16
Jan 24
Software medical devices in combination with hardware: The new MDCG guidelines
Medical device softwares (“MDSW”) that work in combination with hardware or hardware components to achieve their medical purposes: this is the topic of the guidelines issued by the MDCG-4, addressing manufacturers directly in an effort to provide regulatory guidance.
8
Nov 23
Digital therapeutics: A bill for regulation in Italy
Bill 1208 “Provisions on digital therapies” was presented in June 2023: the document is designed to regulate in Italy new technologies that offer therapeutic interventions guided by advanced software programs, with a focus on reimbursement.
5
Apr 23
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.
