European Delegation law to implement the Medical Devices Regulations
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”).
Software as Medical Device
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.
Clinical trials: National Coordination Center of Ethics Committees issues Guidelines for the collection of informed consent
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.
Acquisitions of companies involved in the medical devices business fall under the Italian foreign investment control
More than 2 months ago the Italian Government issued certain measures 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.
Medical Devices Regulation: Regulation 2020/561 has been published in the Official Journal of the European Union postponing the date of application of MDR by one year to 26 May 2021
Medical Devices Regulation: EU Commission proposes a one year postponement of the application date
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.