SSInsurance object
Responsible for covering insurance
Sponsor
Additional Information
For clinical investigations that are conducted with medical devices bearing the CE mark, in line with the purpose of use indicated by its manufacturer, the condition for insurance, aimed at securing the volunteers against losses or damages that may arise in connection with the clinical investigation, shall not be sought, with the condition that the ethics committee finds it appropriate based on benefit-risk ratio, however, it is obligatory to arrange insurance for the volunteers in all other medical device clinical investigations (Regulation On Medical Device Clinical Trials 2014).
A comprehensive guideline is available (Guidance on Insurance Coverage for Clinical Trials 2013).
