Notified Body Pain Points: The Challenges And Obstacles Industry Needs To Avoid

Article posted on 20 November 2020 on Medtech Insight
Author: Amanda Maxwell | Source of Original Article

Executive Summary

Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?


Medtech companies need to do an in-depth check that their notified bodies will be able to still service them under the new EU Medical Device Regulation, Bassil Akra advised delegates at the Medtech Summit in October organized by Informa Connect. Akra is CEO and co-owner of Qunique consultancy.

Do not expect, because you have been working with a notified body for many years, that it will get the same designation scope under the MDR as under the Medical Devices Directive (MDD), warned.

Akra was chairing a session entitled Notified Body Panel Discussion: EU MDR Pain Points, the most popular session at the virtual meeting. Topics covered included potential auditing bottlenecks, capacity and staffing, what notified bodies see as the biggest challenge for manufacturers in submitting their applications for conformity assessment and alignment in notified body operations.

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