FAQEUCyber Resilience Act

EU Cyber Resilience Act FAQ Module B+C

Use this CRA FAQ to understand the two-step module B+C route, what the notified body examines, what production-control duties remain with the manufacturer, and when post-certificate changes require further approval.

Built for certification, engineering, legal, and compliance teams using or reviewing the CRA type-examination route.

Author
Sorena AI
Published
Mar 10, 2026
Updated
Mar 10, 2026
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32

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Primary sources
4

Cited legal and guidance references.

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

Module B+C combines notified-body type examination with manufacturer-led production control. This FAQ focuses on what must be submitted for EU-type examination, what the certificate covers, what module C adds, and how later changes, language rules, CE marking, and audits work under this route.

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32 of 32 sections
Section 1

What is module B+C under the CRA?

Module B+C is a two-step conformity-assessment route.

Module B is EU-type examination by a notified body. Module C is conformity to the approved type based on the manufacturer's internal production control. Together, they cover both the examination of the product type and the manufacturer's obligation to keep actual production in line with that approved type.

Citations
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Section 2

When is module B+C mandatory?

Module B+C is one of the mandatory third-party routes for:

- important products of class I where Article 32(2) requires third-party assessment for the relevant requirements

- important products of class II

- critical products, unless the applicable certification route under Article 8(1) applies

Section 4

Does module B+C always involve a notified body?

Yes.

Module B is the notified-body part of the route. Module C then follows with the manufacturer's own internal production control against the approved type.

Citations
Section 5

How many notified bodies can be involved in one module B application?

Only one.

The manufacturer must lodge the EU-type examination application with a single notified body of its choice and must declare that the same application has not been lodged with any other notified body.

Citations
Section 6

What does the manufacturer have to submit for module B?

The application must include:

- the manufacturer details and, where relevant, the authorised representative's details

- a declaration that the same application has not been lodged with another notified body

- technical documentation that allows conformity to be assessed, including an adequate analysis and assessment of the risks

- supporting evidence for the adequacy of the technical design, development solutions, and vulnerability-handling processes

Where necessary, the supporting evidence must include test results from the manufacturer's own laboratory or another testing laboratory acting on its behalf and under its responsibility.

Citations
Section 7

Does module B cover only the product's technical design, or also vulnerability handling?

It covers both.

EU-type examination is not limited to the product's technical design and development. The notified body also examines the vulnerability-handling processes put in place by the manufacturer against Part II of Annex I.

Citations
Section 8

Does the notified body assess only documents, or also specimens and tests?

It assesses both.

Annex VIII Part II requires examination of the technical documentation and supporting evidence, plus examination of specimens of one or more critical parts of the product. The notified body must also carry out appropriate examinations and tests, or have them carried out.

Citations
Section 9

What exactly does the notified body check during module B?

The notified body checks:

- whether the technical documentation and supporting evidence are adequate

- whether the examined specimens match the documentation

- which elements were designed and developed using relevant harmonised standards or technical specifications and which were not

- whether the manufacturer's chosen solutions satisfy the applicable essential cybersecurity requirements

Citations
Section 10

Can module B tests be carried out at the manufacturer's site or elsewhere?

Yes.

Annex VIII Part II point 4.5 says the notified body and the manufacturer agree on the location where the examinations and tests will be carried out.

Citations
Section 11

What does the manufacturer receive if module B is successful?

The manufacturer receives an EU-type examination certificate.

The certificate identifies the approved type and the vulnerability-handling processes, and it records the conclusions of the examination and any validity conditions.

Citations
Section 12

What happens if the notified body concludes that the type does not comply?

It must refuse to issue the EU-type examination certificate and give detailed reasons for the refusal.

Citations
Section 13

Does the EU-type examination certificate approve only the type, or also the manufacturer's vulnerability-handling processes?

It covers both.

Annex VIII Part II point 6 ties the certificate to both the approved type and the examined vulnerability-handling processes. That is why later modifications to either can matter for certificate validity.

Citations
Section 14

What does module C add after module B?

Module C is the production-control step.

After obtaining the EU-type examination certificate, the manufacturer must ensure and declare that the products actually manufactured remain in conformity with the approved type and continue to satisfy the essential cybersecurity requirements.

Citations
Section 15

Does module C mean the notified body supervises the production phase directly?

Not in the way module H does.

Under module C, the manufacturer itself must take the necessary measures so that production and its monitoring ensure conformity with the approved type. The Commission FAQ makes the same point: the manufacturer cannot rely on an approved design if actual production drifts into non-compliance.

Citations
Section 16

What must the manufacturer do under module C before placing products on the market?

The manufacturer must:

- ensure that production conforms to the approved type

- affix the CE marking to each individual compliant product

- draw up a written declaration of conformity for the product model

Citations
Section 17

Under module C, is the declaration of conformity for each individual product or for the product model?

It is for the product model.

Annex VIII Part III point 3.2 requires a written declaration of conformity for a product model. That differs from module A wording, which refers to each product with digital elements.

Citations
Section 18

Does the CE marking still have to go on each individual product under B+C?

Yes.

Even though the declaration under module C is for the product model, the CE marking must still be affixed to each individual product with digital elements that conforms to the approved type.

Citations
Section 19

What happens if the approved type or vulnerability-handling processes change after certification?

The manufacturer must inform the notified body that holds the technical documentation relating to the certificate of any modifications that may affect conformity or the conditions for validity of the certificate.

Those modifications require additional approval in the form of an addition to the original EU-type examination certificate.

Citations
Section 20

Is module B+C reassessment required only for "substantial modifications"?

Not only for that label.

Annex VIII Part II point 7 is framed more broadly: the trigger is any modification to the approved type or the vulnerability-handling processes that may affect conformity with Annex I or the conditions for validity of the certificate.

