In the EU, lack of regulatory predictability is creating frustration, sending innovators across the Atlantic, and has been a factor in calls for a devices agency. MedTech Europe’s Oliver Bisazza and BVMed’s Marc Pierre Möll reviewed the top concerns aired at the MedTech Forum in early May.
Medtech companies will soon be able to reference an updated European version of the international risk management standard when proving compliance with the EU Medical Device Regulation.
New EU guidance aims to provide clarification, but some difficult and nuanced decision-making is still left to the manufacturer.
Only one new standard has been added to the official list of standards recognized in the context of the EU IVD Regulation in the latest update. The good news is that it is arguably one of the most needed standards by the IVD industry after the medtech quality management standard, ISO 13485.
With just a few weeks to go until the IVD Regulation fully applies, much-needed guidance has been published which discusses “significant changes” for legacy IVDs.
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