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    Trend Reporting (MDR/MIR)

    Obligation to report statistically significant increases in expected non-serious incidents.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    EU MDR Article 88 requires trend reporting when expected adverse events show a clinically significant increase. Sponsors define the trend signals, thresholds, and analysis frequency in the PMS plan.

    What this means in practice

    Trend reporting closes the gap between routine vigilance (per-event) and PMS evaluation (periodic) - and is one of the more difficult areas for PRRCs to operationalize.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1European Commission·1MDCG·1
    1. 1
      MDR Article 88
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      EUDAMED Public Site
      Verified
      European Commissionec.europa.eu
    3. 3
      MDCG Vigilance Guidance
      Verified
      MDCGhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.