MHRA opens consultation on future routes to market and IVDs under the UK medical device regulations

Key topics covered in the consultation are:

• International reliance: The MHRA remains committed to introducing an alternative market-access route for devices that have been approved in other “Comparable Regulator Countries” (CRCs), without needing a UKCA marking or certification. CRCs include the EU, USA, Canada and Australia, with a possible extension to Japan.

  The MHRA has proposed that the future international access route will be a ‘reliance’ and not a ‘recognition’ route, even for the EU. This means the MHRA will place significant weight on the assessments of CRCs but still reach its own decision. This would mark a significant shift for EU CE marked devices, which can under the current regime (which runs until 30 June 2028 or 30 June 2030 depending on the device) be placed on the market in Great Britian without further assessment.

  The proposed framework remains similar in structure to that proposed under the MHRA’s earlier Statement of policy intent: international recognition of medical devices, with four access routes proposed for different categories of devices and requirements for higher-risk devices (under routes 2, 3 and 4) to still undergo review by an Approved Body (organisations designated by the MHRA to assess medical devices).

  The international reliance route would not be available for all devices; notably software as a medical device with a US FDA 510(k) clearance would not be eligible for any of the routes.

• UKCA marking: Device that have undergone the UK conformity assessment process may no longer need to feature a physical UKCA mark in order to be placed on the Great Britian market. The MHRA is proposing removing this requirement; but would require that devices meet new UDI requirements, including bearing a UDI on the device and labels.
• IVDs: The MHRA has proposed replacing the current classification scheme with one better aligned with EU and international requirements. The new classification system will classify IVDs based on patient and public health risk (as opposed to disease-risk) into four classes: A, B, C, and D, with Class A being the lowest risk and Class D the highest risk. A key consequence of the new scheme will be that many IVDs will be moved into a higher risk class and will require Approved Body intervention in the conformity assessment process. The MHRA has, however, proposed a softer approach for ‘Class B’ IVDs than the EU-approach, with self-declaration and QMS certification to ISO13485 being required, as opposed to review by an Approved Body.

Responses to the consultation will inform the MHRA’s drafting of a statutory instrument to implement the proposed changes. The consultation closes on 5 January 2025 and the timing suggests the MHRA remains committed to its 2025 deadline for introducing a new framework for the future core regulations set out in its Roadmap towards the future regulatory framework for medical devices.

Authored by Jane Summerfield and Alexandra Wood.