List of medical devices in Ukraine that are subject to certification and declaration: Classifier of medical devices NK 024:2019, (hereinafter referred to as NK 024:2019) Declaration: Class I medical devices, in-vitro diagnostic devices, group "other".
Certification:
1. Medical devices for in-vitro diagnostics intended for self-monitoring;
2. Non-sterile medical devices of classes Im, IIa, IIb, III, as well as in-vitro diagnostic devices from List B and devices intended for self-monitoring;
3. Sterile medical devices of any class, in-vitro diagnostic devices from List A, active implantable medical devices.