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9 Feb
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.
7 Feb
Digitization of Instructions for Use: the European Commission has endorsed a new Implementing Regulation on the use of electronic instructions for use (eIFUs) of medical devices
On December 14 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council relating to electronic instructions for use of medical devices.
7 Feb
New incentives from the Italian Government to promote telemedicine in pharmacies
As was recently demonstrated by the COVID-19 pandemic, the development of telemedicine has been an important tool in the containment of the disease.
4 Feb
Medical Devices Regulation: Note issued by the Ministry of Health to regulate the transition period
On November 12, 2021, the Ministry of Health published a note providing guidance on the provisions of Legislative Decree No. 46/1997 that shall still be considered applicable following the date of the application of Regulation (EU) 2017/745 on medical devices and the issuance of the legislative decrees envisaged by Article 15 of Delegation Law No. 53/2021.
4 Feb
IVD devices: Extension of timelines for the application of Regulation (EU) 2017/746
Regulation (EU) 2022/112 of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices was published on January 25, 2022.
4 Feb
Pharmacies managed by corporations and incompatibility with the exercise of the medical profession: Recent positions of the administrative courts
Administrative jurisprudence recently took up the issue of incompatibility between the management of a pharmacy and the performance of other activities in the health sector, as established by Article 7 of Law No. 362/1991.
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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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...
July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
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