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On 5 May 2022, the Council of Ministers preliminarily approved the bill to adapt the Italian legislation to the provisions of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The bills are currently being examined by the competent committees of the Italian Parliament.

From 26 May 2022, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has applied.
• The main changes introduced by the IVDR include (i) a new classification of devices, (ii) new conformity assessment procedures that differ according to the risk class and the specific characteristics of the device, (iii) reinforced requirements relating to clinical evidence aimed at demonstrating compliance with the safety and performance requirements of the device, (iv) the introduction of post-marketing follow-up obligations for manufacturers aimed at updating the performance evaluation throughout the life cycle of the device, (v) the provision of new obligations for manufacturers, authorized representatives, importers and distributors, and (vi) the obligation for manufacturers to appoint a person responsible for regulatory compliance.

On 16 February 2022, the Medical Device Coordination Group approved a new document to provide guidance to Notified Bodies on the appropriate way to carry out surveillance activities on CE-marked devices in accordance with the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC, which, by virtue of the provisions of Article 120(3) of Regulation EU 745/2014, can be marketed until 26 May 2024.