Czech Republic medical device registration timeline
Source-linked clocksState Institute for Drug Control (SÚKL) 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 estimatesCzech Republic Medical Device Registration Process
Step-by-step SÚKL 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 SÚKL. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to SÚKL including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksSÚKL reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. SÚKL may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, SÚKL issues Czech Republic market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- Clinical investigation authorisation per MDR Art. 70(7)(b)/IVDR 66(7)(b); investigation cannot start without authorisation and must start within 1 year (§ 20(5) Law 375/2022)
- Art. 82 investigations notified 60 days before start; may start after 60 days, latest within 1 year (§ 22(3))
- ISZP annual confirmation within 1 year (reminder 30 days before; restoration within 6 months) (§ 25(2)); custom-made manufacturers notify 30 days before start, generic device groups 6 months (§ 8(4))
- Fee call within 15 days; non-payment stops the proceedings (UST-29)
Reviewed 2026-08-29. End-to-end totals remain planning estimates.