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How to achieve sustainable reimbursement status in the German out-patient sector Christian Dierks | Managing Partner and Founder of Dierks+Company GTAI at MEDICA 2018 November 12, 2018 2 2 Reimbursement for Medical Devices CE-Marking New


  1. How to achieve sustainable reimbursement status in the German out-patient sector Christian Dierks | Managing Partner and Founder of Dierks+Company GTAI at MEDICA 2018 – November 12, 2018

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  3. Reimbursement for Medical Devices CE-Marking New Method Treatment Method Method Assessment Medical Benefit Medical Necessity Cost Effectiveness Uniform Fee Scale (EBM) 3

  4. Method Assessment Standards of Evidence Based Medicine (ebM) Systematic reviews RCTs Cohort Studies Case Control Studies Case reports Expert opinions 4

  5. Implications: How to New Method Custom-fit trial designs • Established Method Change EBM • Criteria: Mortality, Morbidity, Quality of Life, Reduction of • Adverse Events and side effects (Damage) CONSORT Criteria for Medical Devices? Yes! (in part …) • 5

  6. Questions? Prof. Dr. med. Dr. iur. Christian Dierks Dierks+Company Managing Partner HELIX HUB +49 30 586 930 100 Invalidenstr. 113 christian.dierks@dierks.company D-10115 Berlin www.dierks.company

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