Preparing for Europe’s New In Vitro Diagnostic Medical Device Regulation

The Essential Guide to EU IVDR Compliance

Section 5: IVDR Implementation Checklist

  • Be Compliant With Required RegulationsEstablish an IVDR transition team
  • Confirm medical device classifications under IVDR
  • Contact notified body to confirm scope of designation and timeline for assessment
  • Develop IVDR transition plan, budget, and timeline
  • Designate “person responsible for regulatory compliance”
  • Develop a risk management plan
  • Prepare plans for performance evaluation, post-market performance follow-up (PMPF), and post-market surveillance
  • Update QMS, technical file, and device labeling per IVDR requirements
  • Conduct company-wide training on new IVDR and QMS
  • Conduct internal audit to verify that all requirements are met