The Department of Planning and Organization of the National Health Service (Il Dipartimento della programmazione e dell'ordinamento del Servizio sanitario nazionale) is the regulatory agency within the Italian Ministry of Health that deals regulating pharmaceuticals, medical devices and other health products. According to the constitutional law n. 3 of 18 October 2001, the department develops and monitors quality assurance systems, coordinates health policies, authorizes and controls medicines, medical devices and other health products, as well as legal medical activities.
Within it, the Directorate General for Medical Devices, Pharmaceutical Services and Safety in Healthcare (La Direzione generale dei dispositivi medici, del servizio farmaceutico e della sicurezza delle cure svolge) deal with the implementation of medical device regulations, preventing and dealing with clinical risk, regulating the advertising of medical products and providing medical-legal consultancy to state institutions.
Some of the most important European regulations for medical devices in the EU are:
- CONSOLIDATED Medical Device Directive (93/42/EEC)
- CONSOLIDATED Active Implantable Medical Devices Directive (90/385/EEC)
- View as web page
- Personal Protective Equipment Directive (89/686/EEC)
A full list of EU regulations can be found here.
Medical Device Associations in Italy: