Review of the MHRA International Recognition Policy

Entry
Comparable Regulatory Countries (CRC)
Proposed access routes
Basic requirements

Entry

On the 21st^street In May, the Medicines and Healthcare products Regulatory Agency (MHRA) published a statement on its policy intentions for the international recognition of medical devices. The aim is to describe the overarching policy for the recognition of other regulatory approvals for medical devices, including in vitro diagnostic medical devices. An update to the UK Medical Devices Regulations MDR 2002 will be expected in 2025-2026 in line with the principles described in this policy.

This is the first publication to set out the rationale and possible process for international recognition, and provides an overview of the process, with many details to be included when the draft statutory instrument is published later in the year.

Access routes cannot be used for the following types of devices/devices:

• Exempt internal devices
• Custom-made devices
• Some software as a medical device
• Companion diagnostics based on equivalence to a predicate or related drug substances that are not licensed in the UK

Comparable Regulatory Countries (CRC)

The principle of international recognition is the use of other regulatory regimes. This is typically based on the principles of the International Medical Device Regulatory Forum (IMDRF).

The initial CRCs described in the policy are:

• Australia
• Canada (Health Canada)
• European Union
• United States of America (FDA)

Proposed access routes

CRC recognition – Class A non-sterile

• Self-registration with the MHRA
• Declaration for the quality management system (ISO13485)

European Union Trust (IVDR) – Sterility class A, B, C, D

• Submission of technical documentation (IMDRF)
• Post-market surveillance plan and report (PMSR or PSUR)

Reliance on the Quick Assessment and Device Specific Requirements for Australia, Canada and the United States of America

• Submission of technical documentation (IMDRF)
• Post-market surveillance plan and report (PMSR or PSUR)
• Safety and Performance Summary (Class C and D)

Basic requirements

To gain access to the UK market, devices will need to meet certain UK requirements which may include:

• Packaging and labeling in English
• Have a UK Responsible Person (UKRP) (if the legal manufacturer is not based in the UK)
• They are assigned a UDI
• Meet UK post-market surveillance requirements

Further details on UK specific requirements are expected to be published in line with the IVD Roadmap. These will be specified in legal acts that will update the current Medical Devices Regulation.

Although the information provided is very extensive and much of the detail will be included in the draft SI documents, the approach taken by the MHRA should be seen as an extremely positive step. The proposed routes represent a pragmatic route, especially if using existing CE marking or 510(k) filings.

Time will tell what the roles and responsibilities of economic operators in the regulatory chain, including the UKRP, and the role of UK-approved bodies will be. However, we welcome the opportunity to read, understand and reflect on the possible process of international recognition.

The Abingdon Health team has over 20 years of experience in the lateral flow market and is a knowledge leader in the scale-up, transfer, manufacturing and regulatory approval of lateral flow products across multiple sectors including clinical (self-test, point-of-care), animal health , plant pathogens and environmental research.

If you would like to find out more about the regulatory process, including FDA, CE marking and UKCA marking, and to discuss any specific requirements, please contact us using the form below.