Markéta Hrubá

Regulation (EU) 2023/1115 (EUDR) has been in force since 2023. The obligations set out in the Regulation will begin to apply on December 30 of this year. The key is to determine whether a specific product is subject to the obligations under the EUDR—that is, whether the product is among the relevant products listed in Annex I. This assessment can be the most challenging part in practice. As in many other cases, there are numerous exceptions to consider here as well.

In the previous issue of the Newsletter, we described how digitalisation is transforming healthcare, the associated security risks, and how the CSA, the CRA and the new Cybersecurity Act differ from one another. It is now appropriate to examine their practical implications: the obligations they impose on MD manufacturers, suppliers of associated digital products and healthcare providers, and the rights or claims that healthcare facilities may, in turn, assert against manufacturers and suppliers.

Securing sensitive patient data and ensuring the reliability of life-saving equipment have become absolute priorities, as any vulnerability can have fatal consequences. The EU and the Czech Republic are therefore building a strong defensive shield through legislative measures: the Cybersecurity Act (CSA), the Cybersecurity Resilience Act (CRA), and the national Cybersecurity Act (ZoKB), which complement one another, despite having different objectives.