1. Report on WG Clinical Investigation and Evaluation (CIE) Wolfgang Ecker Fed. Min. of Health, Austria Chairman CIE Cracow, 28-10-2011

2. CIE Work Plan - Achievements Help develop regulatory system: Contributions to WG Recast wish list; options paper Develop guidance: MEDDEV SAE-Reporting + summary tab form MEDDEV PMCF-studies in final stage (GHTF) Individual SAE-reporting form in prep (GHTF) EUDAMED CI module in operation: Yes and constantly improving Unique identifier Electronic CI notification form for easier upload in prep

3. CIE Work Plan - Targets Mirror group of SG 5: Last GHTF Guidance to transpose > PMCF-studies Contributions to SG1/SG5 TF on Clinical Evaluation of IVDs Contributions to SG2/SG5 TF on SAE-Reporting (esp individual SAE-reporting form) Exchange of opinions/experiences/best practice: Regularly done at CA-only sessions CIE homepage: Yes, but it‘s not so easy to find us! CIE Work Plan - Achievements

5. CIE Work Plan - Targets Support Recast: Ready to help with specific drafting tasks Ressource sharing/VHP/CAP: pilots to be planned for recast VHP/CAP? Administrative Cooperation Forum for discussing critical issues in multinational trials Develop best practice guidance Surveillance program: Implementation of 2007/47/EC in practice? MF/NB? Program development together with COEN and NBOG CIE Next Steps

6. CIE Work Plan - Targets Cooperation with Clinical societies, Registers, Pharma, HTA, Patients organizations, other stakeholders: First steps (Orthopedics, Registers, Pharma [COM, HMA/CAMD], HTA) done Define modalities and areas of cooperation Intensify contacts and cooperation Increase transparency and active PR Training, e-learning: First trial 2012? CIE Next Steps

7. Thank You!