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BIVDA welcome MHRA's statement of policy intent on international recognition

21 May, 2024 | Return|

The MHRA have today published a statement of policy intent for recognition by the UK of approvals of medical devices from international regulators.

They intend to recognise medical devices that have been approved in Australia, Canada, the EU and the USA.

BIVDA have been heavily involved in these proposals as a "trusted advisor" to the MHRA, and have worked closely with our UKCA working group and UK approved bodies to ensure member views are heard. A detailed policy submission was made to the MHRA, and will be made available to members via our usual channels.

BIVDA's Head of Regulatory Strategy, Professor Mike Messenger said "We welcome this new initiative from MHRA to adopt a 'smart' framework for reliance and recognition. This is in line with international best practice principles to increase regulatory efficiency and to ensure continued patient access to safe and effective IVDs.

"It is imperative this is complementary to a comprehensive and efficient UKCA framework with proportionate pre-market access requirements and robust post-market surveillance. BIVDA believe this is essential to incentivise inward investment through a 'UK-first' pathway. This will position UKCA as a global mark of quality and enhance the attractiveness of the UK as a destination for IVD development, manufacturing, evaluation and launch."

We have worked closely with stakeholders, members, and the MHRA to ensure this policy proposal balances the interests of our members, patients, and the diagnostic industry.

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