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Designation Of EU Notified Bodies: Is There Evidence Of Bias?

 
• By Amanda Maxwell

With the EU having now announced 20 notified body designations against the EU’s Medical Device and IVD Regulations, some clear patterns have emerged. But the Commission denies any bias.

CRM

A total of 14 of the 16 organizations that have been designated so far against the EU’s Medical Device Regulation are ̶ or have recently been ̶ members of the European association of notified bodies, TEAM-NB.

Moreover, all four organizations designated under the IVD Regulation are also ̶ or have recently been ̶ members of the association.

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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

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More from Geography

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• By David Ridley

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