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.

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.