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MHRA explores new framework for international medical device recognition

The Medicines and Healthcare products Regulatory Agency (MHRA) has made a statement of policy intent which could signal an important move toward a new regulatory framework for medical devices in the UK.

The MHRA sets out how it intends to recognise regulatory approvals from Australia’s Therapeutic Goods Administration, the United States’ Food and Drug Administration, Health Canada, and relevant national bodies residing in member states of the European Union and European Economic Area.

Discussions are ongoing with Japan’s Pharmaceuticals and Medical Devices Agency as to whether it could join that list.

The government highlights that, while the proposed framework is still in draft, the final move will:

  • Protect public health
  • Ensure access to MedTech innovations
  • Maintain an attractive market for industry

“We will continue to work on how our intended policy on international recognition of medical devices will operate in practice,” said the MHRA’s chief quality and access officer, Dr Laura Squire.

“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.”

The MHRA maintains the authority to reject applications if the evidence provided is deemed inadequate. It also highlights that manufacturers will still have the option to use the UK Conformity Assessed (UKCA) marking process in order to access the British market.

Laura continued: “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.”

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Image credit: iStock

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