FAQEUCyber Resilience Act

EU Cyber Resilience Act FAQ Harmonised Standards and Common Specifications

Understand when CRA harmonised standards, common specifications, and European cybersecurity certification schemes help prove conformity, and where that evidence stops.

For product, engineering, certification, legal, and compliance teams preparing CRA technical documentation and conformity assessment routes.

Author
Sorena AI
Published
Mar 10, 2026
Updated
Mar 10, 2026
Questions
21

Structured answer sets in this page tree.

Primary sources
4

Cited legal and guidance references.

Publication metadata
Sorena AI
Published Mar 10, 2026
Updated Mar 10, 2026
Overview

The Cyber Resilience Act uses harmonised standards, common specifications, and selected European cybersecurity certification schemes as evidence tools. They can create presumption of conformity for the CRA requirements they cover, but they do not replace the legal requirements, the manufacturer's cybersecurity risk assessment, or the need to document gaps.

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21 of 21 questions
Question 1

What are harmonised standards, common specifications, and European cybersecurity certification schemes under the CRA?

They are technical conformity tools for showing how a product with digital elements and the manufacturer's processes meet the CRA's essential cybersecurity requirements.

Harmonised standards are European standards requested and assessed through the EU standardisation system. Common specifications are Commission implementing acts that can be used only as an exceptional fallback where the Article 27 conditions are met. European cybersecurity certification schemes can support CRA conformity only to the extent the relevant certificate or EU statement of conformity covers the CRA requirements.

Citations
Cyber Resilience Act

Article 27 establishes the CRA legal effects for harmonised standards, common specifications, and European cybersecurity certification schemes.

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Question 2

Are harmonised standards mandatory under the Cyber Resilience Act?

No. Applying harmonised standards is voluntary, but the manufacturer must still demonstrate conformity with the CRA's essential cybersecurity requirements.

If a manufacturer does not use a relevant harmonised standard, or uses only part of it, the technical documentation needs to explain the other solutions and technical specifications used for the requirements not covered by the standard.

Citations
Cyber Resilience Act

Annex VII point 5 requires technical documentation to list applied harmonised standards or describe other solutions.

Question 3

Does every European, ISO, IEC, or ETSI standard create CRA presumption of conformity?

No. For a harmonised standard to create CRA presumption of conformity, its reference must be published in the Official Journal of the European Union for the relevant coverage.

A non-harmonised international, European, ISO, IEC, or ETSI standard may still be useful evidence, but it does not by itself create CRA presumption of conformity. The Blue Guide also warns that where a European standard is based on ISO or IEC text, the presumption attaches to the European version published by reference in the OJEU, not automatically to the source international text.

Citations
Cyber Resilience Act

Article 27(1) ties CRA presumption of conformity for harmonised standards to OJ-published references.

Blue Guide 2022

Blue Guide sections 4.1.2.2 and 4.1.2.3 explain OJEU publication and the European-version limit.

Question 4

What does CRA presumption of conformity mean in practice?

It means authorities should presume conformity with the specific CRA essential cybersecurity requirements covered by the applied harmonised standard, common specification, or qualifying certification evidence.

The presumption is not product-wide unless the applied conformity tool covers all relevant CRA requirements and risks for that product and the manufacturer's processes. If coverage is partial, the presumption is partial.

Citations
Cyber Resilience Act

Article 27(1), 27(5), and 27(8) limit presumption to the essential requirements covered by the relevant tool.

Blue Guide 2022

Blue Guide section 4.1.2.2 explains that the scope of presumption depends on the requirements the standard aims to cover.

Question 5

Do CRA harmonised standards replace the manufacturer's cybersecurity risk assessment?

No. The cybersecurity risk assessment remains the starting point for deciding which CRA essential requirements are relevant to the product.

The Commission FAQ says that even when a harmonised standard is used, the manufacturer remains responsible for assessing product risks, selecting suitable standards or other specifications, and checking whether the standard covers all relevant risks.

Citations
Cyber Resilience Act

Article 13(2) and Annex VII require the manufacturer's cybersecurity risk assessment and its inclusion in technical documentation.

Question 6

What if a CRA harmonised standard covers only part of the product or only part of the requirements?

Then only that part benefits from presumption of conformity.

For the remaining requirements or risks, the manufacturer must use other technical specifications or solutions, explain them in the technical documentation, and show why those solutions meet the applicable CRA requirements.

Citations
Blue Guide 2022

Blue Guide section 4.1.2.3 confirms that partial application gives presumption only to the covered extent.

Question 7

What did the CRA standardisation request M/606 ask CEN, CENELEC, and ETSI to develop?

The Commission says M/606 requests a set of harmonised standards in support of CRA compliance, with both horizontal and vertical standards.

Horizontal standards are intended to provide a common framework, methodology, taxonomy, and processes such as vulnerability handling. Vertical standards are product-specific and focus on risks tied to particular intended purposes and reasonably foreseeable uses, especially for important and critical product categories in CRA Annexes III and IV.

