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Medical Distributors as Your EU MDR-IVDR Importer

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Emre Aykac
Medical Distributors as Your EU MDR-IVDR Importer

An EU distributor (or any retail channel) who directly obtains the goods from a non-EU manufacturer or distributor, clears it from customs and places that product in the Union, will automatically receive the responsibilities of an importer. Meaning that in this case the distributor becomes the MDR importer. If they purchase it from a wholesaler or another EU based distributor, they will be considered as the distributor. In Article 14 / MDR the obligations of the distributor are stated, and in this case the distributor also needs to comply with Article 13 which will make the distributor jointly liable for goods placed on the market. The complications of designating a distributor as the importer is described below


A manufacturer can also appoint multiple distributors or importers. There is no limitation to the number of importers as long as article 13 of each importer is fulfilled. It is not possible to have multiple distributors for an individual device. Designating multiple importers also means more challenges, lack of insights in traceability and market complications as described in the section below:


If the manufacturer has a subsidiary as an entity in the Union and supplies the goods directly to the end-user, the manufacturer can also act as the importer. If you as a non-EU manufacturer want to sell directly into the Union to a patient, healthcare professional or hospital, your end-user cannot be your importer. So if you are intending to sell directly into the market you would need to appoint an importer.


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Emre Aykac
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