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.

An amendment to the Prices Act came into force, which fundamentally changes the procedural rules of the price regulation of MDs.