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
The program of the event is available only on Ukrainian or Russian
Read moreThe program of the event is available only on Ukrainian or Russian
Read moreSince the Technical Regulations entered into force, discussions on the possibility of simplifying conformity assessment procedures, especially for medical devices of high-risk classes have been underway. Recently, we have had positive and relevant news regarding the recognition procedures in Ukraine for certificates of conformity issued by some notified bodies, accredited in the EU. To put […]
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