IEC 82304-1 complements IEC 62304 by addressing health software products as standalone products, with requirements covering identification, requirements, validation, accompanying information, and post-market activities. IEC 82304-1:2016 applies to health software products intended to run on general computing platforms without dedicated hardware, including both medical device software and wellness software. It relies on IEC 62304 for the software lifecycle but adds requirements for the whole product, such as product requirements, product validation and accompanying documents. It is commonly used for health apps and is related to the ISO/TS 82304-2 health app quality label.

Why it matters

Particularly relevant for SaMD distributed independently of any specific hardware (mobile apps, web platforms, cloud services).

Common pitfalls

•A common pitfall is assuming compliance with IEC 62304 alone is sufficient for standalone health software, neglecting the broader lifecycle requirements introduced by IEC 82304-1.
•Manufacturers often err by not adequately defining the intended use and user profiles for their health software, leading to validation shortcomings.
•Another mistake is overlooking the critical post-market surveillance activities specifically for standalone software, which differ from hardware-integrated software.
•Underestimating the cybersecurity risks inherent in standalone health software, especially for products connected to networks or cloud services, is a significant pitfall.

Sources

IEC 82304-1 · IEC
FDA Recognized Consensus Standards · FDA
ISO Standards Catalogue - Health · ISO

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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.

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