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Medical Devices / Regulatory Affairs

Notified Bodies Warn of Future Bottlenecks in Implementing New Device Regs

Jan. 8, 2019

The European Association for Medical Devices of Notified Bodies (Team-NB) is sounding alarms over the shortage of notified bodies to conduct audits and certify devicemakers in time to comply with the new European medical device regulations.

The association released the results of a survey of its members that gauged readiness to implement the EU’s new device and IVD regulations by the deadline of May 2020.

Team-NB questions whether it is possible that all manufacturers and all products will be certified according to the new MDR before May 2020. The answer:  “Most likely not — because the “new” notified bodies will not be able to assess and take certification decisions for all applications before May 2020!”

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