16
Jan
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.
16
Jan
New procurement code and sub-threshold awarding: Contracting authorities are still free to use standard tendering procedures
Approved the possibility for contracting stations to employ standard selection procedures by publishing notices in awarding contracts for work, services, and supplies with values below the thresholds indicated the Public Procurement Code.
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.
3
Nov 23
Digitization in the new Public Procurement Code: New technological frontiers and artificial intelligence
The digitization of tendering procedures is one of the most important issues addressed by the new Public Procurement Code, which introduces systematic reorganization and significant changes.
