IEC 62304 Edition 2 — the actual status

IEC 62304 Ed. 2 · Committee draft stage (CD2 · 62A/1761/CD) · As of: 16 August 2026

Where the "August 2026" date comes from — and why it is outdated

In early 2025, the IEC project overview showed a schedule forecast: comment resolution in March 2026, approval in May 2026, publication on 12 August 2026. That forecast was picked up by industry blogs and has been repeated widely ever since — often unverified, and often paired with advice to prepare for Edition 2 "now".

Procedurally, that date is ruled out: after CD1, a second committee draft became necessary, and it was circulated on 7 August 2026. Only then do the two ballot stages follow, CDV and FDIS, each with a multi-month ballot period plus revision work. How reliable such dates are is something this project demonstrates on itself: its project plan in the IEC registry has already been re-set once in full — the initial plan scheduled publication for 30 April 2027, the current plan schedules it for 26 October 2028, roughly 18 months later. The committee milestone of that new plan, 29 May 2026, was missed as well and only reached on 7 August 2026. A forecast is not a deadline; IEC plan dates are re-set with every procedural step.

Where Edition 2 actually stands

Before publication, an IEC standard passes through fixed stages: CD (committee draft — commenting by the national mirror committees), CDV (committee draft for vote — the first real ballot), FDIS (final draft international standard — the closing ballot), then publication. A draft can fail at either voting stage.

The 2021 precedent is the most important context: Edition 2 has already reached the CDV stage once — and failed there; the project was closed. That is exactly the stage the current draft still has ahead of it. A committee draft is not a guaranteed precursor to publication; it is a working state.

What is set to change, based on the draft

The following points describe the status of the first committee draft (CD1) of early 2025 and the Design Specification approved by the national committees. CD2 neither confirms nor refutes them: the CD2 text is restricted to the national committees, and no new public SC 62A document has appeared since January 2025. That CD2 has been circulated is a procedural fact — not a statement about its content. The standard's drafting team also notes itself that many changes are likely before the CDV ballot.

• Two levels instead of three classes: The software safety classes A/B/C are set to become two "Software Process Rigor Levels" (I and II); clause 4.3 would be renamed "Software process rigor" instead of "Software safety classification". The mapping per the draft: class A → Level I, classes B and C → Level II. The motive is alignment with the two-tier scheme of IEC 81001-5-1.
• Level II as the default: Per CD1, Level II is the default. Level I would only apply where the risk analysis shows the software cannot contribute to a hazardous situation. Software implementing a risk control measure would always be Level II.
• New obligations for today's class A software: Per the draft, ex-class-A software would in future need to document a software architecture and a design specification, and demonstrate release and maintenance planning — activities that today apply only from class B upward, or that would be newly required for all.
• Today's class B would rise to today's class C level: Level II merges the current B and C requirements — for ex-class-B software this would mean additional obligations at today's C level, plus a new static code analysis requirement.

In specific places the draft is still in motion. Example: whether risk control measures outside the software may lower the rigor level is answered differently within the standardisation process — the approved Design Specification says no, while the drafting team's CD1 says yes (with evidence of effectiveness). Details like this can still turn before the FDIS. This is precisely why it is premature to convert processes or documents to Edition 2 content today.

What makes sense to do today

1. Stay on Edition 1: IEC 62304:2006 + A1:2015 is the only citable version — and the version you are audited against. It will remain audit-relevant for years even after Edition 2 is published.
2. Check the harmonisation status at the source: EN 62304 is not on the list of standards harmonised under the MDR — it does not appear in the European Commission's summary list generated on 17 June 2026; that list reflects the state after amending decision (EU) 2026/1231 of 11 June 2026. The same list is where you check whether anything has been added since. Under the repealed Directive 93/42/EEC, EN 62304 was listed (Implementing Decision (EU) 2020/437, Annex I, No. 258); under the MDR it never has been. For software that is part of a device or is a device in itself, the MDR requires in Annex I, section 17.2 that it be "developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation". Annex I does not name a standard that fills that term. Standardisation request M/575 lists EN 62304 in Annex I, Table 1 under No. 203, with a deadline for the adoption of a revised version of 27 May 2028 — a deadline addressed to CEN/CENELEC, not an announcement of publication in the Official Journal. What follows from this for your device is an assessment your RA function makes; this article gives you the references for it, not the assessment.
3. Keep your documentation structured: If you map each document cleanly to the standard's clauses today and keep your classification rationale traceable, any future edition change becomes a mapping exercise instead of a rewrite — regardless of which classification model the final text of the standard settles on. If the draft status holds (A → I, B + C → II), the mapping is trivial on top of that. Based on today's status, that is the only Edition 2 preparation worth doing.
4. Watch milestones, not dates: CD2 has been circulated. The next procedural steps are comment compilation, the CDV ballot and the FDIS. Only the FDIS makes content largely stable; only publication makes it citable. Publication dates without those preceding stages are forecasts, not deadlines.

Frequently asked questions

Do I need to prepare for Edition 2 now?

No — not in the sense of restructuring anything. Plan and document against the applicable Edition 1. Converting processes or documents to a committee draft that still has two ballot stages ahead of it — and whose first attempt failed in 2021 — creates effort without a defensible basis. The preparation that pays off is structural order in your existing documentation, not a premature standards switch.

When will Edition 2 become binding?

There is no official transition period — the standard has not been published. The IEC project plan schedules publication for 26 October 2028; in the initial plan for the same project it stood at 30 April 2027 (plan status 16 August 2026, not a committed date). As common market practice, notified bodies expect a transition within roughly two to three years after a new edition is published. Together that produces an expectation, not a deadline — and the track record of this very project points to later rather than earlier: the committee milestone of 29 May 2026 was missed, and the first attempt failed outright in 2021. Until publication, IEC 62304:2006 + A1:2015 is the only binding version.

Will my current A/B/C classification still hold?

Your current classification holds for as long as Edition 1 holds — and that is unreservedly the case until Edition 2 is published. For the time after that, the draft status foresees a mapping: class A would become Level I, classes B and C would become Level II. Whether CD2 retains that mapping is something we cannot check; the text is not public. Note also that the obligations attached to the levels are set to change — particularly for today's class A and class B software (see above). For your current classification practice, none of this changes anything: it stays as it is.

How current is this article?

The article carries a status date at the top: 16 August 2026. Check that date first, then the content — with any source on this standard, including this one. The standard's status behind this article is held as a dated entry in our regulatory register and checked on a fixed cycle against the IEC project registry, not against industry blogs. The next registry-visible events are the comment compilation on CD2, the CDV ballot and the FDIS. What we do not promise you: that this article is updated on the day such an event happens. What you get instead: a date that tells you how old its status is.