Italy Directorate General for Medical Devices
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) deals 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.
A list of EU regulations can be found here on our website.
Contact details:
Medical Device Associations in Italy:
Related services:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR Compliance Consulting for Cosmetic and Aesthetic Products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies