##  [European Authorized Representative (EC REP) Services](/medical-devices/european-authorized-representative-ec-rep-services) 

 

# European Authorized Representatives (EC REP)

For medical device manufacturers without a presence in the European Union (EU), securing a European Authorised Representative (EAR) is mandatory for placing devices on the EU market.

As a **member of the European Association of Authorised Representatives (EAAR)**, Freyr Life Sciences GmbH delivers expertise in navigating EU Regulatory frameworks by streamlining Regulatory requirements and, in turn, ensure compliance with EU regulations.



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- [Overview](#overview)
- [Expertise & Advantage](#expertise)
- [Insights](#insights)







 

## European Authorized Representative (EC REP) Services - Overview



Foreign Medical Device manufacturers who do not have a physical location in Europe must appoint a European Authorized Representative (EAR) based in any member countries of the European Union, who are a part of the countries recognizing CE mark. At Freyr, we offer exceptional European Authorized Representative Services (EC REP) to support our clients at every step in their device registration process.

A European Authorized Representative (EAR) serves as a legal entity designated by non-European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with EU MDR (2017/745) and/or IVDR (2017/746). They act as a point of contact between the non-EU manufacturer and the notified body, as well as national competent authorities.



### In addition, the European Authorized Representative (EC REP) Services include:

- Device registration with national competent authority
- Verify manufacturer’s Declaration of Conformity (DoC), technical documentation and CE Certificate
- Ensuring that an appropriate conformity assessment procedure has been carried out
- Keep available the copy of the Technical File, DoC and CE certificate including the supplements and amendments as applicable
- Communication with the EU competent authorities when required
- Confirming that Technical File Documentation is available for 10 years (Medical Devices) and 15 years (implantable devices) after the last device is placed in the market
- Support in incident and Field Safety Corrective Action (FSCA) reporting
- Represent the non-EU manufacturer in the EU,  has its name and address on product labelling and other Regulatory documents

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## European Authorized Representative 



- [Expertise](#mdv-1)
- [Advantages](#mdv-2)

- Independent representation and Regulatory support
- Continuous liaison with agency for submissions, queries and feedback
- Single point of contact in the country for liaison with Regulatory agency



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- Cost-effective annual support for EC REP services
- Ensured Regulatory expertise outlook
- Qualified team of experts with hands-on experience across all categories of Medical Devices
- Support for region specific Regulatory complexities
- Extensive partner network across the member countries



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