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 Innovation that is safe, effective and timely Further Development of Post-Marketing Surveillance and Vigilance Transparency Tighter Controls over Notified Bodies

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 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 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