As part of its long-standing efforts to join the EU, Ukraine has established an authorisation system for medical devices and in-vitro diagnostics based on the European model. This also includes the designation of local conformity assessment bodies and the fact that the authorities have a supervising role only.

We cooperate with the Ukrainian organisations Improve Medical LLC and UNI-CERT LLC. manufacturers. If our customers operate their product approval with one of these bodies, they can benefit from our certification in accordance with EU directives and regulations by having it recognised. The co-operation procedure reduces redundant auditing or the submission of extensive documents on the QM system or technical documentation. This generally results in significant time and cost savings for manufacturers.

The procedure essentially involves a declaration of consent that mdc may transmit existing reports and other information on the content of the relevant conformity assessment procedure to the cooperating Ukrainian body.