Ukrainian Scientific Institute of Certification

Guidelines for medical devices


The Ministry of Health of Ukraine approved guidelines that are developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices.
The recommendations are not legally binding, but should be taken into account by manufacturers, authorized representatives, conformity assessment bodies and state market surveillance authorities, and other medical device market operators.
Download guidelines here