SSInsurance object

Responsible for covering insurance

Sponsor

Applicable national legal framework/ Reference

Section 14(2) & 19(2) of Act No 268/2014 Coll. on Medical Devices

Additional Information

Insurance must cover any damage, injury to health or death, effective throughout the conduct of the clinical investigation including cases when it is not possible to evidence the fault of a specific person; the scope of insurance shall be adequate to the risks associated with the conducted clinical investigation

Feedback