SSSponsor object
Sponsor - Definition available in national law
Yes
Sponsor - Definition (pursuant to national law)
Definition of sponsor pursuant to Art 2 (28) Medical Device Act 2010:
“Any entity responsible for initiating and conducting a clinical investigation having the place of residence or the registered office in a Member State or acting solely through the agency of its legal representative having the place of residence or the registered office in a Member State”.
Definition of Authorised representative: see Art 2 (2) Medical Device Act 2010.
Sponsorship mandatory
Yes
Co-Sponsor - Definition available in national law
No
Co-sponsorship allowed
No
Legal representative based in the EU/EEA is mandatory where Sponsor is located outside EU/EEA:
Yes
