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8.1 Internal Control (Module A)

Procedure

The Internal Control pursuant to Annex VIII, Module A, CRA is the simplest Conformity Assessment procedure. The manufacturer assesses independently whether its product meets the essential requirements.

APPLICABILITY

Module A is applicable for:

  • Standard products (not listed in Annex III or IV)
  • Class I -- only where harmonised standards are applied in full

For Class II and Critical, Module A is not sufficient.

Internal Control Process

1. Prepare Technical Documentation

In accordance with Annex VII CRA, complete technical documentation must be available:

  • [ ] Product description (Template)
  • [ ] Security architecture (Reference)
  • [ ] Cybersecurity Risk Assessment (Template)
  • [ ] SBOM (machine-readable, CycloneDX)
  • [ ] Description of vulnerability handling
  • [ ] Applied standards and norms
  • [ ] Test results

2. Requirements Review (Annex I)

Review each requirement from Annex I and document conformity:

Part I -- Security Requirements:

No.RequirementCompliantEvidence
1Appropriate level of cybersecurity[Reference to documentation]
2No known exploitable vulnerabilitiesCVE Monitor + Trivy Scan
3.1Protection of confidentiality[Encryption, access control]
3.2Protection of integrity[Cosign, checksums]
3.3Protection of availability[Resilience measures]
4Secure default configuration[Security-by-Default]
5Protection against unauthorised access[Authentication, authorisation]
6Minimisation of the attack surface[Minimal services, ports]
7Confidentiality of stored data[Encryption]
8Integrity of stored data[Integrity checks]
9Data minimisation[Only necessary data]
10Availability of essential functions[Resilience]
11Minimisation of adverse impact[Logging, monitoring]
12Security-relevant information[Logging, audit trail]
13Secure update capability[Update mechanism]

Part II -- Vulnerability Handling:

No.RequirementCompliantEvidence
1Identify and document vulnerabilities (SBOM)SBOM Lifecycle
2Remediate vulnerabilities without delayPatch Management
3Regular testing and reviewsCI/CD Security Scans
4Public disclosure of remediated vulnerabilitiesSecurity Advisories
5Coordinated vulnerability disclosureCVD Policy
6Provide security updatesUpdate mechanism
7Timely provision of updatesPatch Management SLAs
8Point of contact for vulnerability reportsSECURITY.md

3. Issue the EU Declaration of Conformity

Following a successful review:

  • Prepare the EU Declaration of Conformity in accordance with Annex V (Template)
  • Sign by an authorised person
  • Archive in the repository

4. CE Marking

  • Affix the CE marking on the product or its packaging
  • For software: Display in the documentation and, where applicable, in the UI
  • Must be visible, legible, and indelible

5. Retain Documentation

  • Technical documentation: 10 years after placing on the market
  • EU Declaration of Conformity: 10 years after placing on the market
  • Storage location: This repository (Git-versioned)

Checklist: Module A -- Internal Control

  • [ ] Product Classification completed (Standard or Class I with harmonised standards)
  • [ ] Technical documentation complete (Annex VII)
  • [ ] Cybersecurity Risk Assessment performed
  • [ ] Annex I Part I -- all requirements reviewed and documented
  • [ ] Annex I Part II -- all requirements reviewed and documented
  • [ ] SBOM generated and archived
  • [ ] Vulnerability handling process established
  • [ ] EU Declaration of Conformity prepared and signed
  • [ ] CE marking affixed
  • [ ] Documentation archived (10-year retention)

Documentation licensed under CC BY-NC 4.0 · Code licensed under MIT