BIVDA has welcomed a statement of policy intent published by MHRA for recognition by the UK of approvals of medical devices from international regulators.
BIVDA has been heavily involved in these proposals as a ‘trusted advisor’ to the MHRA, and has worked closely with its UKCA working group and UK approved bodies to ensure member views are heard.
BIVDA's Head of Regulatory Strategy, Professor Mike Messenger (pictured above) 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 believes 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."
BIVDA has worked closely with stakeholders, members, and the MHRA to ensure this policy proposal balances the interests of our members, patients, and the diagnostic industry.