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The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
15 Sep
4. 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.
15 Sep
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
8 Sep
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
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
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)
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

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October 19, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
September 29, 2021
EU pharmaceutical strategy: today the Commission launched a public consultation on the revision of the EU general pharmaceuticals legislation (open until December 21, 2021)
August 4, 2021
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
June 25, 2021
Clinical trials: EMA launches public consultation on draft guideline for using computerized systems and electronic data
June 9, 2021
The Medical Device Coordination Group endorsed new FAQ on the European Medical Device Nomenclature (EMDN), that aims at supporting the functioning of the European database on medical devices...
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