--- title: "Post-Production Information (Risk)… | MedTech Terms" description: "ISO 14971 requirement to feed real-world post-market data back into the risk management process. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Post-Production Information (Risk) [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system)[Clinical Evidence](/ecosystems/clinical-evidence) # Post-Production Information (Risk) ISO 14971 requirement to feed real-world post-market data back into the risk management process. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Manufacturers must establish a system to collect and review production and post-production information - complaints, service data, MDRs, literature - and update risk estimates and controls when needed. What the regulation says Under EU [MDR](/terms/mdr-reporting) 2017/745, manufacturers are obligated to plan, establish, document, والر implement a [post-market surveillance](/terms/post-market-surveillance) (PMS) system as detailed in Article 83 and Annex III, which includes gathering post-production information. Similarly, the FDA’s [Quality System Regulation](/terms/qsr), specifically 21 CFR 820.30 ( [Design Controls](/terms/design-controls)), implicitly requires the review of post-production information to ensure design outputs meet user needs and intended uses. [ISO 14971](/terms/iso-14971):2019, Clause 10 (Post-production information), explicitly mandates the systematic collection and review of information from production and post-production phases to monitor the effectiveness of risk control measures and to identify new hazards or hazardous situations. ## What this means in practice PPI is the loop that connects [PMS](/terms/post-market-surveillance)/vigilance to the risk file; weak PPI handling is a common audit finding under [MDR](/terms/mdr-reporting). ## Examples - A manufacturer analyzes complaint data revealing a recurrent issue with a device’s user interface, prompting a re-evaluation of usability risks and potential design changes. - Service reports for an imaging device indicate a pattern of component failures after a specific number of operating hours, leading to an update in the device’s maintenance schedule and risk analysis for component longevity. - Clinical literature review uncovers a new, previously unconsidered adverse event associated with a similar type of MedTech device, prompting the manufacturer to reassess its device’s risk profile and potentially revise its labeling. Common pitfalls - • Failing to integrate post-production information review into the overall risk management process can lead to overlooked risks. - • Treating post-production information collection as a passive activity, rather than an active and systematic process, is a common pitfall. - • Not adequately documenting the analysis and decisions made based on post-production information can result in deficiencies during audits. - • Delaying the update of risk management files and clinical evaluations (e.g., CERs, PMCF plans) with new post-production insights is a frequent non-compliance point. - • Confusing post-production information collection with mere complaint handling, neglecting other crucial data sources, is a narrow interpretation of the requirement. ## Frequently asked questions What types of information constitute Post-Production Information (Risk)? This includes, but is not limited to, complaints, vigilance reports, service records, maintenance logs, user feedback, scientific literature, clinical experience, and data from [Post-Market Clinical Follow-up](/terms/pmcf) studies. How often should Post-Production Information be reviewed? What is the primary goal of collecting and reviewing Post-Production Information? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Standards ISO 14971 International standard for the application of risk management to medical devices. ](/terms/iso-14971) ### More in Quality & Risk · Same category [ Quality & Risk Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. ](/terms/biocompatibility)[ Quality & Risk CAPA Effectiveness Check Verification step confirming a corrective or preventive action actually fixed the problem. ](/terms/capa-effectiveness)[ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Quality System](/ecosystems/quality-system) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 AAMI· 1 1. [1 ISO 14971 Cl. 10 Verified ISO · iso.org ](https://www.iso.org/standard/72704.html) 2. [2 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) 3. [3 AAMI - Quality Systems Resources Verified AAMI · aami.org ](https://www.aami.org/standards) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Tying cybersecurity into your QMS? We help align cybersecurity activities with ISO 13485 design controls and ISO 14971 risk management. [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 Quality & Risk Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=post-production-info) Learn in 60 seconds Card Lesson Quiz ISO 14971 requirement to feed real-world post-market data back into the risk management process. - · PPI is the loop that connects PMS/vigilance to the risk file; weak PPI handling is a common audit finding under MDR. Remember this Watch out: Failing to integrate post-production information review into the overall risk management process can lead to overlooked risks. Related terms - [ISO 14971 ](/terms/iso-14971) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Risk Management File(RMF) ](/terms/risk-management-file) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [Threat Modeling ](/terms/threat-modeling) - [Complaint Handling ](/terms/complaint-handling) [All Quality & Risk terms](/terms?cat=Quality%20%26%20Risk) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.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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