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Portolano Cavallo Life Sciences Blog  / Software As Medical Device
6 Jul
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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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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