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I have now waded through all 66 pages of the European Data Protection Board’s draft guidelines on scientific research, and here’s a...
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The UK government published a renewed Women’s Health Strategy for England today, signalling a continued push to address long-standing...
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We’re pleased to share the 13th edition of our Biotech Review of the Year, bringing together practical legal, regulatory and commercial...
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This article is part of our Biotech Review of the Year - Issue 13 publication. Competition authorities are increasingly targeting...
The women’s health sector is undergoing significant transformation. A major driving force for this is the evolution of AI and the impact...
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At the time the Commission published its “Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices”, making...
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We wrote recently about the European Commission’s proposals to simplify the EU Medical Device Regulation (“MDR”)[1] and EU In Vitro...
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There is so much legislative change in the EU and UK in the life sciences sector at the moment that it is sometimes difficult to keep up...
Those working in the Femtech space have a difficult regulatory framework to navigate in the EU. For products that qualify as a medical...
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After years in the making, the much-awaited political agreement reached by the EU institutions on the so-called “EU pharma package” will...
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The European Commission has published its long-awaited proposal for a regulation to simplify the EU Medical Devices Regulation (“EU...
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The European Commission has recently published a draft implementing regulation under the EU Medical Devices Regulations (“EU MDR”)[1] and...