EC-REP services

If you want to sell your product in other countries than your own, it is important to take into account the local regulations. Many countries require
so-called “third country manufacturers” to appoint an Authorised Representative before they can sell their products in the respective country.

caution2

Caution

Beware of fraudulent Declarations of Notification issued in our company name! Please verify the authenticity of the Declaration of Notification issued by Qarad which you have received from your supplier.

Please contact: ECREP@qarad.com

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

Qarad can act as your Authorized Representative to allow easy access to the European market.

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.

Appoint Qarad 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.

After comparison of many EU representatives, I found QARAD was more professional with rich regulatory and technical-scientific skills. There's no doubt QARAD will be the first choice.

Serena Gao - Amoy Diagnostics Co. Ltd.

Our advantages

EAAR member

Qarad is a member of the European Association of Authorized Representatives.

We offer high standard services and work according to EAAR’s Code of Conduct.

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. Qarad’s team has adequate experience and qualities to serve as the ideal Authorized representative.

Independence

To separate your commercial and regulatory interests in Europe, it is not a good idea to appoint a distributor as EC-REP.

As an independent organization, Qarad can act as your regulatory guide.

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