The EU has adopted Regulation (EU) 2023/2854 on data (Data Act). The aim is to create a uniform framework for fair and secure sharing of data from connected devices and digital services, strengthen user rights, and promote innovation across sectors. The Data Act will also have a significant impact on healthcare, particularly on medical devices that collect and transmit data on their use or on the patient's health status.

The European Commission has launched a review of the European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The aim is to reduce the administrative and financial burden, which in practice mainly affects smaller manufacturers and hinders innovation. The Czech Republic actively participated in the consultations and sent its comments and suggestions for improvement to Brussels.

EUDAPORT is a new complex service that offers manufacturers of medical devices and IVDs a fast and user-friendly way to prepare, check and bulk upload data to the EUDAMED database as part of mandatory registrations.

Every now and then, a new term pops up in Czech healthcare, which then occupies a significant amount of space in public professional discussions, without us being able to tangibly see its practical application in the system. This category certainly includes the areas of digitization, HTA, and AI. However, the Ministry of Health has decided to take a different approach to the issue of telemedicine health services.

From 1 January 2026, medical devices will have to be prescribed electronically. The traditional paper form will remain valid only in a very limited number of exceptional cases. Prescribers, dispensers, and their IT system providers now have six months to ensure proper implementation.

Ethanol – an ubiquitous alcohol used safely for decades – is a key ingredient in many healthcare, hygiene, and cosmetic products, valued for its proven properties. It has well-documented antimicrobial effects and works as an effective solvent for a broad range of active substances. In biocidal products, ethanol is also a crucial active ingredient with a long use history.

The Chamber of Deputies has successfully passed an important amendment to the Public Health Insurance Act, introducing a wide range of changes across various areas. Some of the proposals sparked controversy, with several ultimately being rejected by lawmakers.

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.