SSInsurance object

Liability insurance or alternative arrangements for damages mandatory for

Investigator(s)
Manufacturer
Study participants

Responsible for covering insurance

Sponsor
Manufacturer acting as sponsor

Applicable national legal framework/ Reference

Article 13(3) Medical Devices Decree (Dutch)
Insurance Decree (Verzekeringsbesluit) - 1th of July 2015

Additional Information

The manufacturer must have a valid liability insurance to cover any harm caused by the clinical investigation (pursuant to Article 13(3) Medical Devices Decree (Dutch))

The adapted Insurance Decree (Verzekeringsbesluit) came into force as of the 1th of July and applies to reserach issued a positive decision by an accredited MREC or the CCMO after the 1st of July 2015.
The Insurance Decree contains the rules for the obliged insurance for research subjects.

Related details are provided on the CCMO website in section:
Home>Investigators>Standard research file (G. Insurance information) and Home>News archive>Consequences of the new Insurance Decree and CCMO Directive External Review as of 1st July 2015

Amongst the changes is the new rule that the sponsor ensures that any potential damages for all participating human subjects of a research are covered and research subjects who participate in multicentre research in the Netherlands must be covered by a single research subject insurance. Research applicants are also required to submit a Research subject insurance declaration.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395