--- title: "Who Is the IVDR Sponsor of Your CDx Performance Study?" description: "Who holds IVDR sponsorship in a CDx performance study? Learn why sponsor roles, delegation and governance must be defined early in combined studies." url: https://qbdgroup.com/en/blog/ivdr-sponsor-cdx-performance-study type: "Blog post" language: en published: 2026-09-02 author: "Kirsten Van Garsse" category: "Regulatory Affairs" publisher: "QbD Group" citation: "QbD Group, \"Who Is the IVDR Sponsor of Your CDx Performance Study?\", https://qbdgroup.com/en/blog/ivdr-sponsor-cdx-performance-study" --- # Who Is the IVDR Sponsor of Your CDx Performance Study? > Who holds IVDR sponsorship in a CDx performance study? Learn why sponsor roles, delegation and governance must be defined early in combined studies. **It might not be who you think.** Ask a pharma regulatory team who is running their CDx performance study in Europe, and the answer will almost always be: **us**. Ask the diagnostic partner the same question, and you will hear something similar. Ask the Ethics Committee or Competent Authority, and you may get silence, followed by a question back. This is one of the most common governance failures in combined CDx programmes. It is not dramatic. It does not announce itself early. It surfaces quietly, often months into trial setup, when someone from the authority asks for the IVDR sponsor name and both organisations point at each other. The scenario is real, and it repeats. ## In This Blog Post - Why IVDR sponsorship is easily overlooked in combined CDx studies - How the IVDR sponsor differs from the CTR sponsor and assay manufacturer - What additional requirements apply to sponsors outside the EU - When IVDR sponsorship can be delegated - Why sponsorship needs to be embedded in study governance from the start ## When Nobody Owns IVDR Sponsorship Consider a US biotech expanding into Europe. The company has signed a co-development agreement with a European diagnostic partner. The commercial terms are solid. The milestone schedule is agreed. The CDx development plan is attached. What is missing is a single, formally documented answer to a basic regulatory question: **Who holds IVDR sponsorship for the performance study embedded in this trial?** The pharma team holds the IND and the CTA. They assume they are in charge of the trial. The diagnostic partner understands that its assay is being evaluated, but assumes pharma has the regulatory framework covered. Neither has looked closely enough at the IVDR to realise that the performance study has its own sponsor, with its own legal accountability, separate from the drug trial. That distinction matters. ### What IVDR Sponsorship Actually Means Under the IVDR, a "sponsor" is any individual, company, institution or organisation that takes responsibility for the initiation, management and financing of a performance study (Article 2(57)). It is a broad definition, deliberately so, and one that can easily be met by either party in a co-development arrangement. Crucially, this is **not necessarily the same as the CTR sponsor for the drug trial.** The two roles may overlap. Or they may not. ### Sponsor and Manufacturer Are Not the Same Role Here is the twist many teams miss: **sponsor and manufacturer are not the same role either.** The manufacturer of the assay, the entity that designs and produces it, holds a distinct regulatory position from the sponsor of the performance study. Those responsibilities can sit with entirely different legal entities. A pharma company can be the performance study sponsor for an assay it did not manufacture. A specialist partner can be the sponsor for an assay manufactured by someone else. Assuming that whoever makes the diagnostic is automatically accountable for the performance study is exactly the kind of assumption that produces silence when a reviewer asks the question directly. ## What If the IVDR Sponsor Is Based Outside the EU? For sponsors based outside the European Union, there is an additional requirement: the appointment of an EU legal representative or contact person under IVDR Article 58(4). This representative receives and responds to regulatory communications and acts as a point of contact for Competent Authorities and Ethics Committees. Without the appropriate EU representation in place, the application may be incomplete before it is even submitted. And this is not something that can simply be resolved with a sentence in a co-development agreement. The arrangement requires formal documentation specific to the performance study, clearly establishing the relevant responsibilities and ensuring that the appropriate party is integrated into the governance structure from the start. ## IVDR Sponsorship Can Be Delegated, but Governance Matters Sponsorship delegation under the IVDR can offer a practical solution in combined studies. For example, the pharma company may delegate relevant sponsorship responsibilities to the diagnostic partner or to a specialist third party with an EU presence. That delegation should be formally documented, reviewed by the relevant legal and regulatory teams, and appropriately reflected in the submission. Where things go wrong is when delegation is treated as an administrative hand-off rather than a **governance integration**. The delegated party needs to be in the room for submission planning. They need sight of the performance study protocol. They need to understand: - amendment timelines - safety reporting requirements - monitoring obligations on the device side - regulatory communication pathways - their role within the wider combined-study governance structure If they are brought in only at the point of submission, they are already behind. ## IVDR Sponsorship Is the Foundation of CDx Study Governance Every other governance question in a combined CDx programme, from the submission structure and monitoring plan to the amendment process and safety reporting, depends on a clear, documented answer to one fundamental question: ### Who is responsible for the IVDR performance study? This is not bureaucratic housekeeping. It is the foundation everything else sits on. If you are working on a CDx co-development programme and this question has not been formally answered, the time to address it is now, not when the Ethics Committee asks. --- Source: https://qbdgroup.com/en/blog/ivdr-sponsor-cdx-performance-study — © QbD Group. Quote freely with attribution and a link back.