EU MDR + the Italian layer
MDR 2017/745 applies directly; Legislative Decrees 137/2022 and 138/2022 designate the Ministry of Health and set the national rules — no Italian CE mark, no pre-market approval.
Free field guide · PDF
Italy Medical Device Registration2026 Field Guide
No Italian CE mark — EU MDR applies directly. What Italy adds is the layer that decides whether you can actually sell: BD/RDM registration and the Repertorio, the CND code, Italian-language labelling, and payback-aware regional procurement.
- BD/RDM registration
- €0
- Class IIa CE route
- 12–18 mo
- BD/RDM filing (reported)
- 30–45 days
Sourced from the Ministry of Health, Legislative Decrees 137/2022 & 138/2022, and verified 2026 publications.
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What's inside
Seven pages, zero fluff
Every figure in this guide traces to a named source — the Ministry of Health, the 2022 adaptation decrees, and verified 2026 publications.
BD/RDM + Repertorio
National registration is free — but without a BD/RDM number, a Repertorio listing and the right CND code, you are invisible to public buyers and tenders.
Regional buying + the payback
Twenty regional markets and Consip frameworks — plus a payback mechanism that makes suppliers repay a share of public overspend. Price Italy with it from day one.
Sources & scope
- salute.gov.it, Ministry of Health — BD/RDM and Repertorio registration practice, advertising authorisations.
- gazzettaufficiale.it, Legislative Decrees No. 137/2022 and No. 138/2022 — Italian MDR/IVDR adaptation.
- eur-lex.europa.eu, Regulation (EU) 2017/745 (MDR), Regulation (EU) 2023/607, Commission Decision (EU) 2025/2371.
This guide is market-access intelligence, not regulatory or legal advice. Ministry of Health practice, the BD/RDM–EUDAMED interaction, and the payback position change — professional review is required before business use.
Market Access Strategy Session
Italy on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your Italy route — notified-body selection, EUDAMED and BD/RDM registration, CND assignment, and a payback-aware regional tender strategy.
Professional review is required before business use.
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