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. But its most important task is to ensure easy access to the European market.
As EC-REP, Llins reviews your Technical Documentation and facilitates obtaining the CE mark.
Llins can act as your Authorized Representative to allow easy access to the European market.
Contact us for more information about our Authorized Representative Services
Appoint Llins as EC-REP
To ensure easy access to the European market, it is important to choose a good Authorized Representative who can guide you through the process.
Our advantages
Regulatory experts
A good EC-REP guides you through the regulations, assists in case of regulatory actions against your company and communicates with the Competent Authorities.
This all requires exquisite regulatory and technical-scientific skills and a fluent communication style. Llins's team has adequate experience and qualities to serve as the ideal Authorized representative.
Independence
As an independent organization, Llins can act as your regulatory guide.