Electronic Device Importers The operations of electronic medical device importers also fall under

Electronic Device Importers

The operations of electronic medical device importers also fall under the scope of the RoHS directive as well. Importers are required to ensure that they place only directive-compliant products on the EU market, and that manufacturers of those products have conducted appropriate conformity assessments, prepared required technical documentation and that those products bear CE marking.

Importers also must verify that the manufacturers they represent have properly registered non-conforming products and recalls, and that products they import to the EU have appropriate type, batch or serial numbers. As with labeling requirements for the manufacturer, the importer’s name and contact information should be included on the EEE itself or on its packaging or accompanying documentation.

Reporting and record-keeping requirements for importers under the new directive are significant. In the event that an importer suspects an EEE is not in conformity with the RoHS directive’s Article 4 or other sections, that importer is obligated to keep that EEE from entering the market until any nonconformity issues have been resolved. The importer also must notify both the manufacturer and appropriate market surveillance entities in such instances. Furthermore, importers must register all instances of EEE noncompliance issues and recalls, as well as provide such information to distributors. If suspecting that a nonconforming EEE has made it into the EU market, an importer must either take action to bring that product back into conformity or have it withdrawn or recalled; relevant national competent authorities also should be notified as soon as possible.