Citations
Question 8

Does the CRA standardisation request itself create presumption of conformity?

No. M/606 starts and frames the standards-development work; it is not the same as an OJ-published harmonised standard.

Even after an ESO adopts a European standard, Article 27(6) requires the Commission to assess it before publishing its reference in the Official Journal. Until the relevant reference is published, the standard does not create CRA presumption of conformity.

Citations
Cyber Resilience Act

Article 27(6) requires Commission assessment before OJ publication of a harmonised standard reference.

Blue Guide 2022

Blue Guide section 4.1.2.3 says OJEU publication starts the presumption and is not automatic.

Question 9

What happens under the CRA if no relevant harmonised standard exists yet?

The product can still be compliant, but the manufacturer must demonstrate conformity by other means.

The absence of a harmonised standard can also affect route selection. For important products of class I, if relevant harmonised standards, common specifications, or qualifying certification schemes do not exist, Article 32(2) requires a third-party conformity assessment route for the corresponding essential cybersecurity requirements.

Citations
Cyber Resilience Act

Article 32(2) sets the class I route consequence when relevant harmonised standards, common specifications, or schemes do not exist or are not applied.

Blue Guide 2022

Blue Guide section 4.1.3 explains that manufacturers may use other means but must demonstrate conformity themselves.

Question 10

When can the Commission adopt CRA common specifications?

Only in the fallback situations set out in Article 27.

The Commission may adopt common specifications after it has requested harmonised standards and the request was not accepted, the standards were not delivered on time, or the standards do not comply with the request. Article 27 also requires that no relevant OJ-published harmonised-standard reference exists and no such reference is expected within a reasonable period.

Citations
Cyber Resilience Act

Article 27(2)-(4) defines the conditions and consultation steps for common specifications.

Question 11

Are CRA common specifications a general mandatory substitute for harmonised standards?

No. Common specifications are an exceptional fallback tool, not the normal first-line standardisation route.

If common specifications are adopted and applied, they can create presumption of conformity for the CRA requirements they cover. If a manufacturer does not apply them, Annex VII still requires the technical documentation to describe the alternative solutions and relevant technical specifications used.

Citations
Cyber Resilience Act

Article 27(2) and 27(5) define common specifications as fallback implementing acts that can create presumption for covered requirements.

Cyber Resilience Act

Annex VII point 5 requires documentation of other solutions when common specifications are not applied.

Question 12

Do CRA common specifications stay in place once a relevant harmonised standard is published?

Not for the overlapping essential cybersecurity requirements.

When the reference of a harmonised standard is published in the Official Journal, Article 27(6) requires the Commission to repeal the common specifications, or parts of them, that cover the same CRA requirements.

Citations
Cyber Resilience Act

Article 27(6) requires repeal of overlapping common specifications after OJ publication of the relevant harmonised standard reference.

Question 13

Can a manufacturer rely on non-harmonised standards or its own technical specifications instead?

Yes, but that route does not carry the same presumption.

The Blue Guide says manufacturers may use other standards, non-OJ European standards, international standards, other technical specifications, or their own specifications. The practical consequence is a heavier evidence burden: the technical file must show in more detail how those choices meet the CRA requirements.

Citations
Blue Guide 2022

Blue Guide section 4.1.3 lists other possibilities and explains the additional demonstration burden.

Cyber Resilience Act

Annex VII point 5 requires a list of other relevant technical specifications when harmonised standards or common specifications are not applied.

Question 14

How do European cybersecurity certification schemes interact with CRA presumption of conformity?

They can create presumption of conformity only for the CRA requirements covered by the certificate or EU statement of conformity.

Article 27(8) gives this limited presumption for products and manufacturer processes covered by a European cybersecurity certification scheme under Regulation (EU) 2019/881. Article 27(9) separately lets the Commission specify schemes that can be used to demonstrate CRA conformity; where such a scheme issues a European cybersecurity certificate at assurance level at least substantial, the manufacturer does not have to carry out a separate third-party CRA conformity assessment for the corresponding requirements.

Citations
Cyber Resilience Act

Article 27(8)-(9) defines certification-scheme presumption and the assurance-level effect for corresponding third-party CRA assessment duties.

Question 15

Does any EU cybersecurity certificate automatically replace CRA conformity assessment?

No. The certificate must be under a relevant European cybersecurity certification scheme, must cover the corresponding CRA requirements, and Article 27(9) requires the Commission to specify which schemes can be used to demonstrate CRA conformity.

A certificate or EU statement of conformity that covers only some requirements gives evidence only for those requirements. It does not prove unrelated CRA requirements, unsupported product functions, vulnerability-handling processes, or technical documentation completeness.

Citations
Cyber Resilience Act

Article 27(8)-(9) limits certificate effect to covered requirements and Commission-specified schemes.

