Denmark medical device registration timeline
Source-linked clocksDanish Medicines Agency (Danish Medicines Agency) 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 estimatesPlanning steps and estimates; these are not regulator deadlines.
Denmark Medical Device Registration Process
Step-by-step Danish Medicines Agency 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 Danish Medicines Agency. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Danish Medicines Agency including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksDanish Medicines Agency reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. Danish Medicines Agency may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Danish Medicines Agency issues Denmark market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- Clinical investigation decision for class I and non-invasive IIa/IIb no later than 45 days after validation (MDR Art. 70(5); § 17(3) BEK 1731/2025); substantial modifications processed in 38 days
- Ethics committees notify DKMA within 25 days of validation for supplementary-information requests, likewise DKMA (§§ 15-16 BEK 713/2022); expert-extension notice within 7 days for invasive IIa/IIb and III
- Distributor and specialty-retailer registration processed within 14 days of receipt (valid from the submission date)
Reviewed 2026-08-29. End-to-end totals remain planning estimates.