Exciting Update: Istituto Superiore di Sanità Now Accredited for IVDR!

A new key player has been designated for the In Vitro Diagnostic Regulation (IVDR)! The Istituto Superiore di Sanità (NB 0373), based in Italy, has been recently accredited as a notified body. With this addition, the total number of notified bodies under the IVDR now stands at 13.

What does this mean for in vitro diagnostic device manufacturers?
This new designation gives manufacturers more flexibility in choosing their notified body for IVDR certification, helping streamline the compliance process and ease market access.

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