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

14.06.2024

OBL-OEM CONFORMITY ASSESSMENT OF MEDICAL DEVICES Analysis of technical documentation, audits, supervisions and recertification

Text is available only in Ukrainian

Read more
13.03.2023

Requirements and rules for placing medical devices on the market, including in vitro, for legal implementation

PROGRAM The importance of quality control of medical products for business Classification of medical products SI units Marking. Meaning of symbols. New symbols of 2022. Instructions for medical products Accompanying documents. Certificates of conformity. Declaration of conformity. Methods of checking the validity of certificates

Read more
14.07.2023

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