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IMQ Appointment As Fourth Notified Body Under MDR: Good News But Big Questions

 
• By Amanda Maxwell

There are now four notified bodies designated under the new EU Medical Device Regulation. But that is not enough, and new designations do not mean immediate testing either.

Questions

While there has been much excitement this morning on social media about Italian testing and certification body, IMQ, becoming the fourth notified body to be officially designated against the EU Medical Device Regulation (MDR), the news also raises serious questions about how the European Commission will manage to officially designate some 20 by the end of the year, as it has promised.

As predicted, the official designation of IMQ in the Nando database on 20 August followed that of DEKRA six days earlier. There are now four notified bodies under...

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