Competent authority
authority.competent-authority
National Center for Public Health and Pharmacy (NNGYK)
NNGYK · structured requirements
🇭🇺 Hungary medical device regulatory data
Explore the medical device requirements currently available for Hungary, organized by topic and linked to official sources.
4 facts3 dimensions4 official sourceslatest verification 2026-08-13
Legal basis & guidance
Which current law, regulation, guidance, and transition provisions apply?
Official legal and guidance surface
legal-basis.official-surface
- Authority
National Center for Public Health and Pharmacy (NNGYK)
- SubmissionSurface
EUDAMED shared layer; current national operational form/portal still requires extraction
- VerifiedHighlights
- NNGYK's official tariff identifies national medical-device registration, change and certificate services.
- Caveat
A current consolidated national device-registration portal/form page was not located in this pass.
Reliance & recognition
Which foreign decisions or evidence can be reused, with what effect and conditions?
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-hungary
- Target
geo:hun
- SourceApproval
EU CE under MDR/IVDR
- EdgeType
Single Market Validity
- MarketAccessStrength
direct
- RegulatoryLayer
Product Marketing
- SameDeviceRequired
Yes
- LocalApplicationRequired
No
- TargetDecisionRetained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
Türkiye CE under aligned MDR/IVDR — customs union free circulation
reliance.reliance-edge-turkiye-ce-to-eu27-approval-turkiye-ce-mdr-ivdr-hungary
- Target
geo:hun
- SourceApproval
Türkiye CE under aligned MDR/IVDR
- EdgeType
Customs Union Free Circulation
- MarketAccessStrength
Direct With Local Obligations
- RegulatoryLayer
Product Marketing
- LocalApplicationRequired
No
- TargetDecisionRetained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- certificate duly issued by a Turkish notified body under aligned MDR/IVDR rules
Need to apply Hungary's requirements to a product?
Confirm the current NNGYK pathway, evidence, and local-role details for the actual device before filing.