Sponsor

The sponsor holds legal responsibility for the study even when much of the work is outsourced to a contract research organization. Under the MDR, a sponsor based outside the EU needs a legal representative in the EU.

‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation;

EU MDR, Article 2(49)

‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the performance study;

IVDR, Article 2(57)

Sponsor means “applicant” (see § 3.2(c)).

21 CFR, 3.2

Sponsor means a person who initiates a clinical investigation, but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to or used involving, a subject under the immediate direction of another individual. A person other than an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators.

21 CFR, 50.3

Sponsor means a person or other entity that initiates a clinical investigation, but that does not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual. A person other than an individual (e.g., a corporation or agency) that uses one or more of its own employees to conduct an investigation that it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators.

21 CFR, 56.102

Sponsor means a person who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.

21 CFR, 812.3

individual, company, institution, or organization taking responsibility and liability for the initiation and management of a clinical investigation (3.8), and arranging the financial setup Note 1 to entry: When an investigator (3.30) initiates, implements, and takes full responsibility for the clinical investigation, the investigator also assumes the role of the sponsor and is identified as the sponsor-investigator.

ISO 14155:2020, clause 3.49

The MDR and IVDR focus on taking responsibility for initiating, managing and setting up the financing of a clinical investigation or performance study. The 21 CFR definitions describe a sponsor as one who initiates but does not personally conduct the investigation, and treat a company that uses its own employees as investigators as a sponsor, not a sponsor-investigator. 21 CFR 3.2 equates sponsor with applicant.