Italy · Ministry of Health · Diagnostics (IVD)
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
7 requirements
Application fee
-
CE marking under the EU IVD regulation is the market entry route. Until the EU database modules for registration work, Italy keeps its older national registration duties for in vitro diagnostics. Higher-risk list devices and self-tests need a prior notice with label and instructions. Italian-language information and distributor registration also apply. Any CE-marked in vitro diagnostic device placed on the market or put into service in Italy.
1. CE marking under the EU IVD regulation; 2. Register manufacturer and devices; 3. Prior notice for list devices and self-tests; 4. Distributor registration.
Outcome: The manufacturer, its devices and distributors are registered with the Ministry of Health.
Legal basis: Legislative Decree 138/2022 (national rules on top of Regulation (EU) 2017/746); Legislative Decree 332/2000, article 10, 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 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.