Eu authorized representative

EU Authorized Representative service 

Your pathway to the European Union
medical device market

The EU MDR (2017/745) and and EU IVDR (2017/746) state that, regardless of the device class, to place a device into the EU market, a manufacturer established outside the EU, is required to have an EU Authorized Representative. The representative must be located within the European Union and is designated with a mandate.  

EU Authorized Representative service by MDBS 


Fineltec's Medical Device Business Solutions (MDBS) offers EU Authorized Representative service for non-EU medical device manufacturers, who want to access the European market. 

 MDBS will guide you through the process of EU Authorized Representative designation. Once the service is up and running, MDBS will carry out all the EU Authorized Representative duties for you as required in EU MDR (2017/745) and EU IVDR (2017/746). 

Post-Market Surveillance Eudamed

The mandate 

EU MDR (2017/745) and EU IVDR (2017/746) require that the EU Authorized Representative designation is made in the form of a mandate. This mandate is to be understood as a power of attorney by which the manufacturer gives another legal entity the authority to perform specific tasks for them.   

The mandate 

  • Shall be done in writing  
  • Shall be accepted by both parties  
  • Shall provide a sole authorized representative for a device 
  • Shall cover all devices of the same device group  
  • Shall specify the list of authorized representative tasks 
  • Shall not delegate any of the manufacturer’s obligations to the authorised representative

Conditions for the Designation

EU MDR (2017/745) and EU IVDR (2017/746) set number of conditions for the Manufacturer and for the EU Authorized Representative. 

In summary, for all device classes, the Manufacturer must 

  • Be established outside the EU 
  • Have a drawn-up EU Declaration of Conformity 
  • Have compiled technical documentation 
  • Have a quality management system 

 Whereas the EU Authorized Representative must 

  • Be established within the EU 
  • Have a person responsible for regulatory compliance (PRRC) permanently and continuously at disposal  
  • Ensure that the PRRC possesses the requisite expertise 

EU Authorized Representative

€ 199 per Month
  • Designated EU Authorised Representative
  • EUDAMED Registrations
  • Single Registration Number (SRN)
  • Competent Authority Liaison
  • EU Mailbox and Address
  • Vigilance*
  • CAPA*

Get started

Our mission is to provide high quality services with a personal touch. We cooperate closely with our customers, helping them to grow together with a reliable partner. We understand our customers’ needs and assist them to be one step ahead on the fast-moving market.  

ISO Certification
  • Established in 1993 
  • Nearly 100 employees 
  • Production facility of 4000 m2 
  • 17 million Euro turnover 
  • EU location 

Our clients include

MDBS Clients