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.

Share this:

Other news

01.05.2021

Quality management of medical devices: we apply ISO 13485:2016 without errors

Quality management // № 4 (40), April 2021 The text of the article is available only in Ukrainian

Read more
24.09.2020

Stand-alone software as a medical device: Features of its classification and conformity assessment

Journal “Standardization, certification, quality” № 4 (122)/2020 Over the past decades, the frequency of using software in various areas of human life has increased significantly. In particular, this product has taken an important place in the medical industry. For example, as an integral part of a medical device (software incorporated in medical devices or pacemaker […]

Read more
14.10.2021

The main provisions of the principles of HACCP. The practice of developing and implementing the principles of HACCP at the enterprise.

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

Read more