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Italy | Medical devices, in the Official Gazette the legislative decrees for the adaptation of the national regulatory framework to European regulations

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Legislative decrees 137 and 138 of 5 August 2022 published in the Official Gazette of 13 September 2022 have the purpose of ensuring that all the subjects involved (notified bodies, economic operators and health professionals) adapt to the provisions dictated by the Regulations. (EU) 2017/745 and 2017/746. 

The decrees on medical devices govern aspects of national competence in continuity with the Legislative Decree 46/97, 507/92 and 332/2000, establishing among other things the linguistic requirements for the label and for the instructions for use, confirming the registration obligation for manufacturers of customized devices and distributors, providing indications for advertising and online sale of devices, defining criteria for the granting of authorizations in derogation in the event of deficiencies on the market and finally defining a sanctioning system for violations of the conduct provided for in the Regulations.


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