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 doing well to deal with the new regulations and to use the time. In particular, non-EU manufacturers with a medical device should address new requirements. Non-EU manufacturers who do not have a branch in the EU must do so by means of a proxy. This…Continue Reading “EU MDR and EU IVDR (In Vitro Diagnostic)”

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 made to national law.

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