Medical devices, in vitro diagnostic medical devices, active implantable medical devices

Draft Resolution of the Cabinet of Ministers of Ukraine "On Amendments to Some Resolutions of the Cabinet of Ministers of Ukraine on the Recognition of Conformity Assessment Results"; (2 page(s), in Ukrainian)

At the beginning of Russia's military aggression against Ukraine, there was a risk of complicating the work of designated bodies for conformity assessment of products with the requirements of technical regulations. The possible suspension of their work would have to a delay or blockage of imports to Ukraine of certain groups of goods that were subject to the conformity assessment procedure with the requirements of Ukrainian technical regulations with the involvement of designated conformity assessment bodies.

Therefore, on March 29, 2022 the Resolution of the Cabinet of Ministers of Ukraine No 389 "On Amendments to Some Resolutions of the Cabinet of Ministers of Ukraine on the Recognition of Conformity Assessment Results" was adopted providing for the possibility (for the duration of martial law) to recognize by a designated conformity assessment body of the results of conformity assessment of medical devices, in vitro diagnostic medical devices and active implantable medical devices carried out by foreign accredited bodies (G/TBT/N/UKR/162/Add.1 ).

To date, the majority of Ukrainian designated conformity assessment bodies have confirmed their ability to carry out conformity assessment activities and provide appropriate services to Ukrainian and foreign enterprises under martial law. Also, during the martial law period, the Ministry of Health of Ukraine has not received any applications from businesses about cases of inability of Ukrainian designated conformity assessment bodies to provide them with relevant services. Consequently, the Ukrainian infrastructure of designated conformity assessment bodies today continues to function and is able to provide business entities with the full range of services required to assess compliance with the requirements of technical regulations. In this regard, the draft Resolution of the Cabinet of Ministers of Ukraine "On Amendments to Some Resolutions of the Cabinet of Ministers of Ukraine on the Recognition of Conformity Assessment Results" was developed to exclude provisions allowing for the recognition by a designated conformity assessment body of the results of conformity assessment of medical devices, in vitro diagnostic medical devices and active implantable medical devices carried out by foreign accredited conformity assessment bodies.