A revised version of IEC 62304 is expected to be published in August 2026.
It is currently in the final coordination phase. A transition period of 2 to 3 years can be expected before regulators require compliance with the new version.
IEC 62304 Edition 2 introduces fundamental changes:
- The three existing safety classes (A/B/C) will be replaced by two process rigor levels (I/II) .
- In addition, there are explicit requirements for AI/ML lifecycles, as well as a greater focus on cybersecurity.
- The scope is being expanded to include all health-related software and is no longer limited to medical devices
For the previous SSC A, there are few changes in the equivalent Level I. The changes are most significant for manufacturers of the previous SSC B software, as this now falls under Level II. Here, the requirements have been raised to the new Level II, which is closely modeled after the previous SSC C.
This blog post highlights the upcoming changes: