CJ Managementservice 
•MDR • FDA • ISO 13485 • ISO 9001•  

EU Authorized Representative (EU Rep) 

We Are Your Gateway to the European Market





 Your EU Representative
With Us, the European Market Is Open to You


As your EU Authorized Representative, we open the doors to Europe. 

Manufacturers of medical devices without an establishment in an EU country must appoint an EU Authorized Representative in order to place their products on the EU single market.

With us, you gain direct access to one of the world’s largest healthcare markets

  • Your EU-Agent
  • We act as your Authorized Representative and take over all required responsibilities to ensure your product can be legally placed on the EU market.
  • Your EU-Agent
  • We ensure legal compliance and professional communication with authorities.


Contact Us to Schedule an Appointment or Receive Expert Advice:
📞 +49(0) 170-260-52-47
EU Market Access Made Simple – With CJ Management Service


EU Representative Compact

We Act as Your Authorized Representative 
and
 Take Over All Tasks Required to Place Your Product on the EU Market

EU Authorized Representative-as-a-Service 

On Top, We Provide Additional Helpful Services

Offerings

Description


  • EU Representative Compact

-EU representation agreement
-Registration in EUDAMED (Actor Module)
-Review of technical files
-Contact point for authority inquiries
-All services from EU_Start
-Label & UDI check
-Regular compliance monitoring
-Support with vigilance reporting & recalls
-Annual documentation review & authority communication
-All services from EU_Standard
-Contract drafting & contract review 
-Documentation of all authority contacts & responses



  • EU Authorized Representative-as-a-Service

Selective support with individual EU-REP tasks without assuming the full authorized representative role.
-Audit support (e.g., by notified bodies & authorities)
-EUDAMED UDI management (maintenance of the EUDAMED database)






 
 
 
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