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EU and UK Life Sciences: MDR/IVDR Transition, CMA TTBER Review, Thermo Fisher/Olink, EMA Oligonucleotide/Vaccine Guidance, UK Naloxone/Windsor SIs, ASA Rulings — 1 August 2024

Published on: 01 August 2024

Published by a LexisNexis Life Sciences expert
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Medical devices

EU Competent Authorities publish statement on medical devices regulatory framework status

The European Commission is undertaking a targeted review of the medical devices regulatory regime set out in Regulation (EU) 2017/745 (the Medical Devices Regulation, MDR) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation, IVDR), collectively the ‘Regulations’. Following a workshop in France, national EU Competent Authorities have released a joint statement on the current state of the transition to these measures. Since their adoption seven years ago in 2017, stakeholders have faced a range of challenges and invested considerable effort in delivering implementation. There have been marked delays in progress and in the practical application of the new framework; costs have risen for all sides, with limited transparency or predictability. Alongside planning difficulties and capacity constraints at various points in the system, this has fostered uncertainty and hesitancy in moving across to the Regulations...

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