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5 Feb 20
Class I medical device manufacturers may benefit from the transitional period under the MDR
On December 17, a corrigendum to Medical Device Regulation (MDR) 745/2017 was approved by the European Parliament that allows certain devices classified in Class I under Directive 93/42/EEC to benefit from the transitional period provided by the MDR.
17 Dec 19
EU commission publishes a new version of the draft Q&A on the application of the clinical trials regulation
In November 2019, the European Commission published a draft version of the answers to the numerous questions (“Q&A”) raised by stakeholders relating to the implementation of the rules laid down in Regulation (EU) No. 536/2014 on clinical trials.
16 Dec 19
Regional Administrative Court of Tuscany: recent judgment on biosimilars
n November 26, 2019, the Regional Administrative Court of Tuscany (Tribunale Amministrativo Regionale – “T.A.R.”, “Court”) ruled on the request for the invalidation of the Regional Council of Tuscany Resolution No. 457/2019 (“Resolution”) concerning the procedures for the supply and use of biosimilars in Tuscany.
13 Dec 19
News about advertising medical devices on Facebook: updates from the Ministry of Health
On October 24, 2019, the Ministry of Health published an addendum to the guidelines on the advertising of medical devices, in vitro diagnostic medical devices and medical-surgical devices (collectively “Medical Devices” or “MD”) on Facebook (the “Guidelines”).
12 Dec 19
Pharmaceutical trademarks: the proof of genuine use and proper reason for non-use
In its decision issued on 3 July 2019 in Viridis, Case C-668/17 (the “Decision”), the Court of Justice of the European Union (“CJEU”) ruled that the lengthy time necessary to complete a clinical drug trial is not a proper reason to prevent the prematurely registered trademark from being revoked for non-use.
12 Dec 19
New European Guidance on the qualification and classification of software as medical devices
In October 2019, the European Commission’s Medical Devices Coordination Group (MDCG) published a new guidance on the qualification and classification of software as medical devices (MDSW) under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) (the “Guidance”).
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 news, insights 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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March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
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