37 lines
1.7 KiB
Plaintext
37 lines
1.7 KiB
Plaintext
{{RegDocument
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| area_of_validity = EU
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| scope = IVD
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| document_type = Regulation – Article Reference
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| name = IVDR (EU) 2017/746 – Article 56 & Annex XIII Part A: Performance Evaluation
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| version = 2017/746
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| source = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746#d1e4774-1-1
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| language = EN, DE, FR
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| status = Current
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| restricted_access = No
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}}
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Article 56 and Annex XIII Part A of the IVDR define the requirements for performance evaluation of IVDs. Performance evaluation is the IVD equivalent of clinical evaluation under the MDR.
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== Summary ==
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Manufacturers must demonstrate that their device achieves its intended performance through a systematic and planned process covering scientific validity, analytical performance, and clinical performance.
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Key obligations:
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* Article 56 – Performance evaluation requirements and documentation
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* Annex XIII Part A – Performance evaluation plan (PEP) and performance evaluation report (PER)
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The three pillars of performance evaluation:
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* **Scientific validity** – the association between the analyte and a clinical condition or physiological state
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* **Analytical performance** – the ability to correctly detect or measure a particular analyte (sensitivity, specificity, precision, etc.)
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* **Clinical performance** – the ability of the device to yield results correlated with a clinical condition in a defined target population
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== Related documents ==
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* [[In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746]] – Parent document
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[[Category:In Vitro Diagnostics]]
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[[Category:Clinical]]
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[[Category:Performance Evaluation]]
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