Hello everyone,
With the May 28, 2026 deadline for the first four mandatory EUDAMED modules rapidly approaching, our regulatory team is feeling the time crunch. As confirmed by Commission Decision (EU) 2025/2371 published on November 27, 2025, we are now in the final stretch of the 6-month transition period for the Actor, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance modules.
While we have our Single Registration Number (SRN) sorted for the Actor module, the UDI/Devices module is proving to be a massive headache for our legacy portfolio. We know that for legacy devices already on the market before May 28, 2026, the final registration deadline is November 27, 2026. However, ensuring that our internal data governance perfectly aligns with EUDAMED's required Basic UDI-DI attributes is causing some internal friction.
We actually had to bring in some external medical device MDR consultants to assist with a complete attribute assessment and sandbox testing to prevent rejection loops. They flagged a few gaps in our technical documentation regarding EMDN code granularity that we hadn't noticed during static reviews.
I'm curious how others in this subforum are managing the final push:
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Are you handling the EUDAMED M2M (Machine-to-Machine) XML data uploads entirely in-house, or are you relying on third-party software connectors?
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How are you prioritizing your legacy device uploads leading up to the November 27, 2026 cutoff?
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Has anyone started updating their QMS to reflect the newly updated harmonised standards from Commission Implementing Decision (EU) 2026/193 (published on January 30, 2026)?
Would love to hear how you are all navigating these Q2/Q4 2026 bottlenecks!