CRA Reference

CE marking

Primary audience:LegalDeadline:

Published on

What the CE marking is — and is not

The CE marking is the manufacturer’s declaration, under its sole responsibility, that the product satisfies all applicable requirements of the Union harmonisation legislation providing for its affixing.

It is not a quality label, not a certification, not a guarantee that no vulnerability exists, and not issued by an authority. It is a unilateral statement, enforceable and punishable if false.

The seven cumulative conditions

Before affixing, in this order:

  1. the applicable Annex I essential requirements are satisfied;
  2. a cybersecurity risk assessment has been carried out and documented;
  3. the Annex VII technical documentation is compiled, SBOM included;
  4. the conformity assessment procedure applicable to the product’s class has been completed;
  5. the Annex V EU declaration of conformity has been drawn up and signed;
  6. the Annex II information and instructions to the user are supplied with the product;
  7. the manufacturer’s identification and the contact point for reporting vulnerabilities appear on the product, its packaging or its accompanying documentation.

A single missing condition makes the affixing irregular.

Rules for affixing

  • Visibly, legibly and indelibly. Where the nature of the product does not allow it, on the packaging and on the accompanying documents.
  • For a software product: on the EU declaration of conformity and, where applicable, on the website accompanying the product, in a place easily accessible from the download or purchase page.
  • Before placing on the market.
  • Where a notified body was involved in the production control phase, its identification number is affixed after the CE marking — by the body itself or by the manufacturer on its instructions.
  • No marking, sign or inscription liable to mislead third parties as to the meaning or form of the CE marking may be affixed beside it.

The commercial gate

No CE marking = no placing on the Union market.

That is the sentence that makes the topic legible to an executive committee. The organisational consequence follows directly: the legal function owns the marking process and must hold a formal right of veto over placing on the market.

That veto is embodied in a conformity review record, signed before affixing, which walks through the fifteen points of the checklist and names who is responsible for each item.

Common mistakes

Mistake Consequence
Affixing the marking “in anticipation”, pending completion of the file Formal non-compliance and an inaccurate declaration
Reusing a previous version’s declaration without updating it The declaration does not cover the product actually placed on the market
Omitting the notified body number where the body was involved Formal non-compliance
Affixing the marking to a product outside CRA scope Misleading marking
Treating the marking as acquired once and for all Any substantial modification reopens the procedure