EU MDR and EU IVDR (In Vitro Diagnostic)

The new European Medical Device Regulation (MDR) and the EU Regulation on In Vitro Diagnostics (IVDR) will replace the existing Medical Device Directives. The timetable for the publication has shifted further. Meanwhile one goes from summer 2017 out. Manufacturers are […]

Notified bodies in the EU are not obliged to make unannounced checks on medical device manufacturers

Judgment of the European Court of Justice of 16 February 2017: Notified bodies in the EU are not obliged to make unannounced checks on medical device manufacturers. In the case of liability claims for harmful medical devices, reference must be […]

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