Commission Predicts 43 Notified Bodies Under MDR And 12 Under IVDR By End November
Altered compliance timelines under the EU’s Medical Device and IVD Regulations give the sectors more time. But urgency remains for manufacturers to hire notified bodies to assess their products. Expanded capacity bandwidth is promised soon.
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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.
With a population of just over 5.5 million, Finland represents just 1.2% of the EU’s total population. Its testing capacity under the EU's IVD Regulation, in terms of numbers of notified bodies, now appears proportionately bigger than that of any other country.