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.

Recent reports of the repeated use of single-use medical devices in some Czech hospitals have sparked a wave of debate and understandable concerns about patient safety. A closer look at the situation, however, reveals that this is not a matter of isolated failures, but rather a much broader phenomenon. This stems directly from economic pressure on healthcare facilities and likely occurs to varying degrees across the entire sector.

In December 2025, the European Commission presented a proposal for a revision of the Medical Devices Regulation (MDR). Its aim is to reduce the administrative burden, strengthen the proportionality of regulatory requirements, and maintain high level of patient protection. The proposed changes significantly affect medical device manufacturers in particular, covering their products entire life cycle. However, it is yet still only a legislative proposal that may change.

The European Commission has presented a large package of measures aimed at strengthening innovation, competitiveness, and resilience in European healthcare. The proposal is based on three pillars – the Biotech Act, the revision of the MDR and IVDR, and the new Safe Hearts Plan – and aims to simplify regulation, reduce administrative burden, and accelerate the transfer of innovation into clinical practice while maintaining a high level of patients' protection.

A major event shook the entire world of medical devices at the end of November this year. After almost five and a half years of postponements and delays, on November 27, the European Commission published a Decision in the Official Journal of the EU (OJEU) announcing the full functionality of the first four modules of the EUDAMED database. This notification represents a fundamental and absolutely crucial prerequisite for the mandatory use of the EUDAMED database.

Following extensive postponements, the European Commission has at last issued a Decision on the notice regarding the full functionality of first four EUDAMED database modules in the Official Journal of the EU (OJEU) on November 27, 2025.

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.

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.