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

29.08.2022

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.

Other news

09.01.2023

Public health: more time to certify medical devices to mitigate risks of shortages

On January 6, 2023 the European Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines depend on the medical devices’ risk class and will […]

Read more
22.08.2024

Registration of medical devices

The program of the event is available only on Ukrainian

Read more
14.09.2023

Recognition of EU certificates for medical devices: prospects and opportunities

Quality management // № 09 / 2023, September The procedure for assessing the conformity of medical devices through the recognition of EU certificates is one of the possible ways to introduce medical devices into circulation in conditions of war, pandemic or other force majeure circumstances that prevent conformity assessment bodies from conducting regular assessment procedures […]

Read more