Business types in Brno
Regulation in the Czech Republic
Czech Republic is in the EU / EEA, so the EU framework applies.
Regulator: European Commission (DG SANTE) with national competent authorities of EU/EEA Member States
Two EU regulations govern medical devices and IVDs in the EU/EEA; devices need CE marking after the conformity assessment route set by their risk class.
From the sourced EU MDR / IVDR entry, checked 29 October 2026. General information, not legal advice. Requirements for Czech Republic · All medical certifications
Frequently asked questions
Where in the Czech Republic are listed instrument companies located?
Most listed Czech companies are in the capital: the directory currently has more than 5 companies on its Prague city page, with a couple each in Kladno and Brno, out of 12 in the country. Prague listings may include distributors and representative offices of foreign brands as well as manufacturers.
When a Czech company offers to act as your EU importer or authorized representative, ask for its EUDAMED registration and a written mandate or supply agreement setting out who does which MDR tasks. See all listings on the Czech Republic country page.