SSInsurance object

Liability insurance or alternative arrangements for damages mandatory for

Study participants

Responsible for covering insurance

Legal representative domiciled in the EU/EEA

Insurance fee: A minimum coverage sum is defined


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.