EU Implementing/Delegated Acts Estimate Balloons From 80 To 118

A substantial amount of additional text will apply in the EU to the future regulation of medical devices and IVDs over and above what is in the new regulations. With 118 acts to draft, much work is still to come.

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Estimates of the number of implementing and delegated acts that will be necessary to execute the new EU Medical Device and IVD Regulations are growing.

There is a total of 118 implementing and delegated acts expected across the two new EU regulations, according to figures...

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