Ethics committee procedures for the development of medical devices

Ethics committee approval processes in development of medical devices begin with request to obtain CE certificate of medical devices that are classified under the Medical Device Directive. In accordance with the Medical Devices Clinical Research Directive, it is necessary to obtain the approval to test on volunteers with medical devices, which is non-CE marked or similar devices that are not found in international market, from the Turkish Medicines and Medical Devices Agency. In this study, in order to obtain the ethics committee approval from the authorized institution, the required documents on ethics committee submission process have been described in bullets and also explained the contents of these documents by importance. It is intended to be a tutorial guide for medical device developers.