Performance Study Application (IVDR)
Formal submission via EUDAMED required before commencing certain performance studies under IVDR Annex XIII and XIV.
Definition
Article 58 and Annex XIV set out the application procedure for performance studies. Interventional clinical performance studies, studies involving invasive sample-taking done only for the purpose of the study, and studies of companion diagnostics using leftover samples with additional testing must be authorised by the competent authorities of the Member States in which the study is conducted. Applications are submitted through EUDAMED using a single identification number (SIN).What this means in practice
The IVDR harmonises the performance-study route across Member States, replacing the fragmented national procedures of the IVDD era. Timelines mirror MDR clinical investigations: 10 days for validation, then 45 days (extendable) for substantive review.Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsThe ability of an IVD to yield results correlated with a clinical condition in the target population and intended user.
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
European Database on Medical Devices.
A study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2017/746, Articles 58 and 66VerifiedEUR-Lexeur-lex.europa.eu
- 2
MDCG 2022-19 Performance Study ApplicationUncheckedMDCGhealth.ec.europa.eu
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.