Authorized Representative Services
To comply to the Directives and Regulations, manufacturers need to appoint an Authorized Representative (or EC-REP) if they meet the following conditions:
- The manufacturer does not have a registered place of business in a Member State of the EU or EFTA, nor in Switzerland or Turkey.
- They are manufacturing:
- In vitro diagnostic medical devices (all classes)
- Medical devices (all classes)
- Active implantable medical devices
Role of the Authorized Representative
The exact roles and responsibilities of the Authorized Representative are described in several places of the European Directives and Regulations (Click here for an overview). But its most important task is to ensure easy access to the European market.
As EC-REP, Qarad reviews your Technical Documentation and facilitates obtaining the CE mark.
