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Enhancing Medical Device Regulations: Industry Recommendations for Innovation and Safety

Explore industry proposals for improving the regulatory framework of medical devices, emphasizing innovation, safety, and post-marketing surveillance. Recommendations include tighter controls over notified bodies and differentiation between devices and pharmaceuticals.

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Enhancing Medical Device Regulations: Industry Recommendations for Innovation and Safety

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Presentation Transcript

  1. ABHI Presentation to RCS October 2011

  2. MD Regulatory Reform AGENDA • EU Council Conclusions June 2011 • What Needs Improving • Industry Recommendation for New Framework

  3. 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

  4. 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

  5. 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

  6. 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

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