All posts by : Andrea Valoti

The National Labor Inspectorate (INL) and the Conference of Regions have issued critical clarifications regarding workplace machinery and compliance with Italian safety regulations, specifically Legislative Decree 81/08.

Questi cambiamenti interesseranno principalmente i responsabili della sicurezza, i gestori delle strutture e i valutatori del rischio che si occupano di mantenere i sistemi di protezione contro i fulmini.

Targeted toward professionals such as tree surgeons, landscapers, and arborists, the guidelines serve as a key reference for ensuring safety in tree-related operations.

These updates aim to enhance the designation process of notified bodies under EU Regulations 2017/745 (MDR) and 2017/746 (IVDR).

L’appello, delineato nel loro documento dettagliato, sottolinea i potenziali benefici per i pazienti, gli stati membri dell’UE e l’industria dei dispositivi medici nel suo complesso.

Key stakeholders, including MedTech Europe, AESGP, COCIR, EAAR, EUROM, and FIDE, have jointly published a discussion paper outlining a vision for a more efficient, patient-centered governance structure.

The primary objective of the explanatory note is to establish and share common directions and guidelines among supervisory bodies, as specified in Article 13 of Legislative Decree 81/08.

Released on January 29th, 2025, the document is set to introduce new regulatory standards aimed at ensuring the safety, effectiveness, and quality of medical devices that incorporate artificial intelligence (AI).