Artifact GuideEU

Cyber Resilience Act conformity assessment and CE marking

A source-grounded guide for manufacturers deciding how to demonstrate CRA conformity before placing products with digital elements on the EU market.

Use it to align product classification, standards coverage, technical documentation, the EU declaration of conformity, and CE marking controls.

Author
Sorena AI
Published
Mar 4, 2026
Updated
May 25, 2026
Sections
6

Structured answer sets in this page tree.

Primary sources
3

Cited legal and guidance references.

Publication metadata
Sorena AI
Published Mar 4, 2026
Updated May 25, 2026
Overview

Under the Cyber Resilience Act, CE marking is the visible outcome of a completed conformity assessment. The route is not chosen by convenience alone: it depends on the product category, the coverage of harmonised standards or other recognised conformity bases, and whether the manufacturer can evidence both product cybersecurity requirements and vulnerability-handling processes.

Section 1

Start with the product category and core functionality

Classify the product before choosing a route. The CRA separates products with digital elements into the default category, important products of class I, important products of class II, and critical products. Commission FAQ grounding explains that important or critical classification turns on the product's core functionality, not merely on the presence of an important or critical component inside a larger product.

This distinction matters for finished-product systems. Integrating a browser, secure element, operating system component, or other listed component does not automatically pull the whole finished product into that component's conformity route. The finished product still needs its own classification and cybersecurity risk assessment.

  • Record the intended purpose, reasonably foreseeable use, deployment context, and product functions used for classification.
  • Map the product against Annex III important-product categories and Annex IV critical-product categories before deciding whether third-party assessment is required.
  • Use technical category descriptions and official guidance where available; avoid relying only on marketing names such as router, gateway, platform, agent, or app.
  • Keep the classification rationale in the technical documentation so the selected route can be defended to a notified body or market surveillance authority.
Section 2

Apply Article 32 route logic

Article 32 recognises internal control under Module A, EU-type examination under Module B followed by conformity to type under Module C, full quality assurance under Module H, and qualifying European cybersecurity certification schemes where the CRA makes them available for that purpose.

Default-category products can use Module A. Important class I products can use Module A only where the relevant harmonised standards, common specifications, or European cybersecurity certification schemes are applied for the relevant requirements. Where those instruments are missing, only partly applied, or do not cover the relevant requirements, the manufacturer needs Module B plus C or Module H for those requirements.

  • Module A: manufacturer draws up technical documentation, verifies conformity, affixes CE marking, and declares compliance on its own responsibility without notified body participation.
  • Module B plus C: a notified body examines design, development, technical documentation, supporting evidence, specimens, and vulnerability-handling processes; the manufacturer then controls conformity to the approved type in production.
  • Module H: a notified body assesses and surveils a full quality system covering design, development, production, final inspection, testing, and product cybersecurity controls.
  • Important class II products generally require Module B plus C, Module H, or a qualifying certification route; Article 32 also contains a specific free and open-source software rule where public technical documentation is provided.
  • Critical products depend first on whether a European cybersecurity certification scheme has been made mandatory under Article 8; otherwise, the Article 32 class II routes are the fallback route set.
Section 3

Build the technical file around evidence, not headings

Annex VII sets the minimum technical documentation content. It is the file that lets the manufacturer, a notified body, or a market surveillance authority assess conformity against Annex I product requirements and Annex I vulnerability-handling requirements.

The file should connect classification, risk assessment, requirements, standards coverage, tests, software versions, vulnerability processes, support-period reasoning, and the EU declaration of conformity. Where standards, common specifications, or certification schemes are not used in full, the file needs to identify what was applied and describe the alternative solutions used to meet the essential requirements.

  • Product description: intended purpose, relevant software versions, hardware or architecture information where applicable, and user instructions.
  • Lifecycle processes: design, development, production, maintenance, and vulnerability handling, including how third-party and open-source components are controlled.
  • Cybersecurity risk assessment: assumptions, threat model, intended and foreseeable use, risk treatment, tests, and justifications for any Annex I requirement treated as not applicable.
  • Standards and conformity basis: harmonised standards, common specifications, certification schemes, or other technical specifications applied in full or in part.
  • Evidence package: test reports, SBOM where applicable, support-period rationale, declaration copy, version history, and change-control records for modifications that may affect conformity.
Recommended next step

Turn CRA CE marking work into an operational assessment

Assessment Autopilot can turn Cyber Resilience Act conformity assessment and CE marking work into route decisions, evidence requests, review checkpoints, and release controls inside Sorena.

Section 4

Treat notified-body review as product and process review

For Module B plus C, the notified body does more than read a binder. Annex VIII expects assessment of the technical design and development of the product, supporting evidence, specimens of critical parts, and the manufacturer's vulnerability-handling processes.

For Module H, the notified body assesses the full quality system and checks whether the manufacturer can consistently identify applicable CRA requirements, perform the necessary examinations, and keep products compliant through design and production. That makes change control, release governance, and vulnerability-management evidence central to the assessment.

  • Maintain a route decision record that shows the category, route, applicable standards or schemes, and reasons why third-party assessment is or is not required.
  • Trace Annex I requirements to design controls, security tests, vulnerability-handling procedures, and release gates.
  • Escalate product changes that may affect conformity, the approved type, or certificate validity before release.
  • Keep evidence that production units, software releases, and updates remain aligned with the assessed design and documented controls.
Section 5

Issue the declaration before relying on CE marking

After a positive conformity assessment, the manufacturer draws up the EU declaration of conformity under Article 28 and affixes CE marking under Articles 29 and 30. The declaration is the manufacturer's responsibility statement that the product with digital elements complies with the CRA.

The CRA allows either the full declaration following Annex V or a simplified declaration following Annex VI that gives the internet address for the full declaration. Where several EU harmonisation acts require an EU declaration for the same product, Article 28 requires a single declaration covering the applicable acts.

  • Use Annex V content: product identification, manufacturer details, object of the declaration, statement of sole responsibility, applicable Union law, standards or specifications used, notified body details where applicable, and signature.
  • Keep the declaration and technical documentation available to national authorities for ten years after placing on the market or for the support period, whichever is longer.
  • Provide the declaration in the language or languages required by the Member State where the product is placed or made available on the market.
  • Do not sign the declaration or apply CE marking until the selected conformity route has produced a positive result.
Section 6

Control where and how CE marking appears

CRA CE marking must be visible, legible, and indelible. For software products, Article 30 allows CE marking either on the EU declaration of conformity or on the website accompanying the software product, provided the relevant section is easily and directly accessible to consumers.

If a notified body is involved in the conformity assessment route, Article 30 requires its identification number to appear after the CE marking. Market surveillance authorities can treat missing, wrongly affixed, or unsupported CE marking as formal non-compliance and require corrective action.

  • Define the CE marking location for hardware, packaging, instructions, declaration, website, or software distribution page before release approval.
  • Check size, visibility, legibility, and permanence against CRA and Blue Guide CE-marking rules.
  • Add the notified body's identification number where the selected CRA route requires notified body involvement.
  • Keep screenshots, artwork approvals, declaration versions, product labels, and release records showing the CE marking used for each placed-on-market version.
Primary sources

References and citations

data.europa.eu
Referenced sections
  • Supports the CRA route logic in Article 32, EU declaration rules in Article 28, CE marking rules in Articles 29 and 30, and technical documentation requirements in Article 31 and Annex VII.
"products with digital elements should bear the CE marking"
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