Per 21 CFR 820.184, the Device History Record (DHR) contains the production records of a specific batch, lot, or unit of finished device, providing traceability of materials, process steps, and inspections. Under the QMSR, effective February 2, 2026, the DHR term was dropped and production records are covered by ISO 13485 clause 7.5.1 and the record requirements in clause 4.2.5, plus FDA's added record requirements in 820.35. The content is unchanged in practice: quantities made and released, acceptance records, labeling used, and UDI for each unit or lot. Electronic batch records must meet Part 11.

Why it matters

DHR completeness is an early indicator of manufacturing process control during inspections.

Common pitfalls

•A common pitfall is incomplete DHRs lacking crucial information such as manufacturing dates, quantities, or approval signatures, which can lead to non-conformances during audits.
•Misinterpreting "batch," "lot," or "unit" can lead to inconsistencies in DHR creation and insufficient traceability.
•Failing to include records of all rework and retesting activities in the DHR can obscure the true manufacturing history of a device.
•Not integrating DHRs with a robust electronic quality management system (eQMS) can lead to data integrity issues and inefficient record retrieval during inspections.

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.