Italy · Ministry of Health · Medical devices
Review target
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Not published
Legal time limit
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Not published
Steps
4
3 requirements
Application fee
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In exceptional cases of need and urgency, the Ministry of Health can allow a specific device on the Italian market even though its conformity assessment is not done or not finished, if its use is in the interest of public health or patient safety. The Ministry decides within 60 days. The authorisation is time-limited. A device that is indispensable for public health or patient safety, with no suitable CE-marked alternative on the market.
1. Need signalled by health institutions; 2. Manufacturer request; 3. Ministry assessment; 4. Decision (60 days).
Outcome: A time-limited national authorisation, possibly with conditions, or a refusal.
Legal basis: Legislative Decree 137/2022, article 11 (devices); Legislative Decree 138/2022, article 8 (in vitro diagnostics); articles 59 and 54 of the EU device regulations.
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).
About 60 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Decisionlaw. Ministry decision on the request. This is an official target, not an actual review time. | 60 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Italy: National registration and duties for medical devices, National registration and duties for in vitro diagnostic devices. 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.