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The regulatory world is nervously awaiting the full effects of the EU’s new requirements for medical and in vitro diagnostic device manufacturers that distribute products in EU markets. The retrofitted regulations place a greater emphasis on safety evidence that can be backed by clinical data and are, therefore, expected to have a considerable impact on the clinical research of any medical devices that are intended for EU markets. The coinciding unease triggered by the UK’s plausible ‘no-deal’ Brexit is intensifying anxieties about the regulatory changes and potential ripple effects. The looming deadlines and uncertainties provide ample reason for device organisations to make certain they understand the impending changes and ensure their clinical research data are ready for the revamped EU regulatory landscape.

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About the author


Patricia Santos-Serrao started her career in the life science industry in 1994 at Schering-Plough in Kenilworth, New Jersey, US, and later joined Boehringer Ingelheim Pharmaceuticals in Ridgefield, California. She took a leading role within both organisations in transitioning business processes, document management, and submission compilation from a paper to electronic system. Patricia is a member of RAPS and has earned her regulatory affairs certification from RAPS and the Regulatory Affairs Certification Board. She is a member of the DIA and the DIA-sponsored TMF Reference Model Working Group.
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