Hungary medical device registration timeline
Source-linked clocksNational Public Health and Medical Officer Service (NNGYK) 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 estimatesHungary Medical Device Registration Process
Step-by-step NNGYK 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 NNGYK. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to NNGYK including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksNNGYK reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. NNGYK may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, NNGYK issues Hungary market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- National registration/notification deadlines follow the general administrative procedure code (Ákr. 2016. CL.)
- Clinical investigation validation: formal validity reviewed within 10 days (+5 extension), cure 10 days (+20); the procedure lapses without a response; substantive assessment 45 days (+20 with expert body)
- PMCF studies notified at least 30 days before start; substantial modifications start earliest 38 days after notification (+7)
- The IVD page still cites the repealed Ket. — treat as outdated; Art. 78 multicentre single-application procedures are not available in Hungary before 2027
Reviewed 2026-08-29. End-to-end totals remain planning estimates.