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