Turkey Notches Up Two Notified Bodies Under EU’s Medical Device Regulation In Two Weeks
There are now 41 notified bodies in total under the EU’s Medical Device Regulation.
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In the EU, notified bodies are usually designated for a wide spectrum of testing of different types of medical devices under the Medical Device Regulation. The latest organization to be named, however, is a specialist.
Turkey may not be part of the EU, but its customs agreement with the bloc enables it to designate notified bodies under the EU’s Medical Device and IVD Regulations. The first such designation has just been announced.
There are 10 listings in the first group of EU reference laboratory to be named. They will not formally assess IVDs for about a year and even then only evaluate products that are in a later batch to comply with the IVD Regulation.