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.

Since 2017, when the Constitutional Court issued a groundbreaking ruling overturning previous regulations on reimbursable medical devices prescribed by voucher, experts have been discussing the urgent need for a new legislative framework governing the inclusion of separately billed material (ZUM) in public health insurance reimbursements. In the interim, VZP has developed a relatively transparent methodology designed to temporarily bridge the gaps in the inadequate legal fram

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.