Competent authority
authority.competent-authority
State Institute for Drug Control (SÚKL)
SÚKL · structured requirements
🇨🇿 Czech Republic medical device regulatory data
Explore the medical device requirements currently available for Czech Republic, organized by topic and linked to official sources.
5 facts4 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
State Institute for Drug Control (SÚKL)
- SubmissionSurface
EUDAMED for MDR/IVDR actors/devices plus ISZP national notifications for specified roles
- VerifiedHighlights
- The current national basis is Act No. 375/2022 Coll.
- Distributors, service persons and custom-made manufacturers have national ISZP notification duties.
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
- SubmissionSurface
EUDAMED for MDR/IVDR actors/devices plus ISZP national notifications for specified roles
- VerifiedHighlights
- The current national basis is Act No. 375/2022 Coll.
- Distributors, service persons and custom-made manufacturers have national ISZP notification duties.
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-czechia
- Target
geo:cze
- 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-czechia
- Target
geo:cze
- 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 Czech Republic's requirements to a product?
Confirm the current SÚKL pathway, evidence, and local-role details for the actual device before filing.