MedTech Terms
    The authoritative reference
    All terms

    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 CyberLast 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 2017/745, manufacturers are obligated to plan, establish, document, والر implement a 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, specifically 21 CFR 820.30 (Design Controls), implicitly requires the review of post-production information to ensure design outputs meet user needs and intended uses. 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/vigilance to the risk file; weak PPI handling is a common audit finding under MDR.

    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

    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 studies.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    ISO·2AAMI·1
    1. 1
      ISO 14971 Cl. 10
      Verified
      ISOiso.org
    2. 2
      ISO 13485 Standard Page
      Verified
      ISOiso.org
    3. 3
      AAMI - Quality Systems Resources
      Verified
      AAMIaami.org

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