Portolano Cavallo

Life Sciences


5 Apr
Regulation (EU) 2023/607 extending CE certificates for medical devices and in vitro devices came into force
Regulation (EU) 2023/607 extended the duration of CE certificates for legacy devices and the relevant period during which such devices can be placed on the market or put into service, previously scheduled to expire on May 26, 2024.
5 Apr
Advertising of medical devices and in vitro diagnostic medical devices to the general public: When ministerial authorization is not required
On March 18, two decrees of the Ministry of Health were published in the Official Gazette, both dated January 26, 2023.
5 Apr
In the United States, Amazon launched RxPass, a subscription for online purchase of prescription drugs: Could it work in Italy?
A few weeks ago, the company introduced a new subscription service that allows subscribers to purchase more than fifty different prescription medicines for a low fixed months fee. Why this would be prohibited in Italy.
4 Apr
Decentralized clinical trials: Recommendation paper for the implementation of uniform procedures in the European Union published
On December 13, the long-waited European Recommendation paper on decentralised elements in clinical trials was finally published, to provide Member States further and more detailed guidance on the implementation of procedures for conducting trials outside of clinical trial centers.
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 devices entered into force following publication on EU's Official Journal
2 Feb
Transparency and responsibility regarding medical-scientific information on the web
On September 28, two international pharmaceutical industry associations, the IFPMA and the EFPIA, published a Joint Note for Guidance on social media and digital channels to guide the work of pharmaceutical companies that use the web to provide doctors and patients with information about their products and the illnesses they are intended to treat.
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.

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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