First Belgian Notified Body Appointment Brings EU MDR Total To 25
Every new notified body designation under the Medical Device Regulation is being welcomed by medtech companies as the countdown continues for the grace period to end in May 2024.
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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.
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.
The regulation of products on the drug/device borderline has always been complex. New EU guidance aims to provide clarification, but some difficult and nuanced decision-making is still left to the manufacturer.