Alžběta Frýdlová

If you are a manufacturer, importer or distributor of medical devices (ZUM) included in the VZP Reimbursement Catalogue, you are now obliged to provide the VZP with EMDN codes for these MDs by 30 June 2025. The requirement for each manufacturer to assign an EMDN code to all its devices is based on European regulations, specifically Article 26 of the MDR and Article 23 of the IVDR. The VZP call also responds to the requirement of the MoH in the context of the upcoming legislation on the 

The EU is introducing new battery requirements under Regulation (EU) 2023/1542, including those used in medical devices.

Certain entities will be subject to new obligations under Regulation (EU) 2023/1115.