The European Business Association invites you to a meeting dedicated to the current issues of updating technical regulations in the field of medical devices, which will be held on May 8 at 10:00. The new requirements will have a significant impact on manufacturers, importers, distributors, and authorized representatives of medical devices.

Issues for discussion:

• Changes in the classification of medical devices. What products become medical devices?
• Introduction of four classes of medical devices for in vitro diagnostics
• New requirements for Technical Documentation and Quality Management Systems
• Requirements for the Authorized Representative, importer, and distributor
• Conformity assessment procedures under the new EU legislation
• Labeling of medical devices, including Unique Device Identification (UDI)

Speakers:

• Roman Mykhalko, Director of UNI-CERT LLC,
• Anna Telpiakova, First Deputy Director of UNI-CERT LLC.

Please note that prior registration is required, and only registered participants will be notified of any possible changes to the schedule.

If your company is not a member of the EBA but would like to participate in the meeting, please contact Anna.Malikova@eba.com.ua or follow the registration procedure.

See you soon!

The event was organized with the support of the International Renaissance Foundation and the European Union within the framework of the joint initiative “European Renaissance of Ukraine.” The material represents the position of the authors and does not necessarily reflect the position of the International Renaissance Foundation and the European Union.