MHRA Consultation on CE Marked Medical Device Recognition

Detected February 16th, 2026

Summary

The MHRA has launched a consultation on proposals for the indefinite recognition of CE-marked medical devices in Great Britain. The consultation seeks views on extending transitional arrangements for MDD-compliant devices and indefinitely recognising EU MDR/IVDR compliant devices, with a comment deadline of April 10.

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What changed

The Medicines and Healthcare products Regulatory Agency (MHRA) is consulting on significant changes to how CE-marked medical devices will be recognised in Great Britain. Key proposals include extending transitional arrangements for legacy devices (MDD) to align with EU timelines, indefinitely recognising devices compliant with the EU Medical Device Regulation (EU MDR) and EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR), and introducing an international reliance route for higher-classified devices. This consultation is open to all impacted parties, including manufacturers, distributors, healthcare professionals, and patient organisations.

Regulated entities, particularly medical device manufacturers and distributors operating in Great Britain, should review these proposals and consider submitting feedback by the deadline of April 10. The outcome of this consultation will shape the future regulatory landscape for CE-marked devices, potentially impacting market access, compliance strategies, and transition timelines. Failure to engage with the consultation could result in a lack of representation for specific industry concerns in the final regulatory framework.

Source document (simplified)

Open consultation

Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices

From: Medicines and Healthcare products Regulatory Agency Published 16 February 2026 Get emails about this page

Consultation description

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on proposals for the approach to recognising CE marked medical devices in Great Britain.

We welcome the views from anyone who will be impacted by the proposals, including medical device manufacturers and distributors, trade associations, regulatory experts, approved bodies, healthcare professionals including clinicians and those involved in procurement of medical devices, devolved administrations and patient representative organisations.

We are inviting views on the following proposals:

Extending the current transitional arrangements for devices that comply with the Medical Device Directive (MDD) to align with the EU timelines for devices to transition from MDD to EU Medical Devices Regulation
Indefinitely recognising devices that comply with the EU Medical Device Regulation (EU MDR) and EU in vitro Diagnostic Medical Devices Regulation (EU IVDR), and
Introduction of an international reliance route for devices classified higher in Great Britan than in the EU. This consultation applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.

Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices

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