Great Britain to Indefinitely Recognise CE-Marked Medical Devices and IVDs

Date

October 21, 2026

Category

UK Regulations

Description

The UK Government has confirmed its intention to indefinitely recognise CE-marked medical devices certified under Regulation (EU) 2017/745 on medical devices (EU MDR) and in vitro diagnostic medical devices certified under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (EU IVDR) in Great Britain.

Eligible devices will therefore continue to access the markets of England, Scotland and Wales without an additional UK conformity assessment. The UKCA route will remain available as a domestic route to market.

For eligible legacy devices certified under Council Directive 93/42/EEC concerning medical devices (MDD), the Government intends to align Great Britain’s recognition timelines with the applicable EU MDR transitional arrangements.

Manufacturers must continue to comply with applicable national requirements, including MHRA registration, appointment of a UK Responsible Person where required, and UK post-market surveillance obligations.

The necessary legislative amendments are expected to be introduced before 30 June 2028 and remain subject to parliamentary approval. Until they enter into force, the current Great Britain transitional arrangements continue to apply.

Further information: assets.publishing.service.gov.uk/media/6ad76f8be9713babfbe3f755/Government_response_to_the_targeted_consultation_on_indefinite_recognition_of_CE_marked_medical_devices.pdf