CE marking UK: Indefinite recognition planned, UK Responsible Person still required

Great Britain intends to recognize CE marked medical devices and in vitro diagnostic devices (IVDs) under the EU Medical Devices Regulation (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) indefinitely. The UK government announced this on 21 October 2026, and the current end date of 30 June 2030 is set to go.

The new rules are not yet in force, and the obligations on the Great Britain market stay the same: manufacturers without a place of business in the UK still need a UK Responsible Person. Registration with the MHRA (Medicines and Healthcare products Regulatory Agency) and the strengthened post-market surveillance requirements also remain.

In brief

•     CE marking under the EU MDR and EU IVDR is to be recognized in Great Britain indefinitely. The current end date is 30 June 2030.

•     The change still requires legislation, subject to parliamentary approval.

•     UKCA remains a separate route to market in Great Britain.

•     The UK Responsible Person, MHRA registration, PMS obligations and English-language documentation remain mandatory.

What the UK government has decided on CE marking

The UK government's decision of 21 October 2026 follows a targeted consultation by the MHRA, which ran from 16 February to 10 April 2026 and received 1,056 responses. 57 % of respondents supported indefinite recognition for all devices.

The government will indefinitely recognise "all CE marked medical devices certified under EU MDR and EU IVDR". It rejected one alternative: a separate recognition route for devices that are classified higher in Great Britain than in the EU. Its reason was that this would add unnecessary regulatory complexity.

The change is not yet in force. The government will implement it through legislation, which still needs parliamentary approval; until then, the current rules apply.

The decision applies to Great Britain (England, Scotland and Wales); Northern Ireland still applies certain EU rules and has separate guidance.

UKCA vs CE: Two routes to the Great Britain market

Even with indefinite recognition of CE marking after Brexit, the UKCA (UK Conformity Assessed) mark remains Great Britain's own route to market. According to the MHRA, a pre-market statutory instrument will update the requirements for UKCA marked devices. The announcement gives no timeline for it.

Indefinite CE recognition removes the pressure for manufacturers with CE marking under the MDR or IVDR to switch to UKCA by 2030. Manufacturers that already hold UKCA certification can keep using that route.

What remains mandatory for manufacturers

Indefinite CE recognition covers only conformity marking. All other requirements of the UK Medical Devices Regulations 2002 remain in place. The government response of 21 October 2026 names these explicitly:

•     Manufacturers without a place of business in the UK must appoint a UK Responsible Person (UKRP).

•     Devices must still be registered with the MHRA. Manufacturers established in the UK register their devices themselves; manufacturers without a place of business in the UK do so through their UKRP.

•     The strengthened post-market surveillance (PMS) requirements in force since June 2025 continue to apply, including faster reporting of serious incidents.

•     Technical documentation and the certificate of conformity must be available in English.

•     Manufacturers must comply with MHRA enforcement notices under the Medicines and Medical Devices Act 2021.

The EU Authorized Representative (EU-REP) does not cover Great Britain. The EU-REP and the UKRP are separate roles, each established in its own territory.

→ Learn more about the UK Responsible Person

Once the legislation is in place, manufacturers with MDR or IVDR certification can keep using CE marking in Great Britain. Until then, the current rules apply, and the UK Responsible Person and MHRA registration are required either way.

GOV.UK press release, 21 October 2026

Government response to the targeted consultation on indefinite recognition of CE marked medical devices, 21 October 2026

Reviewed by the MedNet EC-REP Regulatory Affairs team · Last updated: 30.10.2026