IEC 62304 Edition 2 — the actual status

IEC 62304 Ed. 2 · Committee draft stage · As of: July 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Where the "August 2026" date comes from — and why it is outdated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 can no longer hold: after CD1, a second committee draft became necessary. Two voting stages (CDV and FDIS) still lie ahead, each involving multi-month ballot periods plus revision work. A forecast is not a deadline — IEC forecasts are reset 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 been close to the finish line once before — and failed the ballot. 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). The standard's drafting team itself notes that many changes are likely before the CDV ballot — a draft is not final.

• 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. Do not derive urgency from the MDR: EN 62304 is not harmonised under the MDR anyway — the most recent updates to the harmonised standards lists (January 2026) do not include it. It applies via Annex I, section 17.2 as state of the art. An edition change does not alter that mechanism at first.
3. Keep your documentation structured: If you map each document cleanly to the standard's clauses today and keep your classification rationale traceable, a future edition change becomes a mapping (A → I, B+C → II) instead of a rewrite. Based on today's status, that is the only Edition 2 preparation worth doing.
4. Watch milestones, not dates: The signals that matter are the CD2 circulation, the CDV ballot, and the FDIS. Only the FDIS makes content largely stable. 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. As common market practice, notified bodies expect a transition within roughly two to three years after a new edition is published. With publication in 2028–2029, the practical transition reality would sit closer to 2030 or later. Both are assessments, not fixed deadlines.

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

The mapping per the draft is unambiguous: class A would become Level I, classes B and C would become Level II. A well-reasoned classification today therefore carries that mapping directly. Note that the associated obligations are set to change — particularly for today's class A and class B software (see above). That, too, is draft status and no reason to change your current classification practice.

How will I know when the status changes?

The next procedural steps are the circulation of CD2, then the CDV ballot and the FDIS. We track the standardisation process and update this article at each of those milestones. The stated status of this article is July 2026.