IEC 62366-1:2015+A1:2020 — Gap Analysis
Application of Usability Engineering to Medical DevicesAbout IEC 62366-1:2015+A1:2020
IEC 62366-1:2015 (with Amendment 1:2020) specifies the application of usability engineering to medical devices. It enables manufacturers to analyse, specify, develop and evaluate the usability of devices for safety. It is referenced in EU MDR/IVDR Annex I and aligned with FDA Human Factors guidance. The process integrates with ISO 14971 risk management and is mandatory for any device intended to be used by professional or lay users.
Issuing Body
IEC Technical Committee 62A — Common aspects of electrical equipment used in medical practice
Edition
2020
Coverage
Usability engineering process to ensure safety and effectiveness of medical devices through identification and mitigation of use-related risk.
Typical Users
Medical device manufacturers — required by EU MDR/IVDR (Annex I), FDA (21 CFR 820.30), Health Canada and other regulators.
How to use this tool
1. Work through each clause. For each requirement, choose Compliant, Partial, Non-compliant, or leave as Not assessed.
2. Add notes against any requirement to record evidence, gaps, or corrective actions.
3. Click Save progress — data is stored locally in your browser, never uploaded.
4. Export the report as TXT, CSV, JSON or print to PDF for your audit file.
Note: This tool is a guided self-assessment. It does not replace a third-party audit and the authoritative version of the standard must be obtained from the issuing body.
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