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