SSSponsor object

Sponsor - Definition available in national law

Yes

Sponsor - Definition (pursuant to national law)

Sponsor of the clinical investigation (pursuant to Section 13 of Act No 268/2014 Coll. on Medical Devices):
'the person who orders the conduct of the clinical investigation from a provider of healthcare services, and who safeguards the commencement, management, organisation, control, and, where applicable, financing of the clinical investigation. The sponsor of the clinical investigation shall be established within the territory of a Member State or shall grant the power of attorney to a person established within the territory of a Member State'

Sponsorship mandatory

Yes

Sponsorship mandatory - Additional information

It is mandatory to have a sponsor in interventional investigations on MD (CE-marked, used within or outside label + non-CE-marked devices + respective combination studies with MP) and observational investigations on MD.

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

Additional Information

Obligations of the sponsor of a clinical investigation are specified in Section 19 of Act No 268/2014 Coll. on Medical Devices.

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
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