IEC 62304 Revision in Progress: Key Updates
- QV Solutions
- Mar 19
- 2 min read
A new revision of IEC 62304, the cornerstone standard for medical device software lifecycle processes, is currently under development. According to the BSI website, the draft is complete and open for public comment until February 12, 2025. The comment resolution, approval, and publication process is anticipated to be completed by August 2026.
This revision introduces significant changes to the standard. A quick review of the draft highlights several key updates:
1. Expanded Scope: The field of application has been broadened to encompass a wider range of software, including:
-Software as part of a medical device (e.g., infusion pump)
-Software as part of specific health hardware (e.g., software in a diagnostic wristband)
-Software as a medical device (SaMD) (e.g., diagnostic image analysis)
-Software-only products for managing, maintaining, improving health, or delivering care (e.g., clinical software as a service)
-Health software with AI/ML capabilities
2. Software Process Rigor Levels: The traditional three software safety classes (A, B, and C) have been replaced with two software process rigor levels:
-Level 1: Applies to software where no harm or only negligible harm is possible. This level effectively replaces the former safety class A.
-Level 2: Applies to software where harm is possible. This level effectively replaces the former safety classes B and C.
3. Dedicated AI/ML Software Development Process: The software development process now includes a dedicated section for Artificial Intelligence (AI). This new clause addresses AI-based devices and covers a range of technologies, including:
AI (basic decision trees, logic gates AND/OR)
Machine Learning (ML)
Deep Learning (DL) (explicitly noted as a subset of ML)
Reinforcement Learning (RL)
Large Language Models (LLMs), with the intention of encompassing Generative or General AI models.
There are multiple additional changes. Thank you Christian Kaestner for sharing the draft.
Comments