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Clause 4 — Application of this document

Clause 4 explains how manufacturers apply FprEN 40000-1-2:2026. It describes the structural relationship between informative principles (Clause 5) and normative risk management (Clause 6) and lifecycle activities (Clause 7).

What Clause 4 requires​

Clause 4 defines the normative assessment structure used in Clauses 6 and 7. Each subclause follows a standardized five-part layout:

  • Rationale and guidance (Informative): Explains the objective.
  • Input (Normative): Specifies prerequisite documentation and data.
  • Requirement (Normative): Defines mandatory actions, tagged with unique requirement IDs (e.g., RMA-01-RQ-01, CLA-04-RQ-01).
  • Output (Normative): Describes required documentary deliverables.
  • Assessment criteria (Normative): Specifies verification checks. A PASS verdict requires fulfilling all assessment criteria.

How CVD Portal supports compliance​

CVD Portal mirrors this five-part normative structure directly inside the platform:

  • Structured requirement mapping: Every requirement ID from Clauses 6 and 7 is tracked as an explicit control row in the platform Control Register.
  • Prerequisite data tracking: The workspace alerts you when required input documentation is missing before you begin downstream risk management activities.
  • Automated assessment checks: Platform automated checks evaluate your documentation and live configuration against the normative assessment criteria to assign an objective PASS or FAIL verdict.
  • Technical file assembly: The platform automatically compiles all outputs into an audit-ready CRA Annex VII technical file.