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.

Telemedicine and remote care are pilot projects no more. Instead they turned into themes, that could transform availability and organization of health services. Technologies evolved with the experience of providers and attempts at creating a stable framework for their usage. Nevertheless, a number of questions remain unresolved. Mainly legislative definition of telemedicine service, its funding, assessment of its health-economic benefits, and the status of software and other

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 manufact

Throughout June, not only specialized healthcare media but also the mainstream media reported in detail that Prime Minister Andrej Babiš was sending letters to Health Minister Adam Vojtěch, in which he strongly urged the implementation of numerous legislative and executive measures intended to stabilize the situation in the healthcare sector. Somewhat surprisingly, this has brought into the spotlight the legislative framework for reimbursement regulation of separately billed

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.

Implementing Regulation (EU) 2026/977 represents a fundamental procedural reform of the conformity assessment of medical devices under the MDR and IVDR. The stated goal is to harmonize differing interpretations of the regulations and the fragmented practices of notified bodies, increase transparency, and ensure market predictability—all without compromising patient safety, according to the Commission. The regulation is going to take effect on February 25, 2027.

This time, we will focus on the specifics of distribution and retail. Here, the new terms and obligations clash with strict sector-specific regulations under the MDR and IVDR; fortunately, the PPWR provides important exemptions to protect patient safety. These exemptions apply primarily to packaging that is sensitive to contact with the medical device, while group and transport packaging in the supply chain will not be exempt from the new strict environmental limits.

The rules governing the advertising of MDs and IVDs are set to undergo a significant overhaul. Although the originally proposed amendment to the Advertising Regulation Act was not debated during the previous legislative session, it is now returning to the Chamber of Deputies as Bill No. 153. In addition, the proposal also addresses the necessary implementation of European legislation on infant formula. If the legislative process proceeds as usual, the new rules will take effe

The EU is introducing changes to product packaging rules. The new Regulation (EU) 2025/40 on packaging and packaging waste (PPWR) introduces stricter requirements for eco-design, recyclability, and packaging minimization. The changes will also affect the medical device sector, which is primarily governed by the MDR and IVDR. Although the PPWR generally applies to all packaging placed on the market, it introduces some exceptions for medical devices to protect patient safety an

Just a few years ago, we would have considered any remote contact between a patient and a doctor via phone or video to be telemedicine. A major turning point in the Czech healthcare system came with the mandatory use of eRecept (e-prescriptions) and, subsequently, the COVID-19 pandemic. Fear of personal contact at that time accelerated the introduction of the first reimbursed “telemedicine” service by general practitioners.