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Hungary’s New Designation Pushes EU Medical Device Notified Body Count To 50

 
• By Amanda Maxwell

Having 50 notified bodies under the Medical Device Regulation is a landmark achievement for the EU after a long and slow, journey to reach this point.

AUDIT word written on wood block

EU notified body numbers and capacity for medical device auditing is looking healthy as the region is now approaching the same number of notified bodies under its Medical Device Regulation as it had in 2017 under the former Medical Devices Directive.

In May 2017, the month that the Medical Device and IVD Regulations entered into force to eventually replace the medical devices directives, there were 55 EU notified bodies in total: EU member states (52); Switzerland (2); Australia (1) and the UK (5)

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