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    Authorized Representative (EU)

    Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    The Authorized Representative is mandated by a written contract, registered in EUDAMED, and shares specific liabilities with the manufacturer. They hold technical documentation, interface with competent authorities, and handle vigilance reports.
    What the regulation says
    The Authorized Representative, as defined in EU MDR (Regulation (EU) 2017/745) Article 11, acts on behalf of a manufacturer not established in the European Union. They ensure compliance with the MDR and serve as a contact point for competent authorities. Their duties are further elaborated in Article 11 and Annex V of the MDR, including verifying the declaration of conformity and technical documentation.

    What this means in practice

    Choosing a competent EC REP with strong notified-body and competent-authority relationships is a strategic - not just administrative - decision.

    Examples

    • A US-based MedTech manufacturer appoints a German Authorized Representative to place their Class IIa surgical device on the EU market.
    • An EU competent authority contacts the Authorized Representative of a Japanese medical device company to request clarification on a vigilance report.
    • A manufacturer updates their technical documentation in response to a notified body audit, and the Authorized Representative ensures they have the latest version.
    Common pitfalls
    • •Misunderstanding the Authorized Representative as a mere postal address, rather than a key regulatory actor with legally defined responsibilities.
    • •Failing to provide the Authorized Representative with full access to technical documentation, hindering their ability to perform required checks.
    • •Assuming the Authorized Representative bears sole liability, whereas liability is shared with the manufacturer for non-compliance.
    • •Not establishing a clear, written mandate with defined responsibilities, as required by EU MDR Article 11(3).

    Frequently asked questions

    The primary role is to act as a liaison between the manufacturer not based in the EU and the European competent authorities, ensuring the manufacturer's compliance with the EU MDR.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    EUR-Lex·1IMDRF·1RAPS·1
    1. 1
      MDR Article 11
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      IMDRF Documents
      Verified
      IMDRFimdrf.org
    3. 3
      RAPS Regulatory Focus
      Verified
      RAPSraps.org

    Inline markers like [1] jump to the matching reference above.