{{RegDocument
| area_of_validity  = EU
| scope             = IVD
| document_type     = Regulation – Article Reference
| name              = IVDR (EU) 2017/746 – Article 56 & Annex XIII Part A: Performance Evaluation
| version           = 2017/746
| source            = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746#d1e4774-1-1
| language          = EN, DE, FR
| status            = Current
| restricted_access = No
}}

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.

== Summary ==

Manufacturers must demonstrate that their device achieves its intended performance through a systematic and planned process covering scientific validity, analytical performance, and clinical performance.

Key obligations:

* Article 56 – Performance evaluation requirements and documentation
* Annex XIII Part A – Performance evaluation plan (PEP) and performance evaluation report (PER)

The three pillars of performance evaluation:

* **Scientific validity** – the association between the analyte and a clinical condition or physiological state
* **Analytical performance** – the ability to correctly detect or measure a particular analyte (sensitivity, specificity, precision, etc.)
* **Clinical performance** – the ability of the device to yield results correlated with a clinical condition in a defined target population

== Related documents ==

* [[In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746]] – Parent document

[[Category:In Vitro Diagnostics]]
[[Category:Clinical]]
[[Category:Performance Evaluation]]