Authorized Representative (EC-REP)

Are you looking for an Authorized Representative (EC-REP) for your medical devices and/or IVDs? 

Qarad – part of the QbD Group – is an independent partner that can act as your Authorized Representative (EC-REP). 

Find out more about our EC-REP service below. 

Authorized Representative (EC-REP) - Quality by Design

Part of the QbD Group

This service is supported by Qarad

What is an EC-REP?

KEY TO PLACING YOUR DEVICE ON THE EUROPEAN MARKET

Medical devices and/or IVD manufacturers 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 (EC-REP) in order to comply with the Directives and Regulations.

The exact roles and responsibilities of the Authorized Representative are described in several places of the European Directives and Regulations. The 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.

 

Why QbD Group?

OVER 20 YEARS OF EXPERIENCE IN MD & IVD

To ensure easy access to the European market, it is important to choose a good Authorized Representative who can guide you through the process.

Qarad – part of the QbD Group – is a member of the European Association of Authorized Representatives (EAAR). We offer high-standard services and work according to EAAR’s Code of Conduct.

We build on the regulatory and technical competence of our expert team, can act as an independent EC-REP, and keep your regulatory interests separate from your supply chain. 

Our experts can familiarize you with local regulations, assist you with regulatory actions against your company, and communicate with the appropriate authorities.

Qarad also offers you 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 guide on regulatory matters.

We have acted as a European Authorized Representative for over one hundred different companies during the many years that we have been in service. Our assistance guarantees easy access to the European market.

Authorized Representative (EC-REP) - Quality by Design

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Contact us for more information or request a free, no-obligation proposal.