On April 23, Law No. 53 of April 22, 2021, “Delegation to the Government for the transposition of European directives and the implementation of other European Union acts,” was published in the Official Gazette (“Delegation Law”).

The European Commission has published an interesting infographic showing which logical path should be followed in order to understand whether a software can be qualified as a medical device.

The National Coordination Center of Territorial Ethics Committees for clinical trials on medicines and medical devices (“National Coordination Center”) has drawn up guidelines for the collection of informed consent (“Guidelines”) for participation in clinical trials, pursuant to Legislative Decree No. 211 of June 24, 2003 and Regulation (EU) 536/2014.

More than 2 months ago the Italian Government issued certain measures[1] with the purpose of expanding its power to veto or impose conditions on acquisitions of, or other transactions involving, Italian targets operating in certain strategic sectors.

On 3 April 2020, to prioritize the fight against the Covid-19 pandemic crisis, the European Commission adopted a proposal to (i) postpone the date of application of Regulation (EU) 2017/745 on medical devices (“MD Regulation”) (scheduled for 26 May 2020) by one year and (ii) deviate from the normal conformity assessment procedures of medical devices in cases of need and emergency.