Selling medical devices from USA in EU markets

[lennsy]

Hello everyone,

I would like to ask you for your support regarding the possibility selling the medical devices from the USA manufacturer on the European markets in the role of importer. Are there any requirements / notification process which should be fulfilled generally or it is limited to the regulatory and registration reqiurements of this particular European country where the device will be distributed? Should this European company be registered as Importer in EUDAMED?

 

[EmiliaBedelia]

You need to look at Article 13 of the MDR. This details the responsibilities of the importer. Note that importers may only distribute products that are in compliance with the regulation. The manufacturer will have the bulk of the responsibility for compliance to the regulations (Article 10) but the importer has their own responsibilities as well. The manufacturer will also need an authorized representative based in the EU - could be the importer but does not have to be. The AR has their own responsibilities defined in Article 11. No one is off the hook now under MDR

Importers, authorized representatives, and manufacturers are all required to register in EUDAMED.