Economic operators (manufacturer, importer, authorised representative, distributor)

Manufacturers are responsible for design, conformity assessment, technical documentation, labelling, and the EU Declaration of Conformity. Importers must verify aspects such as CE marking, documentation, and the inclusion of their name/address; authorised representatives act within the scope of work mandated in writing; distributors ensure correct labelling and accompanying information, and cooperate with public authorities.

In practice, a role and obligation matrix should be maintained for each product line, also covering special cases such as distance selling, fulfilment service providers, and non-EU manufacturers with EU-authorised representatives. Clear processes for corrective action and reporting obligations mitigate risks during inspections and audits.