--- title: "Trend Reporting (MDR/MIR), Definition | MedTech Terms" description: "Obligation to report statistically significant increases in expected non-serious incidents. Plain-English Post-Market definition for MedTech teams, with example" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/trend-reporting#term", "name": "Trend Reporting (MDR/MIR)", "description": "EU MDR Article 88 requires trend reporting when expected adverse events show a clinically significant increase. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Trend Reporting (MDR/MIR) [All terms](/terms) Post-Market [Regulated Pathways](/ecosystems/regulated-pathways)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets) # Trend Reporting (MDR/MIR) Obligation to report statistically significant increases in expected non-serious incidents. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition EU [MDR](/terms/mdr-reporting) 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](/terms/post-market-surveillance) plan. What the regulation says Under EU [MDR](/terms/mdr-reporting) 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](/terms/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](/terms/post-market-surveillance) 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 What is the primary purpose of trend reporting under EU MDR? 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. How often should trend analysis be performed? What kind of incidents are typically subject to trend reporting? Who is responsible for establishing trend signals and thresholds? ## Related terms Grouped by theme ### More in Post-Market · Same category [ Post-Market 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report)[ Post-Market Annual Report (PMA) Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. ](/terms/annual-report-pma)[ Post-Market Customer Notification Letter Communication to users notifying them of a safety issue, corrective action, or important product information. ](/terms/customer-notification)[ Post-Market Electronic Medical Device Reporting(eMDR) FDA's mandatory electronic submission system for Medical Device Reports. ](/terms/emdr) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 European Commission· 1 MDCG· 1 1. [1 MDR Article 88 Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 2. [2 EUDAMED Public Site Verified European Commission · ec.europa.eu ](https://ec.europa.eu/tools/eudamed/) 3. [3 MDCG Vigilance Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Post-Market Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=trend-reporting) Learn in 60 seconds Card Lesson Quiz 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. You may also need Auto-suggested from Post-Market and shared keywords. - [IDE Annual Progress Report ](/terms/ide-annual-report) - [Post-Market Surveillance Plan ](/terms/pms-plan) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Unanticipated Adverse Device Effect(UADE) ](/terms/uade) - [5-Day Report ](/terms/five-day-report) - [Annual Report (PMA) ](/terms/annual-report-pma) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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