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.

Other news


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

A contract on recognition of the results of the assessment of conformity with SGS Belgium NV (ID 1639)

We are pleased to inform you that the notified body SGS Belgium NV (ID 1639) has signed an arrangement for the recognition of conformity assessment results with the UNI-CERT LLC. Due to this collaboration, our clients can significantly reduce their time and financial expenses for certification of their products in Ukraine. We have already accumulated sufficient […]

Read more

Main requirements of ISO 13485:2018. Risk management according to DSTU EN ISO 14971:2015.

The program of the event is available only on Ukrainian or Russian

Read more