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29 Apr 21
European Delegation law to implement the Medical Devices Regulations
On April 23, Law No. 53 of April 22, 2021, “Delegation to the Government for the transposition of European directives and the implementation of other European Union acts,” was published in the Official Gazette (“Delegation Law”).
15 Apr 21
Software as Medical Device
The European Commission has published an interesting infographic showing which logical path should be followed in order to understand whether a software can be qualified as a medical device.
14 Oct 20
Clinical trials: National Coordination Center of Ethics Committees issues Guidelines for the collection of informed consent
The National Coordination Center of Territorial Ethics Committees for clinical trials on medicines and medical devices (“National Coordination Center”) has drawn up guidelines for the collection of informed consent (“Guidelines”) for participation in clinical trials, pursuant to Legislative Decree No. 211 of June 24, 2003 and Regulation (EU) 536/2014.
11 Jun 20
Acquisitions of companies involved in the medical devices business fall under the Italian foreign investment control
More than 2 months ago the Italian Government issued certain measures[1] with the purpose of expanding its power to veto or impose conditions on acquisitions of, or other transactions involving, Italian targets operating in certain strategic sectors.
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
9 Apr 20
Medical Devices Regulation: EU Commission proposes a one year postponement of the application date
On 3 April 2020, to prioritize the fight against the Covid-19 pandemic crisis, the European Commission adopted a proposal to (i) postpone the date of application of Regulation (EU) 2017/745 on medical devices (“MD Regulation”) (scheduled for 26 May 2020) by one year and (ii) deviate from the normal conformity assessment procedures of medical devices in cases of need and emergency.
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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