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Fabien Roy

Partner - Hogan Lovells

1 blog from the author

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Regulation

Posted on 13.05.2019

Notified Bodies are becoming a regulatory bottleneck

The new EU regulations on medical devices and in vitro diagnostics (IVDs) share a laudable aim: They seek to modernise the regulatory framework and enhance transparency. The goal, shared by all stakeholders, is to enhance patient safety without harming innovations that improve patient outcomes. However, with these two regulations coming into force by May 2020 […]

By Fabien Roy Partner - Hogan Lovells