IEC 62304, the standard for the software development lifecycle for medical device software, is to be revised. According to the website of the British Standards Institution, the current draft has been completed and was open for public comment until February 12, 2025. The revised standard could be published in the course of 2026.
Based on the current draft, far-reaching changes would be included:
- The safety classification is being changed completely: classes A, B and C are being replaced by levels I and II. → Level I applies to software where no harm, or only negligible harm, is likely. This level effectively replaces the former software safety class A. → Level II applies to software where serious harm can occur. This level effectively replaces the former safety classes B and C.
- Most SaMD that currently fall under class B will fall into level II.
- The scope is being extended to cover a broader range of software. IEC 62304 now covers all health software, not just medical device software.
- No more references to ISO 13485 or ISO 14971
- An enormous expansion of the guidance in the annexes (including for AI medical device software)
The last attempt at a new version of this standard did not make it to publication. That makes it all the more interesting to see how, and whether, this draft will make it to implementation in the summer of 2026.
You can follow the progress of the publication process here: BS EN IEC 62304 ED2 BS EN 62304 Ed2. Medical device software – Software life cycle processes