Many people ask me these days: why the urgency with IVDs? The IVDR’s date of application (26 May 2022) is still almost two years away. Why the hurry?
The hurry has everything to do with simply counting back from the date of application and understanding the requirements of the IVDR.
Notified bodies are very scarce
By now, everybody will know that 85% of the IVDs under the IVDR need conformity assessment by a notified body as a result of a radically new classification mechanism – also the devices [...]
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