MHRA confirms international reliance routes, IVD changes, UDI approach and plan for indefinite CE recognition for medical devices

The Government has confirmed it will implement international reliance frameworks for medical devices and has announced proposals for indefinite recognition of CE-marked devices.

The response to a consultation on medical device reforms, UKCA marking and IVD requirements sets out details of the expected reforms and the changes from the original proposals.

Key changes include: 

• Reversal of the previous exclusion of software as a medical device (SaMD) approved under the 510(k) route in the US, which will now be eligible for the international reliance route 
• route 2 of the international reliance framework will not be implemented
• there will be a consultation on indefinite recognition of CE-marked devices

The response was published in July 2025. You can read about the original consultation in our previous post. 

A summary of the response is below.

International Reliance

The response confirms that three of the proposed routes in the proposed framework will be implemented, in relation to devices approved in Australia, Canada, the EU and the USA. 

Devices would need to be registered with the MHRA and meet GB-specific requirements. These requirements include having English language labelling and packaging, a UK Responsible Person, a unique device identifier (UDI), and complying with post-market surveillance (PMS) requirements.

Routes 1, 3 and 4 of the framework will be introduced. Significantly, SaMD and implantable Class IIb and III devices approved under the 510(k) route in the USA will now be eligible for route 4, provided they “demonstrate entire equivalence”. The requirements for equivalence will be set out in new regulations and are summarised in Annex C of the consultation response.

UKCA Marking

The requirement for UKCA marking for devices, and their associated labelling, will be removed, provided that manufacturers assign a Unique Device Identification (UDI) to the device and the UDI is searchable in a public database.

This change will be implemented after the database is operational and the transitional period for the introduction of UDI has concluded. 

Responding to re-labelling concerns, it was confirmed that there would be no requirement to remove the UKCA marking from devices, and their associated labelling, where this is already present.

In Vitro Diagnostic Devices

The consultation proposed that IVD devices would be classified into four risk classes, which will align with the IMDRF principles, giving closer alignment to the EU regime, with some notable differences.

The consultation proposed that a UKCA self-declaration of conformity and QMS certification to ISO 13485 are suitable pre-market controls to ensure that a Class B IVD device is safe for patient use (as opposed to requiring a CE conformity assessment by a notified body in the EU).

The response confirms these measures will be implemented. Manufacturers will have 5 years to adapt to the updated regulations, also noting the proposals to consult on indefinite recognition of CE marked devices above.

Looking ahead

Manufacturers will need to examine how they can take advantage of international reliance routes, CE recognition proposals, UDI requirements and IVD changes to update their regulatory and market access strategies in the UK.

If you would like to discuss any of the above, please contact a member of our Healthcare Team. 

This article was written by Rory Trust and Olivia Twynham-Richardson