Portolano Cavallo

Life Sciences


13 Dec 21
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the operational and practical implementation of Articles 13&14 and other related obligations for importers and distributors under MDR and IVDR Regulations
27 Oct 21
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
19 Oct 21
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
29 Sep 21
EU pharmaceutical strategy: today the Commission launched a public consultation on the revision of the EU general pharmaceuticals legislation (open until December 21, 2021)
4 Aug 21
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
25 Jun 21
Clinical trials: EMA launches public consultation on draft guideline for using computerized systems and electronic data
9 Jun 21
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 (EUDAMED)
25 May 21
The Italian Data Protection Authority published guidelines on the role of the Data Protection Officer in public entities: important news for hospitals and healthcare facilities
4 May 21
European Health Union: Commission publishes open public consultation on the European Health Data Space
22 Apr 21
Clinical Trial Regulation: Clinical trial EU Portal and Database, essential for the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022
19 Jan 21
Dematerialization of prescriptions: Ministerial Decree allowing e-prescriptions for drugs not reimbursed by the NHS has been published in the Italian Official Journal.
21 Dec 20
Telemedicine: Italian State-Regions Conference issues "National indications for the provision of telemedicine services" to implement telemedicine services in Italy
8 Oct 20
Ecommerce of medicinal products: according to the European Court of Justice, certain legislative restrictions imposed by the Member State where medicines are offered to public also apply to the online pharmacy established in another Member State
9 Jul 20
Italian Medicines Agency and medicines shortage: published Q&A for MAHs on notification of shortage and any temporary or permanent interruption in the marketing of medicines
27 Apr 20
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
6 Apr 20
Medical Devices Regulation: European Commission adopted a proposal to postpone the date of application of the MDR by one year, until 26 May 2021
20 Mar 20
German Constitutional Court declared that Act of Approval to the Agreement on a Unified Patent Court is void
5 Mar 20
Feed intended for particular nutritional purposes: in the EU Official Journal the Commission Regulation (EU) 2020/354, establishing a list of intended uses of feed for particular nutritional purposes and repealing the previous Directive 2008/38/EC
8 Feb 19
New safety features for most prescription medicines and some OTC medicines supplied in the EU
4 Feb 19
EMA has launched a public consultation on key principles for the electronic product information of EU medicines
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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