28
May
Medical device payback: The Regional Administrative Court of Lazio rejects suppliers’ appeals
In a series of rulings issued in May 2025, the Regional Administrative Court of Lazio dismissed the appeals filed by medical device suppliers challenging the payback mechanism.
24
Feb
Budget law 2025: News for the healthcare sector
Annual budget laws bring numerous changes that also affect the healthcare sector. Let's look at the main novelties.
11
Jun 24
Medical devices and in-vitro medical devices: News and forthcoming provisions
In recent days there have been developments in the regulatory framework for medical devices and in-vitro medical devices via the proposal of the European Commission for the amendment of the MDR and the IVDR and the new guidance of the MDCG.
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.
14
Sep 23
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.
12
Sep 23
Clinical investigation of medical devices: implementation rules set out in Italy
In Italy, the process of establishing national regulations for clinical investigation of medical devices continues: in June, four new decrees were published, dealing with the modalities for submitting clinical investigation applications and communications according to the national procedure.
