Jakub Milcarski
Starting to get Involved
A manufacturer outside EU produces a single medical device. He has designated an ECREP. How many importers can he have? According to the definition of the MDR an importer is the one who places first the product on the EU market. Is this per EU country or for all EU countries?
For example if a company places the product first on the market of Germany and then another company places the product first in the market of Italy, are these 2 companies considered importers? Or importer is considered only the one that placed the product on Germany (fisrt placement in EU)?
For example if a company places the product first on the market of Germany and then another company places the product first in the market of Italy, are these 2 companies considered importers? Or importer is considered only the one that placed the product on Germany (fisrt placement in EU)?