On August 31, the 12th Ukrainian Forum of Medical Devices Market Operators was held, which provided manufacturers, suppliers, distributors, and importers of medical devices with a platform for solving all urgent issues, discussions, recommendations, and sharing valuable experience in doing business during martial law.

The Ukrainian Scientific Institute of Certification traditionally sponsored this event. In addition, Mykola Matlayev, the chief auditor of the conformity assessment department, made a report on the topic “New requirements of MDR and ISO 13485 for the distributor of a foreign manufacturer”, which highlighted the issues related to the requirements of the MDR for distributors of medical products and the need to implement the QMS according to ISO requirements 13485 for distributors and authorized representatives of foreign manufacturers in Ukraine.

After the end of the session, a lively discussion took place, which discussed possible practical solutions for market participants to overcome the difficulties associated with changes in European regulatory legislation.