MetaMedical™ Solutions Inc

MHRA proposes international medical device recognition framework

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a proposed framework for the global recognition of medical devices.

In a statement of policy intent, the agency detailed the UK Government’s intent to acknowledge regulatory approvals from specific countries.

This policy aims to facilitate access to quality-assured medical devices and streamline the assessment process.

It focuses on certain device types and classes, with prior approvals from Australia, Canada, the EU, and the US being considered for recognition.

This initiative is designed to reduce the duplication of assessments by comparable regulators, allowing resources to be allocated to evaluate more innovative products.

In addition to the countries already listed, the MHRA is in talks with the Pharmaceuticals and Medical Devices Agency (PMDA) to include Japan among recognised regulatory bodies.

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The statement also serves as a preliminary guide for manufacturers, enabling them to assess the eligibility of their devices for alternative routes to market under the proposed framework.

However, the framework is currently in draft form, with the final version to be integral to the core regulations that govern medical devices in the UK.

MHRA chief quality and access officer Dr Laura Squire said: “The announcement is an important step forward towards a robust medtech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need and ensures the UK remains an attractive market for medical technology innovators.

“We will continue to work on how our intended policy on international recognition of medical devices will operate in practice. By sharing the draft policy now, we aim to give greater clarity about the MHRA’s future direction of making regulatory approvals simpler, where it is safe to do so. At the same time, we remain fully committed to the UKCA marking for medical devices.”

The latest development comes after the MHRA unveiled its AI Airlock sandbox model for assessing virtual and real-world projects through simulation and helping develop AI as a medical device.

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