SSInsurance object
Liability insurance or alternative arrangements for damages mandatory for
Manufacturer
Study participants
Insurance fee: A minimum coverage sum is defined
Yes
Minimum coverage sum
500,000 EURO per person
Additional Information
Insurance for participants (patients and healthy volunteers) is mandatory in interventional studies of MDs (MDs with CE-mark, use within or outside label, MDs without CE-mark, respective combination products with IMP) and must be commensurate with the risks associated with the clinical study.
It must be concluded, on the basis of the risk assessment, in such a way that in case of death or permanent disablement of a participant in a clinical trial, it provides a minimum coverage sum.
No mandatory insurance for investigators and sponsors; Insurance for manufacturers is only mandatory for studies with MD NOT bearing CE-mark
