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Trend reporting

Regulatory basis

Trend reporting is required under Regulation 21A of the UK MDR 2002 (as amended). It captures safety signals from accumulation of individually non-reportable events.

When a trend report is required​

Submit a trend report when a manufacturer identifies a statistically significant increase in events that individually do not meet the serious incident threshold but which, in aggregate, indicate a safety concern.

The PMS plan must pre-specify:

  • Event types tracked for trend analysis
  • Data sources
  • Statistical method
  • Baseline rates or thresholds for comparison

When the observed rate exceeds the pre-specified threshold, or when statistical analysis identifies significance, report within 30 calendar days.

Report contents​

  • Device identification
  • Event type described
  • Time period and number of events observed
  • Expected rate / baseline and data source
  • Statistical method used
  • Patient risk assessment
  • Corrective actions taken or planned

Integration with PMS and PSUR​

Trend data must be captured in the PMS report, summarised in PSURs, fed back into the risk management file if a new hazard is identified, and incorporated into the CER at the next update cycle.

Official references​

ReferenceDescription
UK MDR 2002, Regulation 21ATrend reporting obligation
MHRA: Adverse incident reporting guidanceTrend reporting section