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Update on Notified Bodies designation under MDR / IVDR

The implementation of the new European MDR (2017/745), now in place since May 2021 and IVDR (2017/746) less than a year away, has proven to be a very challenging task...
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EUDAMED is LIVE

The Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746 include use, maintenance and management of a European databank on medical devices (EUDAMED). The database consists of...
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Europe’s pragmatic approach to clinical evidence for legacy devices – or why the devil is always in the detail…

Regulatory affairs demand attention to detail. So when the European Medical Devices Coordination Group released document MDCG 2019-3 - Interpretation of Article 54(2)b we regulatory geeks just knew we should...
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Halfway there? Will the MDR/IVDR train arrive on time – and what about Brexit?

As the implementation journey for the EU MDR/IVDR passes the halfway point, we provide an update to the current state of play and the impact on our industry. Many, if...

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