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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 the regulation says
Under EU MDR Article 88, manufacturers must report any statistically significant increase in the frequency or severity of incidents that are not considered serious incidents, or any statistically significant increase of anticipated undesirable side effects that could have a significant impact on the benefit-risk analysis. This includes defining trend signals, thresholds, and analysis frequency in the Post-Market Surveillance (PMS) plan, as outlined in Annex III of the EU MDR.
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.Examples
- A manufacturer of an implantable medical device reports an unusual increase in the number of patient complaints related to minor allergic reactions, even though individual reactions are not severe enough to be considered serious incidents.
- A diagnostic software manufacturer observes a statistically significant rise in false-positive rates over a three-month period, which, while not immediately harmful, could lead to incorrect medical decisions if the trend continues.
- A company producing surgical instruments identifies an increasing pattern of reported minor malfunctions during procedures, indicating a potential manufacturing defect not previously flagged as a serious issue.
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.
Frequently asked questions
The primary purpose is to identify, analyze, and report statistically significant increases in the frequency or severity of incidents, including anticipated undesirable side effects, to ensure timely protection of public health.
Related terms
Grouped by themeMore in Post-Market
· Same categoryPost-Market
5-Day Report
Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
Post-Market
Annual Report (PMA)
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
Post-Market
Customer Notification Letter
Communication to users notifying them of a safety issue, corrective action, or important product information.
Post-Market
Electronic Medical Device Reporting(eMDR)
FDA's mandatory electronic submission system for Medical Device Reports.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
EUR-Lex·1European Commission·1MDCG·1
- 1
MDR Article 88VerifiedEUR-Lexeur-lex.europa.eu
- 2
EUDAMED Public SiteVerifiedEuropean Commissionec.europa.eu
- 3
MDCG Vigilance GuidanceVerifiedMDCGhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.