---
title: "Sponsor Responsibilities in IVD Clinical Performance Studies"
description: "Understand sponsor responsibilities in IVD clinical performance studies across IVDR, applicable FDA requirements (including IDE where relevant), and ISO 20916, including delegation, CRO roles and combined study models."
url: https://qbdgroup.com/en/downloads/sponsor-responsibilities-ivd-performance-studies
type: "White paper"
language: en
published: 2026-03-30
author: "Annelies Rotthier & Kirsten Van Garsse"
category: "Clinical"
publisher: "QbD Group"
citation: "QbD Group, \"Sponsor Responsibilities in IVD Clinical Performance Studies\", https://qbdgroup.com/en/downloads/sponsor-responsibilities-ivd-performance-studies"
---
# Sponsor Responsibilities in IVD Clinical Performance Studies
> Understand sponsor responsibilities in IVD clinical performance studies across IVDR, applicable FDA requirements (including IDE where relevant), and ISO 20916, including delegation, CRO roles and combined study models.

Understand sponsor responsibilities in IVD clinical performance studies under IVDR, FDA IDE and ISO 20916, including delegation, CRO roles and combined study models.

## About this white paper

### Who should sponsor an IVD performance study?

Performance studies generate the clinical evidence needed to support regulatory approval of [in vitro diagnostic devices](/en/industries/in-vitro-diagnostics) and companion diagnostics.

Under both European and U.S. frameworks, the Sponsor carries ultimate responsibility for the scientific validity, ethical conduct and regulatory compliance of the study.

However, the way sponsorship is structured can significantly influence:

- regulatory accountability
- control of clinical evidence
- operational efficiency
- data ownership for regulatory submissions

This white paper clarifies the responsibilities attached to the Sponsor role and provides practical guidance for manufacturers, pharmaceutical partners and CROs involved in IVD performance studies.

## What you'll learn

In this white paper, you'll discover:

- The regulatory responsibilities of Sponsors under EU IVDR, FDA IDE and ISO 20916
- Which activities can be delegated to CROs and which responsibilities cannot
- Key considerations when selecting a CRO for IVD performance studies
- Different sponsorship models in combined drug–diagnostic studies
- Practical strategies to ensure compliant and scientifically robust performance studies

## Download the white paper

Understand the regulatory and operational responsibilities that come with sponsoring an IVD clinical performance study.

Complete the form to access the full white paper and learn how to structure compliant, high-quality performance studies that support successful regulatory submissions.
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Source: https://qbdgroup.com/en/downloads/sponsor-responsibilities-ivd-performance-studies — © QbD Group. Quote freely with attribution and a link back.