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MHRA publishes proposed MedTech regulatory framework



The Medicines and Healthcare products Regulatory Agency (MHRA) has published a proposed framework for international recognition of medical devices to ensure access to MedTech innovations.

The MHRA’s statement of policy intent describes how the UK Government intends to recognise regulatory approvals from Australia, Canada, the European Union and the United States of America, depending on device type, class, and prior approval.

This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensures access to MedTech innovations, and maintains an attractive market for industry

The focus is on ensuring safe access to quality-assured medical devices and reducing the duplication of assessments by comparable regulators, so resources can be spent on more innovative products which could benefit patients.

This statement will also allow manufacturers to start considering whether their devices will be eligible for the proposed alternative routes to market.

The proposed framework is still in draft form with the final version expected to be an integral part of future core regulations.

Dr Laura Squire, chief quality and access officer of the MHRA said: “Today’s 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.

“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.”

The MHRA continues to review the list of comparable regulator countries and is in active discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) to explore the recognition of medical device approvals from Japan.

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