SUKL
State Institute for Drug Control
About
SUKL is the Czech competent authority for medical devices, responsible for market surveillance, vigilance, and enforcement under the EU MDR framework.
Regulatory Details
Regulatory FrameworkEU MDR 2017/745 (Czech implementation)
Device ClassificationClass I, Class IIa, Class IIb, Class III
Jurisdiction TypeNational
Country🇨🇿 Czech Republic
StatusActive