Italy medical device registration timeline
Source-linked clocksItalian Ministry of Health (MoH) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — EU MDR classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(Self-declaration (no notified body)) MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock | 0 days | 6-9 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesItaly Medical Device Registration Process
Step-by-step MoH registration process. Total estimated timeline: 6-9 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by MoH. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to MoH including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksMoH reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. MoH may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, MoH issues Italy market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- Clinical investigation authorisation (class III, invasive IIa/IIb, Art. 74(2)): within 45 days of validation (+20 with experts) (Art. 16(2) D.Lgs. 137/2022)
- Class I / non-invasive IIa/IIb: tacit start 30 days after validation absent rejection, with a favourable ethics opinion required
- MDR Art. 59(1) derogation decided within 60 days (Art. 11(7)); IVDR Art. 54(1) likewise via Art. 8(6) D.Lgs. 138/2022
Reviewed 2026-08-29. End-to-end totals remain planning estimates.