EU MDR + the French layer
MDR 2017/745 applies directly; the Public Health Code adds ANSM notification, French labelling and vigilance — there is no French pre-market approval.
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France ANSM Medical Device Registration2026 Field Guide
No French approval to win — EU MDR applies directly. What France adds is the ANSM notification layer, French-language labelling, and a reimbursement system where legal and paid are two different battles.
- Pre-market approval
- None
- Class IIa CE route
- 12–18 mo
- LPPR listing after CE
- 18–36 mo
Sourced from ANSM guidance, the Public Health Code, HAS/CNEDiMTS method, and verified 2026 publications.
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What's inside
Six pages, zero fluff
Every figure in this guide traces to a named source — ANSM guidance, the Public Health Code, HAS/CNEDiMTS method, and verified 2026 publications.
ANSM communication → EUDAMED
Class I and custom-made makers declare their activity; IIa/IIb/III actors notify ANSM — and ANSM treats EUDAMED registration as equivalent.
Reimbursement: the LPPR route
CE marking is not payment: HAS/CNEDiMTS grades benefit (SA) and added value (ASA), CEPS negotiates the tariff, the LPPR listing follows.
Sources & scope
- ansm.sante.fr, ANSM market-surveillance mission and field-safety-notice guidance (declaration and notification obligations, EUDAMED equivalence).
- eur-lex.europa.eu, Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), Regulation (EU) 2023/607, Commission Decision (EU) 2025/2371.
- has-sante.fr, HAS/CNEDiMTS assessment method (SA/ASA), CEPS tariff negotiation and the LPPR listing process.
This guide is market-access intelligence, not regulatory or legal advice. ANSM practice, EUDAMED transition deadlines, and reimbursement schemes change — professional review is required before business use.
Market Access Strategy Session
France on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your France route — notified-body selection, EUDAMED registration, French labelling, and the HAS/CEPS reimbursement track.
Professional review is required before business use.
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