How should companies respond to an EU market surveillance documentation request?
Start by matching the request to the product, model, batch, software or firmware version, sales channel, and EU market where the authority is asking. Then identify the relevant economic operator: the EU manufacturer, importer, authorised representative with a written mandate, or, where no such operator is established in the Union for the handled product, the EU fulfilment service provider.
For products covered by Article 4, the operator must verify that the declaration and technical documentation have been drawn up when the applicable Union harmonisation law requires them. It must keep the declaration or declaration of performance available for the period required by that law and ensure the technical documentation can be made available to the authority on request.
Treat the authority request as a controlled response record. Provide the documents specifically requested, in a language the authority can easily understand, and keep a log of what was sent, what was withheld as not applicable, who approved the response, and any corrective action promised or completed.
- Confirm the authority, legal basis, product identifiers, units or listings in scope, and requested documents before assembling the pack.
- Include the EU DoC or declaration of performance where required, the technical documentation index or access route, test reports or certificates relied on, responsible-operator contact details, and supply-chain evidence showing who can obtain missing records.
- If the product may present a risk or the file shows non-compliance, record the market-surveillance notification, corrective-action owner, withdrawal/recall or mitigation decision, and follow-up evidence.
Article 4 sets the EU-established operator tasks for declarations, technical documentation, authority requests, risk notice, and corrective-action cooperation; Articles 7 and 14 support cooperation and document-request powers.
Commission guidance explains how to identify the Article 4 economic operator, arrange access to declarations and technical documentation, and handle authority contacts in practice.
Commission overview links Article 4 to information sharing, cooperation with market surveillance authorities, and the need for a designated EU representative for certain sellers.
Blue Guide guidance supports the DoC, manufacturer responsibility, importer checks, and importer access to the technical documentation needed for national authorities.