EU MDR + the German layer
MDR 2017/745 applies directly; the MPDG assigns BfArM, PEI and ZLG their roles — and there is no separate German CE marking.
Free field guide · PDF
Germany BfArM Medical Device Registration2026 Field Guide
No separate German CE mark — EU MDR applies directly. What Germany adds is the MPDG layer: BfArM, the DMIDS-to-EUDAMED registration handover, and German-language labelling.
- BfArM registration
- No fee
- Class IIa CE route
- 12–18 mo
- EUDAMED mandatory
- 28 May 2026
Sourced from BfArM guidance, the MPDG, and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — BfArM guidance, the MPDG, and verified 2026 publications.
DMIDS → EUDAMED handover
Four EUDAMED modules became mandatory on 28 May 2026 — and DMIDS data does not migrate. Actor and device data must be re-entered.
German-language labelling
Labelling and IFU must be in German (MPDG § 8). English-only documentation is the most common inspection finding for imported devices.
Sources & scope
- bfarm.de, BfArM DMIDS portal and FAQ (DMIDS-to-EUDAMED handover, registration practice).
- gesetze-im-internet.de, MPDG — Medical Device Law Implementation Act.
- 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. BfArM practice, EUDAMED transition deadlines, and fee ordinances change — professional review is required before business use.
Market Access Strategy Session
Germany on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your Germany route — notified-body selection, EUDAMED registration, and the German labelling and reimbursement tracks.
Professional review is required before business use.
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