CE

Implant

Custom Devices, Clinical Trials and the Hazards of Precedent

This past week an interesting post cropped up in the RAPS discussion board. An Australian member asked about doing clinical trials of custom-made medical devices. A surgeon inventor wanted to...
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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...
Brexit

Brexit – BSi confirms UK issued CE to become invalid

Brexit - this is where the wheels come off: UK (and now Dutch) Notified Body BSi has advised that all UK issued CE certificates become invalid in case of no...

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