Distributors help ensure that only products compliant with EU legislation and bearing the CE marking are placed on the extended Single Market of the EEA. As they are the intermediaries between manufacturers and traders, they must have overall knowledge of the legal requirements and make sure that the products they distribute or import meet them.

Distributors must handle the product carefully and they mustn’t affect its compliance with EU legislation. The distributor has to know which products must bear the CE marking and the accompanying documentation. They should be able to identify products that are not in compliance.

Distributors must be able to demonstrate to national authorities that they:

• have confirmation from the manufacturer or the importer that the necessary measures have been taken are able to assist national authorities in their efforts to receive the required documentation
• If distributors market the products under their own names, they take over the manufacturer’s responsibilities. In this case, they must have sufficient information on the design and production of the product because they will be assuming the legal responsibility when affixing the CE marking.

We help medical product manufacturers research, analyze, select and manage medical distributors.

Whether you are entering a new market or expanding your distribution network, we can assist you with selecting high quality medical distributors. With a team of experienced professionals we help you make the right choices, and work to promote long term relationships between you and your distribution partners.

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