Presumption of conformity
The presumption of conformity is the most convenient route to the CE marking. Under the CRA it is still closed, because no standard has been published in the Official Journal. That changes the assessment route for important products.
Presumption of conformity is the legal assumption that a product meets the essential requirements if the manufacturer fully applies a harmonised standard whose reference is listed in the Official Journal of the EU. The authority then has to prove the opposite.
Definition in the Regulation
Article 27(1) CRA links the presumption to harmonised standards whose references have been published in the Official Journal, and only for the requirements the standard covers. As a fallback, Article 27(2) allows the Commission to adopt common specifications by implementing act, but only if the standardisation request has not been accepted, has not been delivered on time or has not been delivered in line with the request. European cybersecurity certificates can also give rise to a presumption; according to its implementation page, the Commission plans a delegated act on this for the fourth quarter of 2026.
As of October 2026, no harmonised standard for the CRA has been cited in the Official Journal. According to secondary sources, EN 40000-1-1 and EN 40000-1-2 have passed the formal vote, ratification is announced for 2 November 2026 and citation is still pending. The Commission has not adopted any common specifications.
What it means for manufacturers
Without the presumption, every manufacturer has to show for itself that its product meets Annex I. For products in the default category, internal control under module A remains possible; the technical documentation then describes the solutions adopted, as required by Annex VII, point (5). BSI TR-03183-1 or IEC 62443 can serve as guidance, but neither gives a presumption of conformity. For important products in class I the consequences are more serious: under Article 32(2), module A is only allowed there if standards are applied in full, so without a standard the only route is through a notified body. Waiting for standards is not an option; conformity has to be demonstrated from 11 December 2027, with or without them.
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- Harmonised standard
- Conformity assessment
- Important product, class I
- Notified body
- Technical documentation