EU health sector reforms: Italy mandates online device complaint reporting; France eases reporting of violence against c

From 22 July 2026, Italy’s Ministry of Health will require all public and private healthcare operators, pharmacies, general practitioners and paediatricians to submit complaints about medical devices covered by the EU Regulation 2017/745 through a new online platform, Nsis‑Dispovigilance. The system replaces email submissions, automatically integrates reports into ministry databases and mandates that complaints be filed within 30 days of the incident. An operational manual and SPID‑based authentication are provided to support users.

In France, a new decree implements the “Pradal” law on protecting health professionals by allowing professional orders and regional unions (URPS) to file criminal complaints on behalf of clinicians who have suffered assaults, with the victim’s consent. The measure aims to remove barriers that discourage reporting and to improve the capture of violence incidents in healthcare settings. The decree also outlines procedures for non‑regulated professions and signals ongoing work on additional reporting mechanisms.