General Obligations of Importers under EU MDR

[Roland chung]

Hi all,
MDR Article 13 sets out the importer's general obligations. In order to achieve, for example, verification of the labelling, does each shipment have to reach the importer?

Thanks,
Roland

 

[Ronen E]

In order to achieve, for example, verification of the labelling, does each shipment have to reach the importer?

Article 13 and the guidance I'm aware of do not specify how to verify the labelling. If the importer can achieve it otherwise, I think they don't have an obligation to do it on/in their their own premises.
Also see MDCG 2021-27.

 

[Roland chung]

Agreed, there is no specific requirement, where or how to fulfill the obligations.

 

[goldenguo]

MDR or IVDR did not require the shippments reach to importer.
They can verify labelling very easy by ask manufacture email them a photo.