Tag: EU Market Entry

MedTech Manufacturers, EU Distribution: Importer and Distributor Agreements (Part 2).

With the new MDR’s coming closer it becomes urgent for companies present in the EU market to sort all matter of distribution issues. The EU distinguishes several levels of economic actors: the Manufacturer, the Authorized Representative, the Importer and the Distributor, and each of these actors is now referred to in the Regulations. In this Read More …

MedTech Manufacturers, EU Distribution: Authorized Representative Agreements (Part 1).

With the new MDR’s coming closer it becomes urgent for companies present on the EU market to sort all matter of distribution issues. The EU distinguishes several levels of Economic Operators: Manufacturer, Authorized Representative (AR), Importer and Distributor. In this first article we will review the role of the Authorized Representative.   The Authorized Representative Read More …