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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 this means in practice

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

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    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.