The EUDAMED deadline 2026 is approaching faster than many think
By no later than November 28, 2026 , manufacturers must register the following products in EUDAMED :
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Legacy Devices
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MDR and IVDR products with CE marking before May 28, 2026
What is often perceived as a formal compliance deadline is in reality one of the biggest structured regulatory data challenges of recent years.
The extent of the EUDAMED registration is often underestimated
There are currently more than 500,000 medical devices and IVDs on the EU market.
For many companies, the exact number of affected product variants is not fully transparent.At the same time, EUDAMED requires:
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Structured and consistent master data
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Variant-specific transparency
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MDR-/IVDR-compliant regulatory attributes
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Complete and traceable documentation
With the end of the transition period, the risks increase:
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Possible bottlenecks in accessing EUDAMED
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Limited internal regulatory resources
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Fragmented data landscapes across PLM, ERP, Excel and document systems
The challenge is not theoretical - it is operational and structural.
Timeline of EUDAMED Requirements
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May 2026
Deadline for CE marking of MDR/IVDR products in the context of transitional registration
Preparation Phase
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November 2026
Mandatory registration in EUDAMED
Important Insight:
2026 is not the year when preparation begins.
2026 is the year when systems must be stable, validated, and scalable.
EUDAMED is not a registration project
From our experience in regulatory and PLM transformation projects, it applies:
EUDAMED is not an upload task. It is a data architecture challenge.
Late-started registration initiatives often reveal:
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Inconsistent master product data
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Lack of linkage between Regulatory and Engineering
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Manual reconciliations between Quality, Regulatory and Operations
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Lack of digital end-to-end traceability
Even powerful bulk upload or M2M solutions cannot compensate for fragmented source systems.
The Strategic Lever: Integration of PLM and RIM
Sustainable EUDAMED-Readiness requires:
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Harmonized regulatory processes
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Integrated PLM and RIM environments
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Structured product data models
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Digital traceability throughout the entire lifecycle
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Sustainable data governance structures
If Regulatory Information Management is directly embedded into the PLM backbone, the following results:
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A central single source of truth for product and regulatory data
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Submission-ready data sets
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Improved auditability
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Reduced compliance risk
Scalability for future regulatory requirements
EUDAMED thus becomes the natural output of a networked system - not a last-minute compliance project.
How mediatec supports EUDAMED-capable architectures
mediatec.net supports medical technology manufacturers in building connected regulatory ecosystems - not isolated compliance projects.
Our approach combines:
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PLM-centered data architecture
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Integrated Regulatory Information Management (RIM)
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Variant-specific product structuring
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Governance frameworks for sustainable data quality
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AI-supported assistance of regulatory processes
By embedding regulatory information directly into the digital product backbone - for example in Aras PLM environments - we transform compliance from a reactive obligation to a strategic capability.
Future viability begins with networked data
The EUDAMED deadline 2026 is set.
The crucial question is not whether data must be registered - but whether systems are capable of providing structured, consistent, and submission-ready information without operational disruptions.
You don't become EUDAMED-ready in November 2026.
You become EUDAMED-ready through networked PLM and RIM architecture - today.
Contact
If you want to systematically assess your current EUDAMED readiness, mediatec supports with architecture and process assessment workshops for MDR and IVDR environments.