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 legislat

Act No. 375/2022 Coll., on MDs and IVDs, stipulates that distributors and service providers listed in the Information System of Medical Devices (ISZP) must submit a change notification or confirm the accuracy of their data at least once a year—provided no changes occurred during the year. Otherwise, their activity in IZSP will be invalidated. Since ISZP has been launched in early March 2024, the first deadline to confirm data accuracy came at the beginning of last month.

Subcommittee on Drug Policy, Medical Equipment, and Medical Devices hosted a roundtable discussion on VAT rates for IVD.

March 2 is approaching, bringing with it the obligation to review and confirm their data in the ISZP system.

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