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ABHI Presentation to RCS. October 2011. MD Regulatory Reform. AGENDA EU Council Conclusions June 2011 What Needs Improving Industry Recommendation for New Framework. MD Regulatory Reform. EU Council Conclusions Innovation and the role of SME’s

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abhi presentation to rcs
md regulatory reform
MD Regulatory Reform

AGENDA

  • EU Council Conclusions June 2011
  • What Needs Improving
  • Industry Recommendation for New Framework
md regulatory reform1
MD Regulatory Reform

EU Council Conclusions

  • Innovation and the role of SME’s
  • Innovation that is safe, effective and timely
  • Further Development of Post-Marketing Surveillance and Vigilance
  • Transparency
  • Tighter Controls over Notified Bodies
md regulatory reform2
MD Regulatory Reform

Industry Recommendations

  • Current system has brought safe and innovative products to patients
  • Regulation needs to differentiate between devices and pharmaceuticals
  • Design Controls for Engineering Technologies
  • Previous successes; Orthopaedics, Stents, Cardiac Catheters
md regulatory reform3
MD Regulatory Reform

Improvements (1)

  • Notified Bodies
    • Designation and Control
    • Enhanced Accreditation Procedures
    • Training and Monitoring
  • PMS and Vigilance
    • Criteria for reporting, timelines and coordination
    • Central Reporting
    • Coordination between Authorities
md regulatory reform4
MD Regulatory Reform

Improvements (2)

  • Novel Technologies
    • New structures must not stifle innovation
    • Design Management
    • Scientific Support with clear direction
  • Transparency
    • Patient and citizen en-powerment
    • Use of Information Technology
    • Data basing