What the importer must be able to verify

Article 13 of the MDR and IVDR requires importers to check key conformity conditions before placing a device on the market. These include CE marking, the EU declaration of conformity, identification of the manufacturer, designation of the authorised representative where required, compliant labelling and instructions, and UDI assignment where applicable.

Prepare one controlled launch pack

• legal-manufacturer and EC REP details that match the mandate;
• the exact device and model list for the importer;
• the EU declaration of conformity and valid certificate where the route requires one;
• approved labels and instructions for the target Member States;
• UDI and registration data applicable to the launch;
• storage, transport, complaint, vigilance and field-action communication routes;
• change-control rules so the importer does not continue using obsolete documents.

Assign roles before goods move

The manufacturer owns conformity and the technical file. The EC REP performs the tasks defined by Article 11 and the written mandate. The importer verifies the specified conditions and adds its own details as required. A distributor may sit further down the chain. Recording these roles prevents one company from being described inconsistently across the mandate, labels, declaration, EUDAMED and commercial documents.

Do not confuse appointment with readiness

A commercial agreement can be signed early, but the importer must not place a non-conforming device on the market. A responsible launch plan therefore includes a hold point: no release until the controlled conformity and economic-operator pack has been verified.