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Whitepaper: Is your European medical device importer MDR Compliant?



According to Article 2 (33) of the MDR, the definition of the Importer is “Any natural or legal person established within the Union that places a device from a third country on the Union market”. A product is placed on the market when it is made available for the first time on the Union market.

This means any EU entity obtaining goods direct from a non-EU manufacturer or distributor and places those goods in the Union, will be considered as the MDR importer.

A distributor can be your importer and needs to meet article 13 in addition to article 14 of the MDR. Distributors can be retailers, e-commerce platforms, a pharmacy and other channels. Distributors are not always set-up to comply with the obligations of the importer.

At the end of the day the manufacturer will be held responsible for the entire supply chain, also when the distributor or importer fails to fulfill its obligations. This whitepaper will give guidance on what to consider when you choose to have your distributor become your importer.

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