How often should trend analysis be performed?

The frequency of trend analysis should be defined in the manufacturer's Post-Market Surveillance plan, based on the device's risk class, nature, and expected performance.

What kind of incidents are typically subject to trend reporting?

Trend reporting applies to incidents that are not necessarily serious incidents on an individual basis, but whose aggregation reveals a pattern indicating a potential safety concern, as well as anticipated undesirable side effects.

Who is responsible for establishing trend signals and thresholds?

The manufacturer is responsible for establishing and documenting the trend signals and thresholds in their PMS plan, in accordance with EU MDR requirements.

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Post-MarketRegulated Pathways Post-Market & Safety Global Markets

Trend Reporting (MDR/MIR)

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

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 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. 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.

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.

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Medical Device Vigilance

Reporting and management of serious incidents and field safety corrective actions.

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Post-Market Surveillance(PMS)

Activities to monitor device safety and performance after market release.

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Sources

3 sources

Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2

Link health: 3 verified· last checked 2026-06-20

EUR-Lex·1European Commission·1MDCG·1

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

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Category: Post-Market
Sources: 3
Updated: 9/19/2026

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Learn in 60 seconds

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

·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.
·Sponsors define the trend signals, thresholds, and analysis frequency in the PMS plan.

Remember this

Watch out: A common pitfall is failing to establish clear, objective trend signals and thresholds in the PMS plan, leading to subjective interpretations and inconsistent reporting.

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