Italy
Italy is one of the main European markets for medical devices, with a highly regulated sector and a strong presence of specialized companies.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Ministry of Health – Directorate General for Medical Devices and Pharmaceutical Services.
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Registration Process – Step by Step
| Phase | Estimated Timeframe | Required Documentation |
| Preparation | 2–4 months | Technical dossier, ISO 13485 certifications, CE mark |
| Registration | 1–2 months | Registration in the Ministry’s database |
| Evaluation | 3–6 months | Document review and possible requests for clarifications |
| Approval | 1 month | Official inclusion in the database |
Specific Local Requirements
| Language | Documentation in Italian. |
| CE Marking | Mandatory for all devices. |
| National Database Registration | Required for commercialization. |
Challenges and Operational Advice
- Complex regulations: Compliance with EU MDR 2017/745 is necessary.
- Detailed registration process: Requires high-quality documentation.
Why Choose ISEMED
- REGULATORY EXPERTISE
Specialized support for Italian regulations. - COMPREHENSIVE ASSISTANCE
From document preparation to registration.
FAQ
- Is a local representative required? No, but CE marking is mandatory.
- Documentation language? Italian.
- Registration duration? Unlimited, unless regulatory updates occur.