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 …
Tag: Medical Device Regulations
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 …
Should US MedTech companies be concerned about the new EU Medical Device Regulations?
The EU market has always been attractive for US MedTech companies. Obtaining approval to sell into the EU market has in the past always been easier than getting approval to sell in the US. That may soon change in view of the new EU Medical Device Regulations. For a long time, US manufacturers preferred to Read More …