MHRA announces plan to recognise medical devices approved by other major regulatory bodies
The Medicines and Healthcare products Regulatory Agency (MHRA) has outlined its intended policy [1] for recognizing medical device approvals from major regulatory bodies like those in Australia, Canada, the European Union, and the United States.
In a statement published on May 21, 2024, the agency described plans to accept approvals from these comparable regulators for certain device types and classes that have already undergone rigorous review elsewhere.
This policy aims to reduce duplicative assessments and free up resources to focus on evaluating novel, innovative devices that could benefit patient health. The MHRA states it is still actively reviewing which countries beyond the EU, US, Canada and Australia may be added, with ongoing discussions about including approvals from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Dr Laura Squire, MHRA’s Chief Quality and Access Officer, commented: “This 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.”
MHRA’s future direction
She added: “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.”
While outlining this draft framework for accepting some approvals from overseas counterparts, the MHRA affirmed its dedication to the UKCA mark and expanding domestic review capacity for medical devices.
“We continue to expand capacity in UK Approved Bodies and to work to ensure UKCA marking supports safe and earlier access to the most innovative and transformative medical products,” Dr Squire said.
The details provided indicate the MHRA’s intent to streamline certain medical device approvals by leveraging prior reviews from trusted regulators worldwide. However, the agency underscored that its paramount goals remain ensuring patient safety and access to cutting-edge technologies through a robust regulatory system in the UK.
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