IVDR Performance Evaluation
Continuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56.
Definition
Article 56 of Regulation (EU) 2017/746 requires manufacturers to plan, conduct, and document a performance evaluation covering scientific validity, analytical performance, and clinical performance across the device's lifetime. The evaluation is documented in a Performance Evaluation Plan and Report and updated through Post-Market Performance Follow-up.What this means in practice
Performance evaluation is the IVDR analogue to the MDR clinical evaluation but with three pillars, not one. Notified bodies expect each pillar to be evidenced with its own dataset and pre-specified acceptance criteria before CE certification.- •Merging the three pillars into a single narrative. Notified bodies read them as separate evidence streams.
- •Reusing MDR clinical evaluation templates. IVDR Annex XIII structure is distinct.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsThe ability of an IVD to correctly detect or measure a particular analyte.
The 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.
The association of an analyte with a clinical condition or physiological state.
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, Article 56 and Annex XIIIVerifiedEUR-Lexeur-lex.europa.eu
- 2
MDCG 2022-2 Performance Evaluation GuidanceUncheckedMDCGhealth.ec.europa.eu
- 3
RAPS Regulatory FocusVerifiedRAPSraps.org
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