LESSON 16

CE marking, declaration of conformity and market surveillance

Closing the loop: what you sign, what you affix, and what happens when an authority calls.

8 min read video walkthrough

The EU declaration of conformity

A single document, in the required languages, in which you state on your sole responsibility that the essential requirements are met. Annex V sets the content: product identification (name, type, batch or serial), manufacturer name and address, a statement that the DoC is issued under sole responsibility, the object of the declaration allowing traceability (including a photograph where appropriate), references to the relevant Union harmonisation legislation, references to standards or common specifications applied, where applicable the notified body's name, number and certificate reference, and the place, date and signature.

Where the product falls under several Union acts (CRA plus RED plus EMC, typically), issue a single DoC covering all of them, listing each act.

CE marking

Affixed visibly, legibly and indelibly to the product; where that is not possible, to the packaging and the accompanying documentation. Where a notified body was involved in the production control phase, its four-digit identification number follows the mark. Affixing CE marking is the manufacturer's act of taking responsibility — it is not a certificate anyone grants you.

Market surveillance

Each Member State designates market surveillance authorities with powers under Regulation (EU) 2019/1020. They can:

  • Request the technical documentation and declaration of conformity — you must supply them in a language the authority understands.
  • Require corrective action, restrict or prohibit making the product available, or order a withdrawal or recall.
  • Evaluate products presenting a significant cybersecurity risk and act even where the product is formally compliant.
  • Escalate to a Union-wide measure via the safeguard procedure.

ENISA maintains oversight over the reporting side and can be asked to analyse products.

Penalties

The CRA sets maximum administrative fines:

  • Up to €15 000 000 or 2.5% of total worldwide annual turnover, whichever is higher — for non-compliance with the essential requirements in Annex I and the core manufacturer obligations in Articles 13 and 14.
  • Up to €10 000 000 or 2% — for breaches of other obligations under the regulation.
  • Up to €5 000 000 or 1% — for supplying incorrect, incomplete or misleading information to notified bodies or market surveillance authorities.

The third tier deserves attention: a sloppy or over-optimistic response to an authority's request is separately punishable. Answer precisely, and answer with documents you actually have.

What "ready for a call" looks like

  • The technical documentation is retrievable, per product and per version, within a working day.
  • A named person owns the response and knows where the DoC PDFs live.
  • The Annex I matrix is current, so you can answer a targeted requirement question directly.
  • Support period end dates are published and match the user documentation.

Key takeaways

  • The manufacturer signs the EU declaration of conformity on its sole responsibility; a single DoC covers all applicable acts.
  • CE marking must be visible, legible and indelible, with the notified body number where one was involved.
  • Market surveillance authorities can demand documentation, restrict sales, and order recalls.
  • Fines reach €15m or 2.5% of worldwide turnover; misleading an authority is separately punishable.

References

  • Annex V (EU declaration of conformity)
  • Articles 29-30 (CE marking)
  • Article 64 (penalties)
  • Regulation (EU) 2019/1020

Check your understanding

  1. Q1Who issues the EU declaration of conformity?

  2. Q2The maximum fine for breaching the Annex I essential requirements is:

  3. Q3If a product is covered by both the CRA and the Radio Equipment Directive you should:

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