Official
Competent authority
National authority responsible for medical-device oversight.
2 linked sources
SÚKL · official source indexCzech Republic medical device regulatory sources
Start with the competent authority, submission surface, official forms, and source coverage we have verified for Czech Republic.
5 dimensions sourced5 official sources2026-08-13 reviewed
Official starting point
State Institute for Drug Control (SÚKL)
EUDAMED for MDR/IVDR actors/devices plus ISZP national notifications for specified roles
Coverage boundary
This is an official-source spine, not a completed market-access rulebook. It identifies where to begin and shows which dimensions still need detailed extraction.
Structured coverage
Nine regulatory research dimensions
Each status is source-bound. A located page is useful for research, but it does not turn adjacent requirements into verified facts.
Shared + national
Legislation & guidance
Primary law, regulation, or official implementation guidance.
3 linked sources
Official
Registration & submission
Official route used to register an operator or submit a device.
4 linked sources
Official
Official forms
Current authority forms, filing templates, or online form surface.
3 linked sources
Research needed
Label, IFU & language
Official surface for labeling, instructions for use, and language rules.
0 linked sources
Research needed
UDI & traceability
Official UDI, device identification, or traceability surface.
0 linked sources
Research needed
Post-market & vigilance
Incident reporting, vigilance, safety action, and recall surface.
0 linked sources
Official
Import & establishment
Importer, local operator, establishment, or market-entry surface.
3 linked sources
Research needed
Renewal & change
Renewal, variation, amendment, transfer, or discontinuation surface.
0 linked sources
Source highlights
What the reviewed surfaces indicate
- The current national basis is Act No. 375/2022 Coll.
- Distributors, service persons and custom-made manufacturers have national ISZP notification duties.
Primary evidence
Official sources
European Commission
Medical devices — national competent-authority contacts
Current EU competent-authority discovery and contact spine.
EUR-Lex
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
Shared EU/EEA IVD rule layer; national implementation deltas remain separate.
EUR-Lex
Regulation (EU) 2017/745 on medical devices
Shared EU/EEA medical-device rule layer; national implementation deltas remain separate.
European Commission
EUDAMED information centre
Shared EUDAMED layer; mandatory use of the first four modules began 28 May 2026.
State Institute for Drug Control (SÚKL)
Registration and Notification
Current official surface used as a bounded starting point; it is not a complete rule table.
Official source indexes in other markets
Other Europe markets
Austria
Belgium
Bulgaria
Denmark
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Kazakhstan
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