SSInsurance object
Liability insurance or alternative arrangements for damages mandatory for
Investigator(s)
Sponsor
Manufacturer
Study participants
Responsible for covering insurance
Sponsor
Insurance fee: A minimum coverage sum is defined
Yes
Minimum coverage sum
Required compensation sum coverage: • Minimum 250000 € per patient as flat sum or 25000 € per patient/year) • Maximum 2500000 € for the whole study
National legal framework in place
Yes
Additional Information
Insurance mandatory for participants (patients and healthy volunteers) in all clinical investigations of MD (interventional and observational) and for investigators, sponsors and manufacturers in clinical investigations with MD CE-marked use outside label, MD without label, respective combination studies and observational studies.
