EUDAMED Mandatory Rollout Begins in May 2026: Multilingual Medical Device Registration Under Regulation (EU) 2024/1860
Following the gradual rollout framework established by Regulation (EU) 2024/1860 and the European Commission’s November 2025 Official Journal notice, the first four EUDAMED modules—Actor, UDI/Device, Notified Bodies/Certificates, and Market Surveillance—become mandatory on May 28, 2026.
May 28, 2026: Gradual Mandatory Enforcement of EUDAMED Modules
Under Regulation (EU) 2024/1860 amending the MDR and IVDR to enable the gradual rollout of the European Database on Medical Devices (EUDAMED)—and following the European Commission’s formal verification notice published in the Official Journal in late November 2025—mandatory use of the first four EUDAMED modules takes effect on May 28, 2026. Medical device and IVD manufacturers must now register Actor data, UDI/Device datasets, and Notified Body certificate metadata directly inside EUDAMED rather than waiting for all six modules to complete development.
EMD-Nomenclature Alignment and Multilingual SSCP Uploads
Crucially, uploading UDI/Device records and Certificates to EUDAMED requires strict alignment with the European Medical Device Nomenclature (EMDN) and triggers mandatory public availability of the Summary of Safety and Clinical Performance (SSCP) for implantable and Class III devices (and Summary of Safety and Performance, SSP, for Class C and D IVDs). Under MDCG 2019-9 Rev.1, the SSCP—including its dedicated patient-facing lay section—must be translated into all official EU languages of the Member States where the device is marketed.
Executive Takeaways for Global Enterprises
- Key Insight: Under Regulation (EU) 2024/1860, the first four EUDAMED modules (Actor, UDI/Device, Certificates, Market Surveillance) become mandatory in May 2026.
- Key Insight: Device descriptions must map accurately to the official European Medical Device Nomenclature (EMDN).
- Key Insight: Implantable and Class III devices require multilingual SSCP translations (both clinician and patient-lay sections) uploaded to EUDAMED.
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Editorial & Copyright Attribution Note: This industry analysis has been independently synthesized and adapted by Alphatrad’s editorial team based on verified regulatory documentation and industry research originally published by European Commission – EUDAMED & Regulation (EU) 2024/1860. For the original publication and primary documentation, please consult:
Source: https://health.ec.europa.eu/medical-devices-eudamed/overview_en
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