Marek Nerandžič

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.

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.