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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.
9 Feb 22
European Clinical Trials Regulation is now applicable: Recent updates
On January 31, 2022, EU Regulation 536/2014 on clinical trials of medicinal products for human use (“Clinical Trials Regulation” or “CTR”) finally went into effect more than seven years after its approval, but Italy is not yet ready for its application.
1 Jul 21
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.
7 Jun 21
EU regulations on medical devices and the GDPR: first step forward a necessary coordination
In the wake of application of the European medical device regulation (EU Regulation No. 745 of 2017), occurred on May 26, Italy is taking its first steps toward adjusting its national regulatory framework.
9 Apr 21
The “Pharmacy of Services” becomes more and more real
In recent months, under the pressure of the Covid-19 emergency, pharmacies have become more and more involved in the delivery of healthcare services to patients, in support of formal healthcare facilities and operating under the umbrella of the NHS.
18 Feb 21
Telemedicine: The New National Guidelines
Healthcare services provided remotely are officially a part of the National Healthcare Service (“NHS”), now that the State-Regions Conference has approved the document entitled “National guidelines for the provision of telemedicine services,” drafted by the Ministry of Health (hereinafter the “Guidelines”).
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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