VZP is requesting that all applicants submit EMDN codes (European Medical Device Nomenclature) for all medical devices (ZÚM) listed in the VZP Reimbursement Catalogue – Medical Devices (ÚK VZP – ZP) by 30 June 2025.
This requirement follows a request from the Ministry of Health in connection with forthcoming legislation. The inclusion of EMDN codes, in accordance with Article 26 of the MDR / Article 23 of the IVDR, is essential for setting clear, transparent, and predictable rules, both within the legislative process and for the inclusion, modification, or price/reimbursement adjustment of medical devices in the ÚK VZP – ZP.
According to the current wording of the MDR / IVDR, manufacturers must assign an EMDN code to their device, which will be used for registration in the EUDAMED database and linked to the device’s Unique Device Identifier (UDI-DI).
Using the EMDN hierarchical structure, manufacturers must always assign the code at the lowest applicable level available (i.e., the most specific level of the categorisation tree).
If one ZÚM item includes multiple devices (catalogue numbers) with different EMDN codes, list each EMDN code in the corresponding “EMDN” column.
If a single device (catalogue number) has multiple intended purposes and therefore multiple potential EMDN codes, select and submit only one EMDN code.
A single submission may contain up to 5,000 ZÚM items.
The template and submission instructions are available on the VZP website.
The text of the opinion was translated using ChatGPT 4o.