EU Confirms EUDAMED Functionality and 2026 Deadline

The European Commission has officially confirmed that several key electronic systems within the European Database on Medical Devices (EUDAMED) are now fully functional and meet the functional specifications required under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This confirmation was published on 27 November 2025 through Commission Implementing Decision (EU) 2025/2371, marking a major milestone in the progressive rollout of the EU’s digital regulatory framework for medical devices and IVDs. 

EUDAMED Modules Declared Fully Functional 

Following an independent audit conducted in accordance with Article 34(2) MDR, the European Commission has validated four EUDAMED electronic systems as functional: 

• Actors Registration 

• UDI Database & Device Registration 

• Notified Bodies & Certificates 

• Market Surveillance 

These systems have been verified to meet the applicable functional specifications and will now proceed into their mandatory-use phase as outlined in the MDR and IVDR. 

EUDAMED Mandatory Use Timeline and 2026 Deadline 

With the publication of the Implementing Decision, the formal transition toward mandatory EUDAMED usage has commenced. The regulatory timelines are as follows: 

Key Dates 

• 27 November 2025 – Publication of Commission Implementing Decision (EU) 2025/2371 confirming system functionality 

• 28 May 2026 – Mandatory use of the four validated EUDAMED modules begins, following the six-month transition period 

• Q2 2027 – Mandatory use of the Vigilance module anticipated, subject to successful audit completion and the publication of a separate notice 

The European Commission has also made onboarding and training resources available to support stakeholders as they prepare for the mandatory-use requirements. 

How MedEnvoy Supports Manufacturers

As the EU advances toward full digital regulatory enforcement, MedEnvoy supports manufacturers, importers, and other economic operators in meeting their MDR/IVDR and EUDAMED obligations and with the upcoming EUDAMED 2026 Deadline. Our support includes: 

• Guidance on EUDAMED Requirements 

We provide clear and structured support to help organizations understand and fulfil their EUDAMED responsibilities, including actor registration, device registration, UDI obligations, and required data submissions. 

• UDI and Device Registration Support 

In line with Commission Implementing Decision (EU) 2025/2371, the MedEnvoy EUDAMED Registration Management Service assists manufacturers in preparing, validating, and submitting compliant UDI and device data. Support includes: 

• Confirming compliance with MDR/IVDR device attribute requirements. 

• Performing accuracy and consistency validations based on EUDAMED validation rules. 

• Compiling full datasets required for EUDAMED device registration. 

• Perform device registration from our GloRIAS platform, which also supports other registration databases. 

• Monitoring Regulatory Developments 

We continuously track updates from the European Commission, the MDCG, and national authorities to ensure stakeholders remain informed of evolving requirements and implementation timelines. 

We encourage you to contact our team for tailored support. Contact us so we can assist you.