In vitro diagnostic medical devices.

Government Order No. 56/2015 Sb. /PDF 7 MB/, on technical requirements for diagnostic medical devices.

List of bodies authorised to carry out conformity assessment activities for in vitro diagnostic medical devices

• AO 224 - Institute for Testing and Certification, a. s.

European Union

• European Union website
• Notified persons in the EU
• Harmonised standards

Czech translation of the Directive - 31998L0079
Compiled version of Directive 31998L0079