Cyber Resilience Act

Annex VII point 5 still requires technical documentation to identify applied certification schemes and parts applied.

Question 16

Can important or critical CRA products be compliant without harmonised standards?

Yes, because harmonised standards are voluntary. But for important and critical products, route selection may change.

For important products of class I, Article 32(2) moves the corresponding requirements into Module B plus C or Module H if the manufacturer has not applied, has applied only in part, or cannot use relevant harmonised standards, common specifications, or qualifying certification schemes at assurance level at least substantial. Class II and critical products have their own third-party or certification routes under Article 32.

Citations
Cyber Resilience Act

Article 32(2)-(4) sets conformity assessment routes for class I, class II, and critical products.

Question 17

Can a manufacturer integrate important or critical components that were not designed using harmonised standards?

Yes. The Commission FAQ says manufacturers may integrate important or critical components that were not designed in accordance with harmonised standards, whether or not such standards are available.

That does not remove the integrator's CRA work. The manufacturer of the final product still needs to assess component risks, decide whether the final product itself has the core functionality of an important or critical category, and keep technical documentation showing how the final product meets the CRA requirements.

Citations
Question 18

What must CRA technical documentation say about harmonised standards, common specifications, and certification schemes?

It must identify the conformity tools applied in full or in part, and it must identify the gaps.

Annex VII requires a list of applied OJ-published harmonised standards, Article 27 common specifications, and European cybersecurity certification schemes. If they are partly applied, the documentation must specify which parts. If they are not applied, it must describe the solutions adopted to meet the CRA requirements and list other relevant technical specifications.

Citations
Cyber Resilience Act

Annex VII point 5 gives the specific documentation fields for standards, common specifications, certification schemes, partial application, and alternatives.

Cyber Resilience Act

Article 31 requires technical documentation to contain the means used to ensure CRA conformity and to be kept updated where appropriate.

Question 19

What happens if CRA standards, common specifications, or certification schemes change after series production starts?

The manufacturer must take those changes into account for continuing conformity.

CRA Article 13(14) requires procedures for series production to remain in conformity and specifically mentions changes in harmonised standards, common specifications, and certification schemes by reference to which conformity is declared or verified. The Blue Guide adds that revised harmonised standards may have OJEU coexistence periods, after which only the revised standard gives presumption for new conformity assessments.

Citations
Cyber Resilience Act

Article 13(14) requires manufacturers to account for changes to standards, common specifications, or certification schemes used for conformity.

Blue Guide 2022

Blue Guide section 4.1.2.5 explains withdrawal dates and coexistence periods for revised harmonised standards.

Question 20

Can OJ-published CRA harmonised standards be restricted, withdrawn, or challenged?

Yes. OJ publication creates the legal effect, but that legal effect can be restricted, prevented, or withdrawn.

The Blue Guide explains that the Commission may publish a reference with restrictions or later maintain, restrict, or withdraw the reference. Under the CRA safeguard process, if non-compliance is attributed to shortcomings in harmonised standards, common specifications, or certification schemes, the Commission may trigger the relevant standardisation objection or amendment process.

Citations
Blue Guide 2022

Blue Guide sections 4.1.2.4 and 4.1.2.5 explain restriction, withdrawal, and revision of harmonised-standard references.

Cyber Resilience Act

Articles 54(6)(b) and 55(3)-(5) address non-compliance attributed to shortcomings in standards, schemes, or common specifications.

Question 21

What evidence limits should CRA teams record when relying on standards, common specifications, or certification schemes?

Record the exact version, OJ reference status where relevant, requirements covered, parts applied, product functions covered, processes covered, tests or assessments performed, and remaining risks or requirements handled by other means.

The key evidence limit is coverage. A standard, common specification, certificate, or EU statement of conformity supports only the CRA requirements it covers. Technical documentation should therefore map each applicable Annex I requirement to the applied conformity tool or to another documented solution, rather than treating a standard name or certificate as blanket proof.

Citations
Cyber Resilience Act

Annex VII point 5 supports requirement-by-requirement documentation of applied tools, parts applied, alternatives, and technical specifications.

Primary sources

References and citations

eur-lex.europa.eu
Referenced sections
  • Blue Guide sections 4.1.2.4 and 4.1.2.5 explain restriction, withdrawal, and revision of harmonised-standard references.
"withdrawal, restriction or prevention"
data.europa.eu
Referenced sections
  • Annex VII point 5 supports requirement-by-requirement documentation of applied tools, parts applied, alternatives, and technical specifications.
"a list of the harmonised standards applied in full or in part"
ec.europa.eu
Referenced sections
  • Commission FAQ section 4.1.7 supports recording uncovered risks and requirements when standards are partial or not used.
"indicate in their technical documentation how the compliance is reached"
digital-strategy.ec.europa.eu
Referenced sections
  • The Commission CRA standardisation page describes M/606 and the horizontal/vertical split.
"standardisation request M/606, containing a set of 41 standards"
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