Italy · Ministry of Health · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
11 requirements
Application fee
-
CE marking under the EU rules is the market entry route. On top of it, Italy requires registration with the Ministry of Health. Until the EU database modules become mandatory, registration duties are met in the national database, and companies may choose the national database or the EU database. Italian-language information and national post-market duties also apply. Any CE-marked medical device, other than custom-made devices, that is placed on the market or put into service in Italy.
1. CE marking under the EU regulation; 2. Register manufacturer and devices; 3. Device data for classes IIa, IIb and III; 4. Distributor registration; 5. Post-market duties.
Outcome: The manufacturer, its devices and distributors are registered with the Ministry of Health, so that the devices can be supplied in Italy.
Legal basis: Legislative Decree 137/2022 (national rules on top of Regulation (EU) 2017/745); Legislative Decree 46/1997, article 13, as a transitional rule.
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Italy: Exceptional national authorisation of a device without completed conformity assessment. See all routes on the Italy page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.