Roles and responsibilities of the EC-REP
Manufacturers of In Vitro Diagnostics, Medical Devices and Active Implantable Medical Devices who do not have a registered place of business in a Member State of the EU or EFTA, nor in Switzerland or Turkey, need to appoint an Authorized Representative or EC-REP.
Qarad can act as your EC-REP to facilitate your product's access on the European market.
The exact roles and responsibilities of an Authorized Representative are clearly defined in the different Directives and Regulations.