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

European Authorized Representative (EU-REP)

For medical devices and in vitro diagnostics devices, it’s a legal requirement under EU Regulations (MDR and IVDR) to appoint an EU Authorized Representative based within the EU to ensure and maintain compliance of these devices and serve as a main point of contact in the EU.

What is an European Authorized Representative?

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 (EU-REP) in order to comply with the Directives and Regulations.

Based in Belgium, within the European Union (EU), and a proud member of the European Association of Authorized Representatives (EAAR), the QbD Group is fully qualified to serve as an authorized representative for non-EU manufacturers seeking seamless access to the European market.
Our experienced team of regulatory experts ensures efficient communication and collaboration with European authorities, while effectively carrying out all required tasks in strict accordance with official regulatory guidelines.

Our support

Our Role as EU Authorized Representative

Verify your EU Declaration of Conformity & technical documentation and completion of the required conformity assessment procedures
Store technical documentation, EU Declaration of Conformity & Notified Body certificates (min. 10 years)
Ensure registration in accordance with IVDR and confirm obligations under Articles 24, 26, and 28
Provide documentation to EU authorities upon request
Forward and fulfill authority requests for samples or device access
Coordinate corrective/preventive actions with authorities
Alert you to any product-related complaints or incidents

EC-REP - Regulatory Affairs - QbD Group (2)

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European Authorized Representative (EU-REP)

What is an European Authorized Representative?

Our Role as EU Authorized Representative

Why partner with QbD Group?

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