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
Section 6: How Arena Can Help

Sections

Section 1: Introduction

Section 2: Key Changes Under New IVDR

Economic Operator Roles and Responsibilities

Technical Documentation

Performance Evaluations, Performance Studies, and Post-Market Performance Follow-up

Post-Market Surveillance (PMS)

Labeling

European Database for Medical Devices (EUDAMED)

Section 3: Quality Management System (QMS) Requirements

Section 4: Steps For A Successful EU IVDR Implementation

Section 5: IVDR Implementation Checklist

Section 6: How Arena Can Help

Section 7: Appendix - FAQ, IVDR Quick Guide, and References

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