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Portolano Cavallo Life Sciences Blog  / Software As Medical Device
14 Sep
The AI Act: What will the impact be on the medical device industry?
The European Parliament approved the “AI Act” (June 14, 2023), a proposal for a regulation providing a uniform legal framework for the use of artificial intelligence in the EU.
6 Jul 22
Telemedicine: When is software a medical device? The Court responds
On February 23, 2012, the Regional Administrative Court of Lombardy—seat of Milan—issued a ruling on the qualification as a medical device of a software platform used to provide healthcare services remotely.
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.
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”).
6 Jun 19
Artificial intelligence software: FDA news
On April 2, 2019, a discussion paper describing a proposal for a regulatory framework for modifications to Artificial Intelligence-based medical devices that are already on the market, was published by the Food and Drug Administration (FDA), in view of the future formulation of guidelines that relate to this issue.
1 Dec 17
EUCJ’s ruling on the classification of software as medical devices
According to a very recent ruling of the European Court of Justice (EUCJ), (C-329/16, Snitem v. Syndicat national de l’industrie des technologies médicales, published on 7 December 2017), software with at least one function that makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device, even if that software does not act directly in or on the human body.
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, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
June 30, 2023
Payback for medical devices: on June 28 Italian parliament approved the Law which, among other things, extends the deadline for the payment of the amount reduced by 52% from June 30th to Jul...
June 20, 2023
Clinical investigations on medical devices: four ministerial decrees setting out procedures for submitting applications/notifications and requirements for facilities and assessing persons, i...
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