The new European Database on Medical Devices (Eudamed) is the platform to be used for the prospective registration of clinical investigations for medical devices under the Medical Device Regulations. However, Eudamed’s launch has been delayed till 2022. This article discusses the ramifications and the potential solutions for manufacturers to comply with public disclosure expectations and requirements. Until Eudamed is available, posting on other databases is recommended so manufacturers can meet requirements for clinical investigation transparency and disclosure while sharing clinical investigation information necessary to maintain public trust.
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