The UK Medicines and Healthcare products Regulatory Agency (MHRA's) has published a Statement of policy intent: international recognition of medical devices outlining its proposal for the International Recognition Procedure (IRP) of medical devices in Great Britain.
The statement follows the “MHRA's” 2022 commitment to introduce alternative routes to market for medical devices in Great Britain based on approvals from other countries and Medical Device Single Audit Program (MDSAP) certificates, in addition to the current UK Conformity Assessment (UKCA) marking process. This development is part of the MHRA's shift to a “‘smarter’ form of regulatory oversight, resulting in more predictable, faster approvals to improve access to quality-assured medical devices for patients”.
The MHRA statement intends the IRP will be available to manufacturers whose devices have already been approved by regulators in the following comparable regulator countries (CRCs): Australia, Canada, the European Union and the USA and meet certain eligibility criteria including English language labelling and packaging, Great Britain electronics compatibility requirements, and UK Medical Devices Regulation (MDR) post-market surveillance requirements.
The IRP will be distinct from the current UKCA mark and lead to a certificate of international recognition. Devices that are authorised under the IRP process can be placed on the Great Britain market for as long as the certificate from the CRC remains valid.
Different assessment requirements will apply depending on the type and class of the medical device, and whether the device classification is different in the CRC to that under the UK MDR. The MHRA proposes to exclude certain types of medical device from the IRP, including software as a medical device (SaMD) and artificial intelligence as a medical device (AIaMD) that do not satisfy the “MHRA's” intended purpose guidelines (published in early 2023) or have been approved via a route which relies on equivalence to a predicate.
Next Steps
The statement is the “MHRA's” current proposal for the international recognition of medical devices and there are further aspects of the IRP still to be confirmed. For example, the MHRA statement does not provide an indication of how long the IRP certificate application process will take. The final IRP framework is expected to be released in 2025 at the same time as the upcoming changes to the UK Medical Devices Regulations 2002 (UK MDR).
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