Clinical & Trials
Performance Study (IVDR)
In one line
A study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77.
Definition
Article 2(42) of the IVDR defines a performance study as a study undertaken to establish or confirm the analytical or clinical performance of a device. Articles 57 to 77 and Annex XIII Part A Section 2 set out study design, sponsor obligations, ethics review, informed consent, and adverse-event reporting, with additional obligations for interventional studies and studies involving companion diagnostics.
Why it matters
Performance studies are the IVDR analogue of MDR clinical investigations but with categories tied to invasiveness of sampling and use of results in patient management. Interventional studies (Article 58(2)) require prior authorisation by Member States, similar to MDR clinical investigations.
Common pitfalls
- •Assuming every performance study follows the same authorisation pathway. Requirements depend on features such as invasive sampling, additional procedures, and use of results in patient management.
- •Treating analytical performance alone as proof of clinical performance. Demonstrating reliable measurement does not necessarily establish how results relate to a clinical condition in the intended population.
- •Treating MDR clinical investigation requirements or FDA clinical trial information as substitutes for IVDR requirements. An IVD performance study needs an assessment against the applicable IVDR provisions.
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