A Documentation Architecture Framework for Class I, II, and III Medical Device Programs
Medical device documentation failures are regulatory failures — they result in warning letters, import alerts, CE marking withdrawal, and product recalls. The documentation architecture decisions made during device development determine whether a program can survive FDA inspection, notified body audit, and post-market surveillance. This technical standard provides a prescriptive documentation architecture framework grounded in regulatory requirements and practitioner experience across Class I, II, and III medical device programs.
This technical standard establishes documentation architecture requirements for medical device programs subject to FDA 21 CFR Part 820, EU Medical Device Regulation 2017/745, and ISO 13485:2016 Quality Management System requirements. The standard provides a unified documentation framework addressing Design History Files, Technical Files, Clinical Evaluation Reports, Risk Management Files, and Instructions for Use across device classes.
ELDR Institute. (Q1 2026). Medical Device Documentation Standards: FDA, EU MDR, and ISO 13485. ELDR-PUB-2026-009. The ELDR Institute, ELDR Group Inc.
www.eldrinc.com/publications/medical-device-documentation-standards.html
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