15
Nov 21
AGCM finds no abuse in diagnostic imaging device manufacturers’ refusal to provide downstream competitors access to information for maintenance services
On March 30, 2021, the Italian Competition Authority closed an investigation it had opened in 2018 against three manufacturers of high-end diagnostic imaging devices.
15
Nov 21
The Consolidated Act on Rare Diseases is finally approved
After three years, Italy has finally adopted its first law on rare diseases. On November 3, 2021, the Italian Senate unanimously approved the Consolidated Act on Rare Diseases, or “Testo Unico sulle malattie rare”.
12
Nov 21
Health data and digital healthcare: MedTech Europe Recommendations
On June 16, 2021, the European trade association representing the medical technology industries named MedTech Europe published a document containing recommendations for maximizing benefits from use of health data collected via medical devices.
<!--:it-->The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the applicability of MDR requirements to 'legacy devices' and 'old' devices<!--:-->
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
8
Oct 21
As of October 15, 2021, in Italy, no salary without a Green Pass
The Italian government has enacted what is known as the “Green Pass bis Decree”, introducing urgent measures to ensure the safe performance of public and private work through the extension of the scope of application of COVID-19 green certification and the strengthening of the screening system.