Yesterday, the AEFI course “EUDAMED 2026: How to Comply with the New Obligations for Manufacturers of Medical Devices and In Vitro Diagnostic Medical Devices” took place.
Following the European Commission’s announcement at the end of 2025 regarding the mandatory compliance with certain EUDAMED modules, this course, coordinated by Fran Rodríguez, featured Asphalion expert Diego Sanoja, who reviewed the key aspects for correct data submission to EUDAMED, the information that must be provided, current deadlines, as well as methodologies and recommendations for keeping registrations up to date.
In turn, Manel Martinez, Head of Standards at AECOC/GS1 Spain, explained the UDI coding system to ensure compliance with the MDR and IVDR regulations, the GS1 standards as the entity designated by the European Commission for issuing these codes, and best practices for their assignment, representation, and maintenance.
To conclude, attendees had the opportunity to interact directly with the speakers, addressing questions and further exploring the topics presented during the course.
We would like to thank AEFI for providing the framework to deliver such highly relevant training activities for the MedTech industry.
Need help with EUDAMED, MDR, or IVDR compliance? Contact us—our experts are here to help: [email protected]
