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.
The bill on the “Annual Market and Competition 2021”, approved by the senate on 30 May 2022 and currently under examination by the Chamber of Deputies, provides for the amendment of Article 15 of Law No. 219/2005, governing the Italian transfusion system and the production of blood-derived medicines.
On 20 June 2022, the new national pharmacovigilance network, which ensures the collection, management and analysis of suspected adverse reaction reports of medicines in Italy, became operative.
With Judgement No. 3278/2022, the Council of State confirmed the legitimacy of the decision by which the Italian Medicine Agency declared the forfeiture of an MA for failure to market the drug pursuant to Article 38, paragraph 7 of Legislative Decree No. 219/2006.
Baker McKenzie’s Sanctions Blog published the alert titled Italy — Amendments to the foreign investment review become permanent with some changes on 31 May 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
On 24 May 2022, the bill on ‘Transparency rules on relationships between manufacturing companies, healthcare professionals and organizations’ (“Sunshine Act”) was finally approved. The Sunshine Act will enter into force after its publication in the Official Gazette.
On 16 April 2022, the Decree of the Ministry of Health dated 31 March 2022 establishing the national network for device-vigilance and the supporting information system was published in the Official Gazette.
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.
On 13 May 2022, the AIFA’s regulation, which amends the procedures for the exercise of the right to documentary and simple civic access and introduces the criteria and procedures for the exercise of the general civic access, was published in the Official Gazette.