Article 72 requires providers of high-risk AI systems to establish and document a post-market monitoring system proportionate to the nature of the AI technologies and the risks. The plan must actively and systematically collect, document, and analyse relevant data throughout the lifetime of the system to evaluate continuous compliance. The plan forms part of the technical documentation. For AI that is also a medical device, these activities can be folded into existing MDR or IVDR post-market surveillance systems, as long as an equivalent level of protection is achieved.

Why it matters

For MedTech, the AI Act PMM plan should be integrated with the MDR/IVDR post-market surveillance plan and the PMCF/PMPF where required. Drift metrics, calibration checks, and real-world performance thresholds belong in both plans, not as parallel programmes.

Common pitfalls

•Running two disconnected post-market programmes for the same device. Regulators expect one integrated view of performance.

Sources

Regulation (EU) 2024/1689, Article 72 · EUR-Lex
FDA - Medical Devices · FDA
European Commission - Medical Devices · European Commission

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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.