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VZP Calls for the Provision of EMDN Codes

Updated: 2 days ago

If you happen to be a manufacturer, importer or distributor of medical devices (separately invoiced materials) 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 reimbursement regulations.

The assignment of EMDN to ZUM

If you are a manufacturer, assign the appropriate EMDN codes to your devices. If you are an importer or distributor, it is essential that you contact the manufacturer of the relevant devices and ask them to select and assign the relevant EMDN codes. The VZP template (link below) can be completed and sent to VZP by manufacturers, importers and distributors. However, it is always the case that the EMDN code must be assigned to the specific device by the manufacturer.


The EMDN (European MD Nomenclature) is a unified classification system for medical devices in the EU. It is a very complex, hierarchically organised and publicly available nomenclature within which each device must be assigned a code at the lowest possible level of the categorisation tree. The EMDN code will in future be linked to each UDI-DI in the EUDAMED database and is therefore mandatory for all devices placed on the market under the MDR and IVDR as well as for legacy devices.


Therefore, the VZP requires each supplier of MDs listed in the VZP Reimbursement Catalogue to send a list of EMDN codes assigned to each MD by 30 June 2025 at the latest.


For this purpose, the VZP has published a template in which the required data must be filled in. One proposal (one template) can contain up to 5,000 ZUM items. Specifically, the following is to be filled in:

  • the name of the company (claimant)

  • the name, email and title of the person authorised to deal with VZP

  • the VZP device code

  • the relevant EMDN code

    • for manufacturers: assign the code to the device according to the EMDN list (see link below)

    • for importers and distributors: contact your manufacturer and ask them to assign an EMDN code to the relevant devices

    • A link to a handy guide to EMDN nomenclature from MedTech Europe, including tips for selecting the correct EMDN code, can be found below


What to watch out for:

  • if more than one MD (multiple catalogue numbers) is listed in one ZUM entry, the corresponding EMDN code must be entered separately for each variant

  • if multiple EMDN codes are in theory applicable to a single MD, only the one that best describes the main function of the MD should be provided


The completed template must be sent in .xlsx format via the VZP data box. The subject line of the data message must state: „2.I NÁVRH NA VLOŽENÍ EMDN PRO ZUM V ÚK“.


Materials:

  • the VZP call and the template can be found here

  • the official list of EMDN codes can be found here

  • the brochure from MedTech Europe can be found here


The VZP does not now link failure to provide an EMDN code to removal from the catalogue. However, in the future, an EMDN code may be a condition for maintaining or changing reimbursement, so it is worth taking a proactive approach to the VZP request.


It is the manufacturer's responsibility to select and assign the EMDN code to the device. However, if you need help with communication to the VZP, you can contact us. We will be happy to help you.


Author: Alžběta Frýdlová

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