UK confirms indefinite acceptance of CE marked medical devices after 1,000-response consultation

The UK government said on 21 October 2026 that Great Britain will keep accepting CE marked medical devices and in vitro diagnostic devices (IVDs) on a long-term basis, ending uncertainty over whether EU-approved products would eventually need a separate UK approval ¹. The MHRA announced the decision after a public consultation that ran from 16 February to 10 April 2026 and drew more than 1,000 responses from patients, healthcare organisations, industry and others ¹.

What the government decided

Manufacturers whose devices already hold EU approval will not have to go through an additional UK route to sell in Great Britain ¹. The scale is large: more than 90% of medical devices registered for use in Great Britain currently carry a CE mark ¹. The products named by the MHRA run from insulin pumps and replacement joints to diagnostic tests and surgical equipment ¹.

The domestic UKCA mark stays in place as the approval pathway for devices placed on the GB market ¹. Its requirements are being updated through a pre-market statutory instrument ¹. Separately, the government will keep pursuing powers in primary legislation for a future licensing approach to devices, which it says should cope better with software and AI medical devices, in line with recommendations from the National Commission into the Regulation of AI in Healthcare ¹. Oversight continues through post-market surveillance and reporting requirements that are already in force and through the Yellow Card scheme, with safety information shared with international partners ¹.

MHRA chief executive Lawrence Tallon said the decision “gives patients, the NHS and industry the long-term certainty they need on access to medical devices” ¹. He added that the agency's wider reforms would prepare the framework for new technologies “including AI-powered medical devices” ¹.

What it means for the market

For device makers, including health-tech and diagnostics companies, the main effect is that a single EU conformity assessment continues to open the GB market, so firms avoid the cost and delay of duplicate certification ¹. Steve Lee, executive director of regulation at the ABHI, said “Regulatory predictability and avoiding unnecessary duplication are fundamental to industry investment decisions” and called long-term recognition of CE marking “a significant and welcome decision” ¹. He also pointed to continuity of supply for “digital health technologies” alongside devices and IVDs ¹.

For NHS buyers, the government frames the move as protecting stable supply and patient access to the technologies trusts rely on ¹. The MHRA links it to its 2030 Strategy, which aims to widen reliance and recognition routes with trusted regulators, and to the Life Sciences Sector Plan and the 10 Year Health Plan ¹.

The decision settles the near-term route to market but leaves the longer-term shape of UK device regulation open. The licensing model for software and AI devices still depends on primary legislation that has not yet been secured, and the announcement gives no timetable for it or for the UKCA statutory instrument ¹.

Caveats

The announcement is the government's own account of the consultation outcome, and the full response is published separately on GOV.UK ¹. It does not say how the arrangement would change if EU and UK device rules diverge further. The next step the government names is a programme of engagement sessions with patient groups to explain the response and answer questions on safety and oversight as the arrangements are put in place ¹.