All terms
Performance Study (IVDR)
A study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026
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.What this means in practice
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.Related terms
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· Hand-selected related conceptsMore in Clinical & Trials
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Adaptive Trial Design
Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Clinical & Trials
Adverse Event(AE)
Any untoward medical occurrence in a subject, whether or not related to the device.
Clinical & Trials
ALCOA+
Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available).
Clinical & Trials
Analytical Sensitivity
An IVD's ability to detect small quantities of an analyte.
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Where this term appears across MedTech Terms.
Ecosystems (3)
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
EUR-Lex·1ISO·1FDA·1
- 1
Regulation (EU) 2017/746, Articles 57 to 77VerifiedEUR-Lexeur-lex.europa.eu
- 2
ISO 14155 Standard PageVerifiedISOiso.org
- 3
FDA - Clinical Trials and Human Subject ProtectionVerifiedFDAfda.gov
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