Preparing for Europe’s Evolving Medical Device Regulation

The Essential Guide to EU MDR Compliance

Section 5: MDR Implementation Checklist

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