Journal of diabetes science and technology
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J Diabetes Sci Technol · Mar 2013
Considerations for an institution for evaluation of diabetes technology devices to improve their quality in the European Union.
All medical devices used for self-monitoring of blood glucose (BG), insulin injection, continuous subcutaneous insulin infusion, and continuous glucose monitoring in the European Union (EU) must have a Communauté Européenne (CE) mark. However, the approval process for obtaining this mark is different from that used by the European Medicines Agency in the EU for drugs or by the Food and Drug Administration in the United States for such medical and in vitro diagnostic devices. The notified bodies involved in the CE mark process perform this evaluation in cooperation with the manufacturers. ⋯ The work of such an institution would focus on BG test systems (these represent two-thirds of the market of medical devices for diabetes treatment) but would also evaluate the performance of other devices. It has to be clarified what legal framework is required for such an institution and how it can be financed; probably this can be done in a shared manner by the manufacturers of such devices and the health insurance companies. Positive evaluation results should be a prerequisite prior to any reimbursement for such devices.