SSInsurance object
Liability insurance or alternative arrangements for damages mandatory for
Investigator(s)
Study participants
Responsible for covering insurance
Sponsor
Legal representative domiciled in the EU/EEA
Insurance fee: A minimum coverage sum is defined
No
Minimum coverage sum
Adequacy assessed by ethics committee.
Additional Information
For studies of marketed devices and in vitro diagnostics and used within CE marking an investigator insurance is sufficient, if no additional diagnostic or therapeutic interventions are planned.
The sponsor is obliged to cover all damage.
