Notified Bodies Apply For EU MDR/IVDR Designations Despite Document Shortfall

If there is a delay in appointing EU notified bodies under the new Medical Device and IVD Regulations, it will impact the whole sector's ability to comply in time. But nothing is quite ready.

EU Brussels

Notified bodies seem determined to make sure that they, at least, are not responsible for any delays in the implementation of the EU Medical Devices and IVD Regulations.

Despite the fact that none of the tools needed for the formal designation of notified bodies under the Medical Devices and IVD Regulations are yet available in final form, many...

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