GTIN codes and UDI system were intended to provide complete traceability. However, a gray area prevailed and large distributors assigned their own UDI-DI codes through issuing entities. The long-awaited MDCG 2026-5 document, in conjunction with Annex VI of the MDR, finally puts an end to the speculation. Who is legally responsible for assigning UDIs, what obligations apply to repackagers under Article 16, and where do we encounter unresolved legislative pitfalls when downsizi

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