Article 11 and Annex IV require providers of high-risk AI systems to prepare and keep up to date technical documentation covering system description, design specification, monitoring and control, risk management, training and testing data (methodology, provenance, labelling, cleaning), validation and testing procedures, cybersecurity, and the post-market monitoring plan.

Why it matters

For medical devices, Annex IV elements fold into the MDR Annex II or IVDR Annex II technical documentation rather than sitting in a separate file. Data-governance evidence (Article 10) is the section most often underdeveloped in existing device technical files.

Common pitfalls

•Treating Annex IV as boilerplate. Notified bodies specifically probe training-data provenance and labelling processes.

Sources

Regulation (EU) 2024/1689, Article 11 and Annex IV · EUR-Lex
IMDRF Documents · IMDRF
RAPS Regulatory Focus · RAPS

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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.