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.
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
15
Sep 21
Compulsory licenses: Italy takes a step forward with the new article 70-bis of the industrial property code
Law Decree No. 77 of 31 May 2021 introduced into the Italian Industrial Property Code Article 70-bis on compulsory licenses for medicinal products and medical devices in case of declaration of a state of emergency
15
Sep 21
European Court of Justice focuses on the requirements for the cross-border online sale of non-prescription medicines
On July 8, 2021, the European Court of Justice ruled on the interpretation of Directive 2001/83/EC in case C-178/20.
8
Sep 21
Artificial Intelligence and Machine Learning in Clinical Trials: Regulatory attempts by European and national authorities
In the last few years, use of Artificial Intelligence and Machine Learning systems in the performance of Clinical Trials has increased.
