Representative Services

EC REP Services

EU Authorised Representative (E.A.R) Services

For non-EU manufacturers looking to sell medical devices (MD) and in vitro diagnostic devices (IVD) in the European Union (EU) and European Economic Area (EEA), appointing an EU Authorised Representative (E.A.R) is a legal requirement under the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).

At AQC, we act as your trusted E.A.R, ensuring your products comply with all necessary regulations, facilitating smooth market entry, and representing your company to the relevant EU Competent Authorities.

Our Responsibilities as Your EU Authorised Representative

Regulatory Compliance Support

  • Ensuring your products meet MDR/IVDR
  • Assisting with CE marking and regulatory documentation.

Communication with EU Authorities

  • Acting as the official liaison between your company and EU Competent Authorities for all regulatory matters.
  • Supporting you in responding to inquiries or inspections.

Technical Documentation Review & Storage

  • Reviewing and maintaining a copy of your Technical Documentation, Declarations of Conformity, and post-market surveillance reports.
  • Ensuring compliance with EUDAMED registration requirements.

Incident & Vigilance Reporting

  • Managing post-market surveillance obligations.
  • Reporting serious incidents and safety issues to Competent Authorities as required by law.

Product Labeling & Compliance Checks

  • Ensuring your device labels comply with EU regulatory requirements, including displaying our name and address as your E.A.R.
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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