Citations
Section 21

Does module B+C include surveillance after the certificate is issued?

Yes, but it is limited.

The notified body must carry out periodic audits to ensure that the vulnerability-handling processes in Part II of Annex I are implemented adequately. This is not the same as the broader quality-system surveillance under module H.

Citations
Section 22

Who gets informed about issued, refused, withdrawn, suspended, or restricted EU-type examination certificates?

The notified body must inform its notifying authorities and the other notified bodies about those certificate outcomes.

The Commission and Member States can also obtain copies of the certificates and, on request, copies of the technical documentation and examination results.

Citations
Section 23

How long must the manufacturer keep B+C records?

The manufacturer must keep:

- the EU-type examination certificate, its annexes and additions, together with the technical documentation

- the declaration of conformity for the product model

Those records must be kept at the disposal of national authorities for 10 years after the product is placed on the market or for the support period, whichever is longer.

Citations
Section 24

Can an authorised representative handle some module B+C steps?

Yes, but only where the mandate expressly covers them.

Under Annex VIII Part II point 11, the authorised representative may lodge the module B application and fulfil the obligations relating to modifications and record retention. Under Annex VIII Part III point 4, the authorised representative may fulfil the declaration obligations in module C.

Citations
Section 25

Can important free-and-open-source software still use module B+C?

Yes.

Article 32(5) allows manufacturers of Annex III products qualifying as free and open-source software to use one of the procedures listed in Article 32(1), provided the technical documentation is made public at the time of placing on the market. That means they may use module A, but they may also choose module B+C.

Citations
Section 26

Do older EU-type certificates issued under other Union product laws automatically disappear on 11 December 2027?

No.

Article 69(1) provides a transition rule: EU-type examination certificates and approval decisions issued regarding cybersecurity requirements for products with digital elements under other Union harmonisation legislation remain valid until 11 June 2028, unless they expire earlier or that other legislation specifies otherwise.

Section 27

What usually makes a CRA module B+C file workable in practice?

A workable file is one that lets the notified body trace the compliance claim, the supporting design choice, the evidence, and the tested specimen without gaps.

Grounded in Annex VIII Part II and Annex VII, that usually means the application clearly identifies the applicable requirements, includes the risk analysis and assessment, explains any reliance on or departure from harmonised standards or technical specifications, and contains the supporting evidence and test results needed for the notified body's examination.

Citations
Section 28

Does module B+C require the notified body's identification number next to the CE marking?

No.

Under Article 30(4), the CE marking is followed by the notified body's identification number only where that body is involved in the conformity assessment procedure based on module H. Under module B+C, the manufacturer still affixes the CE marking to each individual compliant product under module C, but the CRA does not require a notified-body number next to that marking.

Citations
Section 29

In what language can module B+C technical documentation and correspondence be submitted to the notified body?

They must be in an official language of the Member State where the notified body is established, or in another language acceptable to that body.

That rule applies to the technical documentation and correspondence relating to any CRA conformity assessment procedure, including module B+C.

Citations
Section 30

Does every change after certification have to go back to the notified body?

No.

The legal trigger in Annex VIII Part II point 7 is any modification to the approved type or the vulnerability-handling processes that may affect conformity with Annex I or the conditions for validity of the certificate. Those changes require additional approval from the notified body in the form of an addition to the original certificate.

The Commission FAQ adds a practical split: substantial modifications require a new assessment by the same or a different notified body and may lead to revision of the certificate, while modifications that do not affect compliance with the CRA requirements are not subject to reassessment by the notified body.

Citations
Section 31

After a substantial modification, does the new module B+C assessment have to start from scratch for unchanged parts?

Not necessarily.

The March 2026 draft guidance says a substantially modified product is treated as a new product and is newly placed on the market. But it also says existing documentation and tests may be re-used for aspects not impacted by the substantial modification, and that where a third-party conformity assessment is performed it should focus on the substantially modified parts. The person placing the substantially modified product on the market still has to justify why unchanged parts can rely on the existing evidence.

Section 32

Do the periodic audits under module B+C cover the whole production system in the same way as module H?

No.

Under Annex VIII Part II point 8, the periodic audit duty is specifically to ensure that the vulnerability-handling processes in Part II of Annex I are implemented adequately. Module C separately leaves production conformity control to the manufacturer. So this is narrower than a module H full-quality-assurance assessment.

Citations
Primary sources

References and citations

data.europa.eu31 citations
Referenced sections
  • Article 32(1)(b), Annex VIII Parts II and III
  • Article 32(2)-(4)
  • Article 32(1)
Show 24 more
  • Annex VIII Parts II and III
  • Annex VIII Part II point 3, point 3.2
  • Annex VIII Part II point 3.1-3.4
  • Annex VIII Part II points 1, 3.3, and 4.1
  • Annex VIII Part II points 2 and 4.1-4.5
  • Annex VIII Part II points 4.1-4.4
  • Annex VIII Part II point 4.5
  • Annex VIII Part II point 6
  • Annex VIII Part III points 1-2
  • Annex VIII Part III point 2
  • Annex VIII Part III points 2 and 3
  • Annex VIII Part III point 3.2
  • Annex VIII Part III point 3.1
  • Annex VIII Part II point 7
  • Annex VIII Part II point 8
  • Annex VIII Part II point 9
  • Annex VIII Part II point 10, Annex VIII Part III point 3.2
  • Annex VIII Part II point 11, Annex VIII Part III point 4
  • Article 32(1), Article 32(5)
  • Article 69(1)
  • Annex VII, Annex VIII Part II points 3 and 4
  • Article 30(4), Annex VIII Part III point 3.1
  • Article 31(4)
  • Annex VIII Part II point 8, Annex VIII Part III point 2
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