EU Has Now Designated 30 Notified Bodies For Medtech Products
Latest EU MDR notified body designation brings total in Italy to six, the same as Germany.
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In the EU, there are now six EU notified bodies designated under the IVD Regulation.
The regulation of clinical evidence and cybersecurity as well as lack of auditor availability were among the topics causing most concern to the medtech industry in September. But obstacles to the smooth implementation of the Medical Device and IVD Regulations persist and some actors are taking matters into their own hands.
EU member states need to decide some aspects of the EU’s medical device regulations, such as their competent authority and labeling language, for themselves. Here Italy explains its position.