{"id":35000,"date":"2025-12-17T15:38:47","date_gmt":"2025-12-17T14:38:47","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35000"},"modified":"2025-12-19T14:51:54","modified_gmt":"2025-12-19T13:51:54","slug":"eudamed-obligation-starts-may-28-2026-what-to-do-now","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/12\/17\/eudamed-obligation-starts-may-28-2026-what-to-do-now\/","title":{"rendered":"EUDAMED obligation starts May 28, 2026: what to do now?"},"content":{"rendered":"

Translated with AI<\/i><\/p>\n

On November 27, 2025, the European Commission announced the full functionality of four out of the six EUDAMED modules <\/strong>through Commission Implementing Decision (EU) 2025\/2371<\/strong>, published in the Official Journal of the European Union.<\/p>\n

This decision triggers a six-month transitional period<\/strong>, after which the use of the first four EUDAMED modules becomes mandatory as of 28 May 2026<\/strong>. Economic operators that have not yet made voluntary use of these modules must take action without delay.<\/p>\n

The four fully functional EUDAMED modules<\/strong><\/h3>\n

The modules declared fully functional and mandatory from 28 May 2026 are:<\/p>\n

    \n
  1. \u201cActor Registration\u201d module (ACT)
    \n<\/b>This module is intended for the mandatory registration of economic operators<\/strong>, namely manufacturers (including manufacturers of systems and procedure packs), authorised representatives, and importers, in order to obtain a <\/span>Single Registration Number (SRN)<\/strong>. <\/span>Registration in ACT is a prerequisite for all subsequent activities in EUDAMED, as required under Article 31 of Regulation (EU) 2017\/745 (MDR) and Article 28 of Regulation (EU) 2017\/746 (IVDR).<\/li>\n<\/ol>\n
      \n
    1. \u201cUDI\/Devices Registration\u201d module (UDI\/DEV)
      \n<\/b>This module manages UDI identifiers (UDI-DI and UDI-PI)<\/span> through a central database for MDR and IVDR devices. It collects detailed device information, including risk class, Basic UDI-DI, and data related to packaging levels and units of use.
      \n<\/span>For legacy devices regulated under the MDD or IVDD, as well as custom-made devices or devices for which no individual units are placed on the market after the module becomes mandatory, registration is required only in the context of serious incidents, field safety corrective actions (FSCAs), or vigilance activities. In such cases, EUDAMED-specific DI\/ID identifiers are used instead of standard UDI identifiers.<\/li>\n<\/ol>\n
        \n
      1. \u201cNotified Bodies and Certificates\u201d module (NB\/CRF)
        \n<\/b>This module allows Notified Bodies (NBs) to register and manage certificates issued for devices in conformity with the MDR and IVDR. It also collects Summary of Safety and Clinical Performance (SSCP) documents, which are uploaded directly by the Notified Bodies for higher-risk devices.<\/li>\n<\/ol>\n
          \n
        1. \u201cMarket Surveillance\u201d module (MSU)
          \n<\/b>Access to this module is reserved to Competent Authorities<\/strong> and supports the management of <\/span>post-market surveillance and market surveillance activities<\/strong>, including inspections and the handling of non-compliances.<\/span><\/li>\n<\/ol>\n

          Priorities for manufacturers<\/strong><\/h3>\n

          Given the short six-month transition period, manufacturers should focus on the modules under their direct responsibility, namely ACT and UDI\/DEV:<\/p>\n