Poland medical device registration timeline
Source-linked clocksOffice for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) 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 estimatesPoland Medical Device Registration Process
Step-by-step URPL 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 URPL. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to URPL including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksURPL reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. URPL may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, URPL issues Poland market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- Clinical investigation Art. 70: validation + 45-day assessment; substantial modification Art. 75: validation + 38 days; extensions +20/+7 (Art. 34 Ustawy o wyrobach medycznych)
- Bioethics opinion within 45 days (Art. 31(2)); IVDR Art. 66(2): validation + 45 days (Art. 42)
- Free-sale certificate within 15 working days (Art. 30); register entries within 7 days of a complete application and updates within 7 days of a change (Arts. 20, 25)
- Legacy notification completion: 14/30 days (Art. 139(11))
Reviewed 2026-08-29. End-to-end totals remain planning estimates.