SSInsurance object
Liability insurance or alternative arrangements for damages mandatory for
Investigator(s)
Sponsor
Study participants
Insurance fee: A minimum coverage sum is defined
No
Applicable national legal framework/ Reference
Art 15 & 16 Law 21/2014 (pt)
Art 14, Annex VIII and Annex XVI (15f) DL 145/2009 (pt)
Additional Information
Insurance obligation applies to interventional investigations of MD (MD CE-marked, use within or without label, MD without label, respective combination studies with MP).
