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. ISO 14971:2019 clause 10 requires this system, and it ties directly to post-market surveillance under the EU MDR and complaint handling and medical device reporting in the US. Information should also cover the generally acknowledged state of the art, such as new standards, and publicly available data about similar devices. When new information changes a risk estimate, the risk management file and related controls must be updated.

Why it matters

PPI is the loop that connects PMS/vigilance to the risk file; weak PPI handling is a common audit finding under MDR.

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.

Sources

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.