We have developed the EUDAPORT tool, which combines user-friendly and time-efficient data entry for medical devices with formal (and, if desired, content-based) validation in accordance with the rules and data structure of the EUDAMED database. We are continuously responding to current market needs and, in collaboration with GS1 Czech Republic, are pleased to announce an important new feature – the integration of the EUDAPORT tool with GS1 GDSN, within the Synfony catalogue.

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.

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.