1) Confirm the product is a PDE and is commercially made available in the EU market.

2) Define the product's core functionality (not only marketing category).

3) Test mapping against Annex III (important) and Annex IV (critical).

4) Assign likely conformity pathway and record assumptions for legal review.

  • Default category: Most products; manufacturer self-assessment possible when Annex III/IV does not apply.
  • Important (Annex III): Class I and Class II with stricter conformity conditions.
  • Critical (Annex IV): Mandatory notified body assessment pathway.
  • - Product line treated as one class despite distinct core functions.
  • - Backend/service dependencies excluded from scoping rationale.
  • - No evidence log for assumptions and source references.
  • - Conformity route selected before classification evidence exists.

A versioned classification record per product line, with category decision, conformity route, and unresolved legal questions.

Use this as input to your technical documentation and release gating process.

Next: Article 14 reporting Back to CRA fundamentals Book classification review

Primary sources: Regulation (EU) 2024/2847, European Commission CRA page. This guide is informational and not legal advice.