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.Examples
- A manufacturer conducted a performance evaluation to demonstrate the scientific validity of a new genetic test for a specific disease, confirming the relevance of the target marker to the condition.
- For an IVD measuring a blood biomarker, the analytical performance evaluation confirmed its accuracy, precision, and linearity across the clinically relevant measurement range.
- A clinical performance evaluation was performed to show that an IVD for infectious disease screening correctly identifies positive and negative cases in a target patient population, providing data on its diagnostic sensitivity and specificity.
- •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.
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1Regulation (EU) 2017/746, Article 56 and Annex XIIITier 1 VerifiedEUR-Lexeur-lex.europa.eu
- 2MDCG 2022-2 Performance Evaluation GuidanceTier 2 UncheckedMDCGhealth.ec.europa.eu
- 3RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
Inline markers like [1] jump to the matching reference above.