EC-REP - Regulatory Affairs - QbD Group (1)

Authorized Representative (EC-REP)

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

QbD Group, supported by the Qarad experts, is an independent partner that can act as your Authorized Representative (EC-REP).

Find out more about our EC-REP service below.

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/ EEA 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, QbD Group reviews your Technical Documentation and facilitates obtaining the CE mark.

How can we support you?

OVER 20 YEARS OF EXPERIENCE IN MD & IVD

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.

What we offer

Regulatory expertise:
- Extensive technical and regulatory competence to support your compliance needs.
- Independent representation to keep your regulatory and supply chain interests separate.
Comprehensive support:
- Familiarization with local regulations to ensure compliance.
- Assistance in managing regulatory actions taken against your company.
- Direct communication with European authorities on your behalf.
Independence and objectivity:
- We offer impartial EC-REP services, avoiding conflicts of interest associated with appointing a distributor.
- Your regulatory interests remain fully independent from your commercial operations.

Proven track record

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.