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. Trend reports cover incidents that are not serious incidents and expected undesirable side effects that could significantly affect the benefit-risk analysis, when their frequency or severity increases significantly. Manufacturers must define how they detect a statistically significant increase, the observation period and thresholds, in the PMS plan. Reports are submitted through EUDAMED using the manufacturer trend report form.

Why it matters

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.

Common pitfalls

•A common pitfall is failing to establish clear, objective trend signals and thresholds in the PMS plan, leading to subjective interpretations and inconsistent reporting.
•Manufacturers often struggle with integrating trend reporting data effectively from various sources, such as complaint handling, vigilance, and clinical follow-up activities.
•One mistake is not adequately documenting the rationale for chosen trend thresholds, which can lead to difficulties during regulatory audits.
•Another pitfall is delaying the aggregation and analysis of post-market data, which can result in missing critical trends until it is too late to act proactively.
•Failing to allocate sufficient resources, including personnel and appropriate software tools, for continuous trend analysis is a frequent oversight.

Sources

MDR Article 88 · EUR-Lex
EUDAMED Public Site · European Commission
MDCG Vigilance Guidance · MDCG

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