Interactive process map

The CRA evidence process, from product idea to end of support

The GAP analysis shows where you stand. This process map shows what to do, and in which order: seven phases in BPMN notation, with every branch by product class and the three-stage reporting chain. Each element names its purpose, article, owner and the document that has to exist at the end.

  • Seven sub-processes to open up — scoping, secure development, vulnerability handling, conformity assessment, documentation, post-market, reporting
  • Every node with its legal basis, owner and evidence artefact — one click, no page-turning through the regulation
  • The assessment route by product class as its own gateway: where self-assessment is enough and where a notified body is mandatory
  • Printable as an A3 landscape poster — the process map for the project wall

Author

Dirk Leopold

Dirk Leopold

Head of Compliance Intelligence

What to expect

  1. Phase 1 — Scoping and classification: scope, role, product class, support period
  2. Phase 2 — Secure development: risk assessment, the 13 requirements of Annex I, SBOM, security testing
  3. Phase 3 — Vulnerability handling: CVD policy, point of contact, monitoring, advisory
  4. Phase 4 — Conformity assessment: module choice by product class, notified body, type examination
  5. Phase 5 — Documentation, EU declaration of conformity and CE marking
  6. Phase 6 — Post-market: updates, market surveillance, substantial modification
  7. Phase 7 — Reporting under Art. 14: 24 hours, 72 hours, 14 days
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