The 11th Ukrainian forum of medical device market operators was held


On August 26, the 11th anniversary Ukrainian forum of medical device market operators took place, which provided manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience during martial law.

Ukrainian Scientific Institute of Certification was traditionally a partner of this event. In addition, Victoria Shevchenko, Head of conformity assessment department, and Nikolay Matlaev, Lead specialist of conformity assessment division, made a presentation on the topic of Specific features of the medical device conformity assessment in wartime with and without conformity assessment bodies involvement, which highlighted issues related to:

  • regular audits procedures and EU-certificates recognition procedures, including those with MDR
  • I class medical devices
  • devices for research use only (RUO)
  • procedure packs

After the end of the session, a lively discussion took place with the participation of representatives of state, regulatory and supervisory authorities, in which possible practical solutions were discussed to overcome the difficulties of market participants associated with maintaining the validity of certificates during a martial law and a simplified procedure for placing medical devices on the Ukrainian market.

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