{"id":17502,"date":"2023-08-28T09:14:11","date_gmt":"2023-08-28T07:14:11","guid":{"rendered":"https:\/\/eudamed.com\/?p=17502"},"modified":"2024-12-05T11:52:11","modified_gmt":"2024-12-05T10:52:11","slug":"eudamed-status","status":"publish","type":"post","link":"https:\/\/eudamed.com\/index.php\/2023\/08\/28\/eudamed-status\/","title":{"rendered":"EUDAMED Status?"},"content":{"rendered":"\r\n

What is EUDAMED?<\/h2>\r\n\r\n\r\n\r\n

EUDAMED is the European Commission\u2019s Medical Device and In Vitro Device Database. This is core to the\u00a0MDR<\/a>\u00a0and\u00a0IVDR<\/a>\u00a0regulations.<\/p>\r\n\r\n\r\n\r\n

What is the current EUDAMED status? (Updated Dec 2024)<\/h2>\r\n\r\n\r\n\r\n

EUDAMED has three live modules, Actors, Devices, and Certificates & Notified bodies. We are still waiting for the final three modules, later, the new EUDAMED timelines are here with EUDAMED being designated as full function in Q4 2025. This is a partial deployment of Actors, Devices, Certificates, and\u00a0 Market surveillance, with Vigilance available in July 2026 and Clinical Investigations not until 2027.<\/p>\r\n\r\n\r\n\r\n

The current live modules Devices, Certificates, and Actors are all working well. There is no reason not to get your company’s Single Registration Number (SRN). And with the devices module working well the submission of your DIs can and should proceed ASAP. If you submit your data now, in 2025 you and your team will have a lot less EUDAMED-related stress. EirMed https:\/\/eudamed.com<\/a>\u00a0can provide you with proven EUDAMED submission software and we can also manage your entire EUDAMED project. We offer a complete EUDAMED service from collating your data to final EUDAMED submissions and procedures for future EUDAMED management.<\/p>\r\n

\"EUDAMED\"<\/p>\r\n\r\n\r\n\r\n

Why Submit to EUDAMED ASAP?<\/h2>\r\n\r\n\r\n\r\n
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  1. The UDI Device module requirements are stable, there will be no changes to the requirements before the 2027 review.<\/li>\r\n\r\n\r\n\r\n
  2. We expect a tsunami of company’s UDI submissions in Q1\/Q2 2025. This may impact the level of support available to companies. With EUDAMED fully functional in Q4 2025 the deadlines are getting dangerously close. Do not forget all serious vigilance reporting will be mandatory in EUDAMED after it is fully functional.<\/li>\r\n\r\n\r\n\r\n
  3. Some Competent Authorities already require companies to enter their regulation devices in EUDAMED as part of their national device registration process.<\/li>\r\n<\/ol>\r\n\r\n\r\n\r\n