Medical Device Injuries

Insurance for Covering Medical Device Injuries

The manufacturer, or authorized representative, of a device which is intended for clinical trials must provide a written confirmation stating that the said device conforms to the essential requirements with the exception of the issues that are the focus of the study and all necessary measures have been taken in view of these issues to protect the health and safety of patients.In addition to the above mentioned confirmation concerning the medical device, the manufacturer or the sponsor responsible for conducting the device trial, must confirm the validity of the study subjects insurance to cover all injuries related to the investigational medical device.