Hardware Podcasts

#339: UDI and the State of EUDAMED

Global Medical Device Podcast · 12 Oct 2023 · 1h 02m · Episode 339

What this episode covers

Richard Houlihan, founder of EirMed and former head of the European Commission's IT team for EUDAMED, explains the history, delays, and technical complexities of the European Database for Medical Devices. He details the shift from legacy systems to the new UDI Device Module, highlighting the massive data collation efforts required for compliance with the Medical Device Regulation (MDR). Houlihan warns that while the database is delayed until Q2 2025, companies must start preparing now to avoid legal sales bans and vigilance reporting failures.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
EirMed, Greenlight Guru, FDA, KPMG
Also
EUDAMED, GUDID, MDR, IVDR

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