SSSponsor object
Sponsor - Definition (pursuant to national law)
The sponsor of a clinical investigation is the party responsible for the device clinical investigation, e.g. the manufacturer, academic group, clinical research organisation.
Manufacturer’s typically act as sponsor for applications made to the CA (if the manufacturer is not based in Europe the name, address telephone fax e-mail address of the authorised representative must be provided)
Principal investigators/clinical investigators may act as sponsor for an investigation but thereby assume all associated responsibility for the clinical investigation.
Co-Sponsor - Definition available in national law
No
Legal representative based in the EU/EEA is mandatory where Sponsor is located outside EU/EEA:
Yes
