EUDAMED Timeline: Mandatory Use by Q4 2025
The European Union in recognizing the pivotal role played by the EUDAMED system in safeguarding patient safety and efficiency of medical devices within the market, are expected to usher in amendments to Regulations (EU) 2017/745 and (EU) 2017/746 expediting the use of EUDAMED on a modular basis starting with Device Registration and Notified Bodies & Certificates modules in late 2025.
Central to the effective implementation of the Medical Device Regulation and IVD Regulation, The Commission proposed changes to expedite its mandatory use of EUDAMED on January 23, 2024. Unlike the current provisions, which mandate its use only when all modules are fully functional, the revised approach proposes flexibility by allowing a modular rollout starting with the Device Registration and Notified Bodies & Certificates modules. The Commission advocates for the gradual implementation of EUDAMED modules as soon as these modules are audited and declared functional. This strategic shift paves the way for the mandatory registration of devices under MDR commencing as early as 2025. We note also that IVDR transitional timelines for legacy devices have been extended as part of this proposal. The Commission’s rationale for this change is based on their concern to ensure continuous supply of IVD devices.
Impact to Manufacturers
Device Manufactures and System & Procedure Pack (SPP) Producers should treat Q4 2025 as a likely new deadline for mandatory compliance for device registration in EUDAMED based on the Commission’s phased modular rollout proposal.
Innovit, being a proud contributor and member of MedTech Europe, supported their joint open letter outlining 4 critical preconditions for mandatory use of the EUDAMED UDI Module:
- The modules are fully developed, tested, audited and ready for practical implementation.
- EUDAMED enables the most efficient use of Notified Body and Manufacturer resources.
- Realistic and reliable implementation and transition timelines are provided.
- Redundancy in National Databases is eliminated.
We are hopeful that the Commission will continue to make progress against these preconditions prior to the Q4 2025 deadline. With this said, for the suppliers that put EUDAMED master data developments on hold, or for the manufacturers that are yet to begin analyzing the EUDAMED requirements, you should begin to reconvene your steering committees and organize your internal stakeholders responsible for providing or approving your device submissions to EUDAMED.
How Innovit Can Help You
Innovit is a reliable and valuable ally for companies navigating the complexities of EUDAMED data compliance and global device registration tracking. We continuously stay on top of the changing UDI landscape through our partnerships with medical device companies and MedTech industry associations. With our extensive experience in Healthcare and Life Science, focusing on master data management and UDI compliance, we bring insights that are not yet in the public arena, helping our customers stay ahead of the UDI regulatory curve.
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