Follow Us:

CE MARKING

Home European Authorized Representative
Contact Us

European Authorized Representative

The European Authorized Representative is legalized and established within the EU and has received and accepted a written mandate or decree from a manufacturer located outside of the European Union. According to EU MDR 2017/745 and IVDR 2017/746, an EU Authorized representative is mandatory for non-European manufacturers wishing to sell medical devices (IVDs) on the European Union market.

EUROPEAN AUTHORIZED REPRESENTATIVE

European Authorized Representative for MDR and IVDR

Under the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the EU Authorized Representative is assigned a narrowly defined role with the belonging obligations.

 

Foreign manufacturers must appoint a European Authorized Representative before they can sell their medical devices and IVDs in Europe. The authorized representative acts as the manufacturer’s regulatory representative in the European Single Market and is the point of contact between the foreign manufacturer and the EU Competent Authorities.

Discover I3CGLOBAL’s European Authorized Representative Services! Navigate EU regulatory compliance effortlessly with our expert guidance. Explore our offerings now

European Authorized Representative Responsibilities

  • Verifying that the manufacturer’s technical documentation file for correct as per guidelines and conformity procedure.
  • Maintaining copies of the technical file. (EAR must maintain documentation for 15 years.)
  • Granting authorization to include the EAR name and address on the device label and DOC
  • Executing an agreement (mandate) with the manufacturer to outline the obligations of both parties throughout the product’s lifespan in the EU market.
  • Apply, review and verify the manufacturer’s EUDAMED Single Registration Number (SRN)
  • Ensure that the manufacturer has fulfilled EUDAMED registration obligations.
  • Provide Competent Authorities with on-request technical documentation.
  • Inform the manufacturer of any complaints from healthcare professionals, users, and patients from the EU territory
  • Support Incident and Field Safety Corrective Action (FSCA) reporting, collaborating with the manufacturer and importers/distributors as necessary.
Do you need an email containing full details within 2 minutes?
Frequently Asked Questions

Is the European Authorized Representative fee annul?

Yes. The EAR service fee is every year. (12 months from the date of appointment)

Does the European Authorized Representative information need to be on the device label?

Under the MDR and IVDR, the European Authorized Representative’s name and address must be on the device label; though not mandatory on the IFU. The technical documentation must contain a specimen of the label and IFU/User manual with EAR name and contact information to demonstrate traceability.

 

To minimize translations, place the EAR information near the EC REP symbol per EN ISO 15223-1:2016. If the label is small, use packaging or IFU. For ‘legacy’ devices under old Directives (MDD, AIMDD, IVDD), EAR info can be on the label, outer packaging, or IFU.

 

The European Authorized Representative information must be detailed in the Declaration of Conformity also.

What about the United Kingdom and Switzerland?

Following the United Kingdom’s withdrawal from the European Union, EU manufacturers must appoint a UK Responsible Person (UKRP) for marketing in the UK. Similarly, due to the lapse of the Mutual Recognition Agreement between Switzerland and the EU for medical devices and IVDs, the EU or UK manufacturers must appoint a Swiss Authorized Representative (CH REP) for marketing in Switzerland.

European Authorized Representative Terms

The MDR 2017/745 and IVDR 2017/746 use the term “authorised representative” in the latest version. The EU Harmonized Standard EN ISO 15223-1 uses the term “authorized representative”, and an “EC REP” symbol is used to indicate the European Authorized Representative. They all mean the same thing.