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EC REP / Authorized representative for a medical device manufacturer established outside the Union

​EC REP / Authorized representative for manufacturers of medical devices in accordance with Regulation 745/2017 on medical devices

EC Rep - Authorized Representative MDR IVDR

Who needs an authorized representative according to EU MDR or EU IVDR?

According to the EU MDR, all medical device manufacturers who are based outside the EU member states and want to sell their medical devices in the EU require an EU authorized representative.

 

Likewise, according to the EU IVDR, manufacturers of in-vitro diagnostics (IVD) products that are based outside of the EU member states require an EU authorized representative in order to be able to sell their products in the EU.

What are the tasks of an EU authorized representative?

  • Storage of the technical documentation for the medical devices

  • Providing technical documentation to state authorities upon request

  • Forwarding reports of defects in medical devices to authorities

  • Function as contact person established in the Union

  • Monitoring regulatory compliance

  • Providing a Regulatory Compliance Person (PRRC)

  • Immediate notification of complaints to the manufacturer

  • Termination of the mandate if the manufacturer violates its obligations under the EU MDR Regulation

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