2800 Patton Road | Roseville, MN 55113

EU IVDR Consulting

In Vitro Diagnostic Regulation (IVDR) has changed, is your company prepared?

IVD medical device manufacturers are now required to provide documentation for regulatory approval through EU Notified Bodies and gain CE Mark certification. IVDR regulation enforcement will begin on May 26, 2020.

Fang Consulting is prepared to provide regulatory strategy and consulting services to meet the new EU IVDR requirements. Our experts will educate your team on why and how the new regulations may impact your medical device products. We understand how the new IVDR requirements involve both technical documentation and post-market surveillance of medical devices in order to gain regulatory submissions compliance. The Fang Consulting team is equipped with the knowledge to advise and spearhead your EU IVDR regulatory projects to uphold all changing requirements.

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Our EU IVDR Services

Impact Assessment

  • Medical device classification review
    • New rule-based risk classification compared to current EU IVDR list-based classification
  • New/updated required documentation
    • Performance evaluation plans and reports
    • Post-market surveillance of medical devices plans and reports

Technical Documentation Gap Assessment

  • EU IVDR provides more specifics of what needs to be included in Technical Documentation

QMS System Gap Assessment

  • EU IVDR provides more specifics of what needs to be included in a manufacturer’s certified quality management system (QMS)

Notified Body Submissions/Reviews

  • All medical devices require Technical Documentation, UDI, and post-market surveillance
  • Notified Body conformity assessments required for most classes of devices

New EU IVDR Requirements, We Will Make Sure You're Prepared