said that its aim is to ensure CE-marked medical devices remain accessible for patients, pointing out that 90% of all devices currently used in GB do so under the EU marking system.

The proposals also mean that the UKCA would be re-positioned as a specialist route for first-in-market innovative products, including AI as a medical device.

"The number one request that the medtech industry made of us was to provide long-term certainty over CE recognition," said MHRA chief executive Lawrence Tallon.

"It is in the best of interests of British patients to ensure continued access to the latest medical devices approved in Europe," he added. "It is also in the best interests of the med tech sector to reduce friction and costs of doing business."

The consultation is focusing on a number of areas, including extending the current transitional arrangements for devices certified under the EU's Medical Device Directive (MDD), to align GB timelines with the bloc's transition to the new Medical Device Regulation (EU MDR), which is being introduced in a phased fashion and is due to come fully into effect at the end of 2028.

Along with indefinite recognition of the CE mark, it would also introduce an international reliance route for a small proportion of such devices that would fall into a higher risk class under GB rules.

Commenting on the move, the Association of British HealthTech Industries (ABHI) said it welcomed the "practical step," adding that continued CE recognition "supports patient access, provides confidence for industry, and strengthens UK competitiveness."

It also pointed out that the consultation focuses only on extending recognition beyond the current 2028/2030 deadlines, with wider regulatory reforms to follow separately.

The consultation opens today (16th February) and will run until 10th April.