Germany medical device registration timeline
Source-linked clocksFederal Institute for Drugs and Medical Devices (BfArM) 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 estimatesGermany Medical Device Registration Process
Step-by-step BfArM 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 BfArM. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to BfArM including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksBfArM reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. BfArM may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, BfArM issues Germany market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- Digital health applications (DiGA) fast track: BfArM assessment within 3 months of a complete application (§ 139e SGB V)
- No national registration review clock for conventional devices; EUDAMED product registration becomes mandatory from 28 May 2026 (legacy devices by 28 Nov 2026)
- Clinical investigation § 42 MPDG: rejection of a substantial modification communicated within 37 days (+7 with experts)
Reviewed 2026-08-29. End-to-end totals remain planning estimates.