MDR & IVDR national implementation: Italy

In August 2022, Italy published the national law implementing the EU Regulations on medical devices and IVD medical devices.

Since September 28, 2022, Legislative Decrees No. 137 (Medical Devices) and No. 138 (in vitro diagnostic Medical Devices) on the adaptation of the MDR (EU) 2017/745 and IVDR (EU) 2017/746 in Italy, apply to all economic operators. The Decrees . . .


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