In brief
The IEC 62304 Edition 2 CD2 has just been sent to the secretariat; CD1 comments are resolved and implemented. On the schedule tracked via the project tracker (BSI / IEC mirror), comment resolution starts on 19 August 2026, the approval stage on 21 October 2026, and publication remains forecast for 2028. Two successive drafts already converge on ending classes A/B/C in favour of two rigor levels, a cloud subclause, and a minimal definition of AI-enabled health software.
Where does the revision timeline stand?
IEC 62304 structures the medical software lifecycle. Edition 2 is not published yet: the text circulates as a Committee Draft. Operational tracking relies on the IEC project tracker (often viewed via the BSI mirror), which shows notably:
- public comment period: closed 12 February 2025;
- comment resolution: starts 19 August 2026;
- approval stage: starts 21 October 2026;
- official IEC publication forecast: 2028.
From the working group, the recent signal is clear: CD2 was sent to the secretariat after all pending CD1 comments were resolved and implemented. Two converging CDs do not make a standard, but they make monitoring useful now.
What CD2 already clarifies
Beyond the calendar, CD2 pushes more homogeneous drafting: consistent use of IEV Part 880 vocabulary, clearer requirements, updated annexes. Maintenance, problem resolution and modification are better articulated, mainly around Clause 6.
Three changes confirmed across two successive drafts
The following points appear stably from one draft to the next. They remain provisional until the standard is published, but they are enough to steer QA/RA monitoring.
Classes → levels
Safety classes A/B/C disappear in favour of two rigor levels. At Level 2, manufacturers document their own justification for methods and the degree of strictness retained.
Cloud services
A new subclause addresses shutting down or migrating cloud services, distinct from classic on-device software. The manufacturer controls when and what of cloud-based change.
AI, minimal definition
Working definition: AI-enabled health software whose functionality essentially depends on data obtained from training. A trained model can itself be a “software unit”, linking data lifecycle and software lifecycle. IEC 62304 stays minimalistic on AI; detailed data lifecycle is left to other IEC TC 62 standards.
Practical impact for QA/RA teams
From 19 August 2026, comment resolution opens. National committees distribute the CD2 PDF and a new comment window. Only comments submitted via the national committee count in the IEC process: a LinkedIn reply or an internal note does not.
On the ground, three useful moves without waiting for 2028: start mapping Class A/B/C → Level 1/2 in documentation, watch the cloud subclause if you host models or SaaS updates, and keep current classification operational while Edition 1 remains the cited reference. For AI Act / SaMD articulation, see also our analysis AI Act and SaMD.
Action plan
- Note tracker milestones: comment resolution from 19 August 2026, approval from 21 October 2026, publication forecast 2028.
- Obtain CD2 via your national committee as soon as distributed, and comment only through the NC channel.
- Sketch a Class A/B/C → Level 1/2 correspondence table for your existing software.
- Identify cloud services and hosted model updates likely covered by the future subclause.
- Check whether your internal “AI-enabled health software” definition aligns with the draft working definition.
- Do not freeze procedures and templates on CD2 yet: document expected gaps, not a premature switch.
Conclusion
The text remains a draft, but two converging Committee Drafts and a comment-resolution calendar that is starting make the revision an active monitoring topic, not a 2028-only topic. Anticipate the documentation mapping; keep Edition 1 as the operational reference until publication.
FAQ
Is IEC 62304 Edition 2 already published?
No. The text is still a project. The schedule tracked via the IEC project tracker (BSI mirror) indicates a 2028 publication forecast, after comment resolution and the approval stage.
What does CD2 mean in the revision process?
CD2 is the second Committee Draft. The working group indicated that CD2 has just been sent to the secretariat, with pending CD1 comments resolved and implemented.
Are safety classes A/B/C disappearing?
In the last two successive drafts, safety classes are replaced by two rigor levels. At Level 2, manufacturers document their own justification for methods and strictness. This is not yet the published standard.
How do we comment on CD2?
National committees distribute the CD2 PDF and open a comment window. Only comments submitted via the national committee count in the IEC process.
Should we already migrate Class A/B/C documentation?
Do not switch early: the text is still a draft. Starting a Class A/B/C to Level 1/2 mapping now avoids a brutal documentation rebuild at publication.
QARA PULSE analysis based on monitoring of the IEC 62304 Edition 2 revision project (IEC project tracker / BSI mirror, working-group feedback on CD2). Status checked 10 August 2026. This is not personalised legal advice. Draft dates and content can change; rely on official IEC documents and your national committee.