The publication of a revised version of IEC 62304 was originally expected in August 2026, but has been significantly delayed: Nearly 1,500 comments were received on the 2025 Committee Draft.
So far, only the second Committee Draft has been released, which means the Final Draft will not be available until 2028 at the earliest — the IEC currently lists October 2028 as the publication date. In addition, there will likely be a transition period of 2 to 3 years before regulators require compliance with the new version. In the medium term, therefore, the classification rules will continue to apply as described in our guide.
It’s still worth taking a look at the planned changes, because 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:
IEC 62304 Edition 2 (2026): Software Process Rigor Levels, AI/ML Provisions, and What Changes for Medical Device Manufacturers | MedDeviceGuide