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.
When does an app qualify as a medical device and when does it not? A German court case appears to have wider-reaching implications for medtech than might first appear.
The EU Batteries Regulation is yet another legal instrument medical device manufacturers must address over the coming years alongside the core Medical Device and IVD Regulations.