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All readiness checks

Readiness for CE Marking

Assess whether your product is ready for CE marking and for placing on the EEA market.

16 questions · ~4 min

Anonymous: we don't ask for a name, email or company details. Only the answers are kept, with nothing that identifies you, for statistics.

How to answer

Choose “Yes” only when the requirement is applied in practice and there is documentation or records. “Partly” means it is done informally or not everywhere.

Applicable legislation

Have you identified all the EU directives and regulations that apply to the product (e.g. machinery, low voltage, electromagnetic compatibility, RoHS, construction products)?

Have you identified the harmonised standards or other technical specifications you will apply?

Have you determined your role (manufacturer, importer, distributor, authorised representative) and the obligations that come with it?

Essential requirements and risks

Has a risk assessment of the product been carried out and documented?

Has compliance with each essential health, safety and environmental requirement been checked against a checklist?

Conformity assessment

Have you identified the conformity assessment procedure (module) and whether a notified body is required?

Have the required tests or calculations been carried out, and are there test reports?

Has a notified body been involved, and are the relevant certificates available? If this does not apply to you, choose “Not applicable”.

Technical file and declaration

Is there a complete technical file (description, drawings, risk assessment, standards, test reports, instructions)?

Has an EU Declaration of Conformity been drawn up and signed?

Are the file and the declaration kept for the period set by the legislation (usually 10 years after placing on the market)?

Marking and information

Is the CE marking affixed correctly (visible, legible, indelible, with the notified body's number where required)?

Are there product identification, manufacturer details, instructions for use and safety information in the language of the country where the product is sold?

Production and the market

Is there production control ensuring that every product conforms to the type that was assessed?

Do you monitor changes to the product, the legislation and the standards that may require a new assessment?

Is there a procedure for complaints, nonconforming products, recalls and informing the authorities?

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