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.
With Decision No. 2928 of 19 April 2022, the Council of State confirmed the legitimacy of the AIFA’s resolution modifying the supply regime of a medicinal product used for emergency contraception by removing the need for the medical prescription.
Through the EU Directive on Restructuring and Insolvency of 20 June 2019 (EUR 2019/1023, “Directive”), the European Union has imposed an obligation on its member states to offer a more attractive and flexible restructuring scheme in their respective local law. The initial deadline to do so had been 17 July 2021. Only a handful of countries (most notably Germany and The Netherlands) had implemented the Directive within the initial deadline, whilst the other countries made use of the possibility to ask for a one year extension.
These are the latest Employment updates in Italy. This update includes new rules in relation to digital platform workers and remote workers and a labor court decision on discriminating against ‘anti-vax’ employees.
With judgment No. 2149 dated 19 January 2022, the Court of Cassation acknowledged the liability of a manufacturer of medical devices for damages suffered by a patient due to their medical devices breaking during surgery.
On 23 March 2022, the “National Ethics Committee for trials conducted by public research organizations and other public organizations of a national nature” (“National Ethics Committee”) was established within the National Institute of Health (NIH) in accordance with the provisions of the decree of the Ministry of Health dated 1 February 2022. The National Ethics Committee was settled on 23 March at the Italian NIH to replace the Ethics Committee of the NIH, which has been in office until now.
On 16 February 2022, the Decree of the Ministry of Health dated 30 November 2021 governing the assignment for registration and commercial purposes of data relating to nonprofit clinical studies (“Decree”) was published in the Official Gazette. Said Decree repeals the previous Ministerial Decree dated 17 December 2004.
On 16 February 2022, the European Commission published the final version of Annex 21 to the Good Manufacturing Practice (GMP) Guidelines governing the importation of medicinal products, which will enter into force on 21 August 2022.
Baker McKenzie’s Sanctions Blog published the alert titled Italian Government amends foreign investment scrutiny in the context of the invasion of Ukraine on 30 March 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.