International Recognition of Medical Devices

Introduction
Comparable Regulator Countries (CRCs)
Proposed Access Routes
Basic Requirements

Introduction

On the 21^st May, the Medicine & Healthcare products Regulatory Agency (MHRA) published a Statement of policy intent for the international recognition of medical devices. The purpose is to describe the overarching policy for recognising other regulatory approvals for medical devices including IVDs. The update to the UK Medical Device Regulations MDR 2002 will be expected in 2025-2026 following the principles described in this policy.

This is the first publication that lays out a rationale and possible process for international recognition, and is a top-level view of the process, where much of the detail will be covered when the Draft Statutory Instrument is published later in the year.

The access routes may not be used for the following device/device types:

• Exempted in-house devices
• Custom-made devices
• Some Software as a Medical Device
• Companion Diagnostics relying on equivalence to a predicate, or where associated medicinal substances that are not licenced in the UK

Comparable Regulator Countries (CRC’s)

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

The initial CRCs described in the policy are:

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

Proposed Access Routes

Recognition of CRCs – Class A non-sterile

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

Reliance of European Union (IVDR) – Class A sterile, B, C, D

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

Reliance with Abridged Assessment and Device Specific Requirements of Australia, Canada and United States of America

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

Basic Requirements

To access the UK market, the devices will be required to meet specific UK requirements, these could include:

• English packaging and Labelling
• Have a UK Responsible Person (UKRP) (if the legal manufacturer is not based in the UK)
• Have a UDI assigned
• Comply with UK post-market surveillance requirements

Further details on the UK specific requirements are expected to be published in alignment to the IVD roadmap. These will be laid down within the Statutory Instruments which will update the current Medical Device regulation.

While the information provided is very broad, and much of the detail will be provided in the draft SI documents, the approach taken by the MHRA should be seen as a hugely positive step. The routes proposed provide a pragmatic route, especially if utilising existing CE marking, or 510(k) submissions.

It remains to be seen what the roles and responsibilities for the economic operators in the regulatory chain are, including the UKRP, and the role of UK Approved Bodies. However, we welcome the opportunity to read, understand and reflect on the possible process for International Recognition.

Abingdon Health’s team has over 20 years’ 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 aa range of sectors including clinical (self-test, point of care), animal health, plant pathogen and environmental testing.

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