The Good And Bad News When It Comes To EU Notified Bodies’ Designation Capacity

The entire medtech sector is all too aware of the lack of capacity among notified bodies to support the EU medical device and IVD regulations. But what really matters is how much notified body capacity there is in a given product area as this will have the most influence on conformity assessment timelines for individual products.

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Searching For A Notified Body With Capacity In Your Area Can Be Challenging • Source: Shutterstock: kurhan

Only two of the 31 notified bodies designated under the EU Medical Device Regulation (MDR) are authorized to carry out conformity assessments under all MDR product codes.

Meanwhile, four out of the seven designated under the IVD Regulation have full authorization under the IVDR.

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