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.
1
Jul 21
Artificial intelligence and medical devices: The potential impact of the proposed Artificial Intelligence Regulation on medical device software
The recent proposal for a regulation on artificial intelligence (the Artificial Intelligence Regulation) might add a new piece to the regulatory puzzle governing medical device software and other medical devices that incorporate software based on AI algorithms.
10
Jun 21
Mutual recognition for medical devices between the EU and Switzerland ceased to apply on 26 May 2021: what is the impact for the sector?
Interview to Anna Gottret, Alisa Burkhard and Sophie Winkler of Flying Lawyers, Zurich
10
Jun 21
New FAQ on the European Medical Device Nomenclature (EMDN) to support the EUDAMED
The Medical Device Coordination Group (MDCG), composed of representatives of all Member States and a representative of the European Commission, endorsed a new FAQ on the European Medical Device Nomenclature (EMDN)
