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DTSTART;TZID=Europe/Brussels:20260528T000000
DTEND;TZID=Europe/Brussels:20260528T235959
DTSTAMP:20260418T000406
CREATED:20260127T081040Z
LAST-MODIFIED:20260127T081211Z
UID:10000036-1779926400-1780012799@www.obelis.net
SUMMARY:EUDAMED Registration Becomes Mandatory – May 2026
DESCRIPTION:Regulatory Alert | EUDAMED becomes mandatory\n\n\n\nCommission Decision (EU) 2025/2371 confirms the full functionality of the first four EUDAMED modules. As a result\, economic operators must comply with mandatory registration requirements. \n\n\n\nMandatory modules from 28 May 2026: \n\n\n\n✅Market Surveillance \n\n\n\n✅Actors: registration of manufacturers\, authorised representatives\, importers \n\n\n\n✅UDI / Devices: device registration (excluding custom-made devices) \n\n\n\n✅Notified Bodies & Certificates \n\n\n\nA six-month transition period (until November 27\, 2026) applies only to devices placed on the market before May 28\, 2026. Devices placed on the market after this date must be registered before market access. \n\n\n\nObelis supports manufacturers at every step of EUDAMED compliance!
URL:https://www.obelis.net/events/eudamed-registration-becomes-mandatory-may-2026/
CATEGORIES:Deadlines
ATTACH;FMTTYPE=image/jpeg:https://www.obelis.net/wp-content/uploads/2026/01/341.jpg
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