MHRA公布CE认证医疗器械无限期认可咨询结果

Read the full outcome

Detail of outcome

This document sets out the government response to the targeted consultation on the indefinite recognition of CE marked medical devices in Great Britain (England, Wales, and Scotland). The consultation ran from 16 February 2026 to 10 April 2026 and received 1056 responses from a wide range of stakeholders, including medical device and in vitro diagnostic (IVD) device manufacturers, UK responsible persons, approved bodies, notified bodies, healthcare professionals, patient groups and individuals.

We invited views on three proposals:

• Extending the current transitional arrangements for devices that comply with the EU Medical Devices Directive 93/42 (EU MDD) to align with the EU timelines for devices to transition from EU MDD to the EU Medical Devices Regulation 2017/745 (EU MDR)
• Indefinitely recognising devices that comply with the EU MDR 2017/745 and EU in vitro Diagnostic Medical Devices Regulation 2017/746 (EU IVDR), and
• Introduction of an international reliance route for devices classified higher in Great Britain than in the EU.

A majority of respondents supported extending transitional timelines for EU MDD-compliant devices to align with EU deadlines, noting that this would prevent supply disruption and reduce unnecessary administrative burden.

A majority of respondents also supported the indefinite recognition of all CE marked devices certified under EU MDR and EU IVDR. Respondents noted that this approach would streamline access to innovative technologies, reduce duplicative regulatory processes and support growth in the UK MedTech sector. However, some stakeholders raised concerns regarding regulatory oversight, accountability and the UK’s ability to independently assure safety and performance.

Most respondents did not support the introduction of a separate reliance route for devices classed higher in GB, noting that this would introduce a level of regulatory complexity that was disproportionate to any potential safety benefits.

Having considered the responses, the government intends to proceed with legislative changes to indefinitely recognise CE marked medical devices certified under EU MDR and EU IVDR, while aligning Great Britain transitional arrangements for EU MDD-compliant devices with EU timelines. This approach is intended to maintain continuity of supply, support ongoing patient access to safe and effective devices and reduce administrative burdens on manufacturers.

Manufacturers of CE marked devices placed on the Great Britain market will continue to be required to comply with certain domestic requirements, including appointment of a UK responsible person, MHRA registration, and post-market surveillance (PMS) obligations. The MHRA remains responsible for monitoring the safety of all medical devices in the UK, regardless of their route to market.

These changes form part of the wider programme to reform the UK medical devices regulatory framework, ensuring it remains proportionate, internationally aligned and supportive of both patient safety and innovation.

The proposed approach applies to the regulatory framework for Great Britain. For guidance on the regulation of devices in Northern Ireland, please refer to published guidance on the Regulation of devices in Northern Ireland. The indefinite recognition of the CE mark in Great Britain further supports the internal market and supply to Northern Ireland by ensuring that manufacturers can place the same product on the UK-wide market.

Original consultation

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.

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