Norway medical device registration timeline
Source-linked clocksNorwegian Medical Products Agency (DMP) 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 estimatesNorway Medical Device Registration Process
Step-by-step DMP 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 DMP. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to DMP including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksDMP reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. DMP may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, DMP issues Norway market authorization certificate.
- EU/EEA Authorized Representative (for non-EEA manufacturers)
- Clinical investigation validation: feedback within 15 days of receipt; if invalid, 10 days to comment (+20); final validity within 10 days after resubmission
- Assessment: decision within 45 days of validation, clock frozen awaiting sponsor information, +20 with experts
- Transitional MDD rules until EUDAMED is mandatory: notification at least 60 days before start; class III/implantable/long-term invasive IIa/IIb start 60 days after notification unless objected
- End-of-investigation notification within 15 days; final report within 1 year
Reviewed 2026-08-29. End-to-end totals remain planning estimates.