UK confirms indefinite recognition of CE-marked medical devices in Great Britain

📅 MHRA announcement: 21 October 2026

🇬🇧 On 21 October 2026 the MHRA (Medicines and Healthcare products Regulatory Agency) announced the UK Government’s decision to recognise CE-marked medical devices and in vitro diagnostic devices (IVDs) indefinitely in Great Britain (England, Scotland and Wales).

The decision follows the public consultation held between February and April 2026 and confirms the Government’s intention to keep accepting CE-marked devices on the Great Britain market, with no end date.

✨ What the announcement confirms

The UKCA marking route remains available as the domestic conformity assessment pathway, but is no longer required to access the market.
The MHRA will continue to oversee device safety through strengthened post-market surveillance (PMS) requirements.
Continued recognition of CE-marked devices is intended to avoid duplication of regulatory approval routes for manufacturers.
Further regulatory reforms are being developed, including measures for emerging technologies such as software and AI medical devices.
Manufacturers can continue to place devices on the GB market using their current UKCA certificates.
To place devices on the market with a UKCA mark, a valid UKCA certificate is required; to do so with a CE mark, valid EU certification is required (including MDR/IVDR).

🏥 What it means for manufacturers

For a manufacturer holding CE marking under the MDR or IVDR, the British market stays accessible without additional certification: keep the EU certification valid and meet the UK requirements for MHRA registration, a UK Responsible Person (UKRP) for manufacturers based outside the UK, and post-market surveillance. Those who already invested in UKCA can keep using it. And it is worth following the announced reforms on PMS, software and AI closely, as they will introduce new obligations.

Source: official announcement by the UK Government and the MHRA.

At MeDev Consulting we support medical device and IVD manufacturers with CE marking under the MDR/IVDR and with access to other markets, including the United Kingdom. Contact us at: info@medev.es