UK MHRA Announces Draft Recognition Policy for Access to Global Medical Device Markets

By Karen Hill and Evangeline Loh

This is the first in our series on the UK MHRA initial draft recognition policy to leverage international regulatory authorizations for access to the medical device market.

The UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) hosted a webinar in March on the update of the draft medical devices scope, classification and essential requirements. This was a follow-up to the roadmap for the 2024-2025 year. Then, there was no information about leveraging regulatory authorizations from other countries/jurisdictions, despite June 30, 2030 being communicated as the last date to leverage compliance with the EU CE marking.

A draft international recognition policy for medical devices was announced (May 21).

Background on UK MHRA Draft Policy

The MHRA acknowledges the importance of global harmonization and leveraging regulatory authorizations. This is aligned with the World Health Organization (WHO) and conclusions from the International Medical Device Regulators Forum (IMDRF) 25^th annual meeting. The MHRA champions that this “represents a ‘smarter’ form of regulatory oversight, resulting in more predictable, faster approvals to improve access to quality-assured medical devices for patients.”

UK MHRA Draft Policy: Comparable regulator countries

The proposed regulatory authority authorizations to be leveraged are referred to as comparable regulator countries (CRCs). The CRCs are comprised of the former founding Global Harmonization Task Force (GHTF) members, Australia TGA, Health Canada, the EU and the U.S. FDA. While the Japan MHLW was not included in the initial draft, it is being considered as a CRC.

In addition to CRC compliance, the MHRA delineated regulatory requirements specific to Great Britain: labeling in English, compliance with electronics legislation and units of measure, designation of a UKRP, Unique Device Identifier and post-market surveillance (PMS).

The classification of the devices (and corresponding access routes) is proposed to be based on UK Medical Devices Regulation. The proposed UK legislation is closely aligned with the European regulations. This also means that differences in classification may exist between the product in the selected CRC and the UK.  

Use of this international recognition route would permit a manufacturer to market in Great Britain, though would not yield the UKCA marking certificate (or UKCA marking).

UK MHRA Draft Policy: Specific Cases

The MHRA also discusses details related to specific cases. When the CRC authorization is indefinite, such as the one provided by the U.S. FDA, the international recognition would be based on the Quality Management System, like the one cited by the Medical Device Single Audit Program (MDSAP) certificate.

There is also a list of devices excluded from this international recognition route.

UK MHRA Draft Policy: Access Routes

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.

Our next Regulatory Update will provide details of these different access routes.

Concluding remarks

Our next feature will elaborate on the different access routes as well as share information about the proposed next steps and timing.

This is an exciting development and represents the commitment of the UK MHRA towards global harmonization. To provide some commentary, the Brazil regulator, ANVISA, identified their Equivalent Foreign Regulatory Authority (AREE) as the four former GHTF members, less the EU. And, there have been recent developments related to MDSAP, including the U.S. FDA rule to align the Quality Management System Regulations (21 CFR 820) to ISO 13485.

Global harmonization is here to stay though it will come in various forms.

All in all, this is welcome news.