EU Representation – (Medical and In Vitro Diagnostic Devices)

International Quality Associates
  • PRRC – EU Regulations for MDR and IVDR require that a Person Responsible for Regulatory Compliance (PRRC) is on staff or on call.   

  • EC REP – If a legal manufacturer (e.g. name and address on label) does not have an address in the EU, then an European Authorized Representative must be appointed, who among other

    • Has a legal presence in the EU  
    • Maintains a copy of your technical documentation
    • Cooperates with EU Competent Authorities
    • Registers your low risk products
    • Is listed on the device labeling
International Quality Associates

State of the Art in Management Systems

Management of Quality shows Quality of Management