A proliferation of sources… and an accumulated risk of discrepancies
Under Regulation (EU) 2017/745 (MDR), medical device manufacturers must maintain high consistency across multiple document sets: EUDAMED, the technical file, clinical evaluation (CER), post-market clinical follow-up (PMCF), and the periodic safety update report (PSUR).
These deliverables meet distinct requirements but describe the same device: intended use, performance, benefits/risks, clinical data, and post-market surveillance. Consequently, discrepancies in terminology, indications, target population, or classification can undermine the entire documentation, particularly during notified body reviews or authority inspections.
EUDAMED as a Convergence Point (Progressive Deployment)
EUDAMED is not merely an administrative registry; it is a system of interconnected modules designed to centralize key information (actors, devices/UDI, certificates, clinical investigations, vigilance, market surveillance). Its deployment is gradual, with several modules declared functional by the end of November 2025 (enhancing authorities' ability to use the database over time).
Operational Consequence: Consistency Becomes More "Audit-Proof"
In practice, as EUDAMED becomes more operational, the consistency between declared information (e.g., UDI-DI, class, intended use, certificates) and documented information (technical file, IFU, CER, PMS/PSUR) becomes a concrete issue during audits and reviews. This is not about "automatic sanctions" triggered by the database but an increased risk of requests for clarification, observations, or even non-compliance if discrepancies are neither justified nor managed.
Frequent Discrepancies... Rarely Intentional
The observed inconsistencies are most often due to:
- partial updates (one document evolves, others follow later),
- different contributors working on different deliverables,
- asynchronous integration of clinical/regulatory changes,
- editorial legacies (historical copy-paste, synonyms, versions).
These discrepancies can persist until an external review (notified body, partner, internal audit), at which point they become costly to correct.
Why This Issue Is Escalating in 2026
The MDR requires structured, up-to-date, and consistent documentation throughout the product lifecycle (including clinical evaluation, PMS/PMCF, and, where applicable, PSUR). As EUDAMED modules become functional and widely used, the alignment between "what is written" and "what is declared" becomes more visible in interactions with third parties.
Towards More Systematic and Tool-Assisted Verification
With increasing volumes and cross-functional consistency pressures, exhaustive manual verification becomes difficult to sustain over time. Emerging needs focus primarily on:
- structured comparison of key information across documents (intended use, indications, class, claims, populations),
- identification of factual or semantic discrepancies,
- traceability of versions and corrections,
- securing simultaneous updates of multiple deliverables.
The goal is not to replace regulatory expertise but to reduce blind spots and enhance consistency.
Anticipate Rather Than Correct
In 2026, consistency between EUDAMED, CER, PSUR/PMCF, and the technical file is increasingly a marker of control. Anticipating these discrepancies (and detecting them early) secures audits, reduces iterations, and limits last-minute corrections.