UK MHRA Announces Draft Recognition Policy Access Routes

By Karen Hill and Evangeline Loh

This is the second post in our series on the UK MHRA initial draft recognition policy. Following our initial post, this regulatory update describes the access routes in the UK MHRA’s draft policy to leverage international regulatory authorizations.

As we at Emergo by UL have shared, the MHRA posted (May 21) their draft policy to consider regulatory authorizations from certain international regulators, and comparable regulator countries (CRCs). (Four former founding Global Harmonization Task Force (GHTF) members comprise the CRC: Australia TGA, Health Canada, the EU and the U.S. FDA).

Based on the UK classification (generally EU classification), one of four access routes would be available: recognition (self-registration), reliance, reliance with device-specific requirements and reliance with abridged assessment and device-specific requirements.

UK MHRA Draft Policy access routes: Recognition (self-registration)

Devices that are Class I self-certified or IVDs that are Class A nonsterile in the UK and possess CRC authorization would be self-registered. In addition, the MHRA has indicated that compliance with the Quality Management System (QMS) standard ISO 13485 or a “product-specific equivalent” is expected.

UK MHRA Draft Policy access routes: Reliance

The reliance route is available to medical devices that are compliant with the EU Medical Devices Regulation (2017/745, MDR) or In Vitro Diagnostics Devices Regulation (2017/746, IVDR). This includes medical devices and IVD classifications with an MDR and IVDR Notified Body-issued CE marking certificate, except when there is a difference in classification between the EU and UK or for Artificial Intelligence as a Medical Device (AlaMD).

A copy of the complete technical documentation file in the International Medical Device Regulators Forum (IMDRF) table of contents format or similar would be submitted with the post-market submission  (PMS) plan and PMS Report or Periodic Safety Update Report (PSUR).

UK MHRA Draft Policy access routes: Reliance with device-specific requirements

This route is available for medical devices when the leveraged regulator is TGA or U.S. FDA (premarket approval (PMA)). Similar to the Reliance route the complete technical documentation file would be provided, as well as the PMS Plan, PMS Report or PSUR. Also, evidence of approval will be reviewed.

In addition, implantable devices would require implant cards and patient information leaflets and implantable and Class III devices would require a summary of safety and clinical performance.  

UK MHRA Draft Policy access routes: Reliance with abridged assessment and device-specific requirements

In this route, the MHRA delineated all the probable examples.

Similar to the reliance and the reliance with device-specific Requirements routes, the complete technical documentation file would be provided, as well as the PMS Plan, PMS Report or PSUR. The device classification would be reviewed.

Similar to the reliance with device-specific requirements route, implantable devices would require implant cards and patient information leaflets, and implantable and Class III devices would require a summary of safety and clinical performance. In addition, Class C and D IVDs also require a summary of safety and clinical performance. The MHRA exerts the prerogative to sample clinical data.

For AIaMD there will be a review of premarket (training and test) data, implementation verification and validation and use of predetermined change control plans.

Timing and next steps

This is a proposed policy document. The MHRA expects this to be implemented with the future UK medical device legislation, planned “to be in force in 2025.”

The operational details are still in discussion, in a process described by the MHRA as “under trusted advisor principles in stakeholder discussions including industry, designated approved bodies and applicant approved bodies going through the designation process”. This proposed regulator leveraging system will be tested by MHRA.

Concluding remarks

There are a lot of details in the four draft access routes. The UK remains highly aligned with the EU. For higher-risk devices (in which the classification is identical between the EU and UK), when the manufacturer has an MDR or IVDR Notified Body CE marking certificate, the access route that is the easiest is reliance. The other routes potentially require more review. And, MHRA has indicated the system is being tested and the operational details are still under development.

This represents the UK MHRA’s commitment to global harmonization and reliance. Global harmonization persists, though it will come in various forms.