EUDAMED mandatory use starts may 2026

EUDAMED mandatory use begins on May 28, 2026, and the window to act is closing. Across the industry, UDI registration numbers remain far below what is expected, data quality issues are already surfacing in the system, and many manufacturers are still unclear on what exactly needs to be in place before they can legally place a new device on the EU market.

This webinar brings together experts from osapiens and PTC to give you a clear, implementation-oriented picture of what EUDAMED compliance actually demands — from understanding the regulatory scope, to structuring your master data project, to connecting your PLM system with global UDI registries.

The session will be led by Lionel Tussau, Lead Healthcare at osapiens, who chairs the MedTech Europe EUDAMED IT Working Group and sits on the GS1 Global Healthcare Leadership Team. He brings direct, implementation-level insight into how EUDAMED works in practice, including what the system still cannot catch and where companies are most likely to run into trouble. Joining him are Jeff Holzman (osapiens) and David Wolf and Brian Veasey (PTC), practitioners who work with medical device manufacturers on exactly these challenges every day.