MHRA Launches Targeted Consultation on Indefinite Recognition of CE‑Marked Devices

The consultation, published on 16 February 2026 and updated on 19 March 2026, invites views from stakeholders across the healthcare and medical device sectors. The consultation closes at 11:59pm on 10 April 2026.

Purpose of the Consultation

The MHRA is seeking feedback on proposed regulatory changes that would shape how CE‑marked devices continue to be accepted in the GB market. This move aims to maintain supply continuity, support innovation, and align aspects of the UK framework with international regulatory developments.

Key Proposals

The consultation asks for views on three main areas:

• Extending existing transitional arrangements for devices certified under the older Medical Device Directive (MDD), aligning the UK’s timelines with those set by the EU.
• Indefinite recognition of devices compliant with the EU Medical Device Regulation (EU MDR) and EU In Vitro Diagnostic Regulation (EU IVDR).
• Introducing a new international reliance route, allowing certain devices—particularly those categorised as higher‑risk in Great Britain than in the EU—to rely on international regulatory assessments.

Who the MHRA Wants to Hear From

MHRA is encouraging responses from all groups affected by medical device regulation, including:

• Manufacturers and distributors
• Approved bodies and regulatory experts
• Clinicians, healthcare professionals and procurement teams
• Trade associations and patient representative organisations
• Devolved administrations

How to Respond

Stakeholders can respond online, via email to: futuredevicesregulations@mhra.gov.uk, or by post to the MHRA’s Canary Wharf office.

Click below to read the full post and to respond to the consultation:

Source: Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices – GOV.UK

Respond here: Proposal 1 – Medical devices regulations: consultation on the indefinite recognition of CE marked devices