What To Expect In The Next Revision Of IEC 62304

The upcoming second edition of IEC 62304 introduces fundamental shifts for health software development, expanding its scope beyond medical devices and restructuring safety classification. The traditional three-tiered safety classification system is transitioning to two process rigor levels, effectively consolidating Class B and Class C requirements. This update emphasizes evaluating potential harm rather than focusing solely on injury severity, while establishing mandatory architectural planning and static code analysis across development tiers.

Navigating these regulatory changes requires early alignment of quality management procedures, particularly for teams managing standalone or artificial intelligence-enabled software. Assessing current process rigor against merged classification standards ensures long-term audit readiness ahead of international adoption. Watch the full session to explore practical strategies for updating software development procedures and maintaining compliance.