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Technical documentation

IVD Performance Evaluation

Labquality helps manufacturers comply with the clinical evidence requirements of the IVD Regulation.

Performance evaluation

Performance evaluation is a requirement in the In vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
It refers to an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device.

Before any in vitro diagnostic medical device can be legally placed on the EU market, a manufacturer must comply with the requirements of the IVD Regulation. Clinical evidence shall support the intended use of the device and be based on a continuous process of performance evaluation.

Performance evaluation shall demonstrate the scientific validity, analytical performance and clinical performance of the device and it shall follow a performance evaluation plan. The clinical evidence derived from the performance evaluation shall provide scientifically valid assurance that the relevant safety and performance requirements of the IVD Regulation are fulfilled.

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Labquality

How can we help?

Labquality helps manufacturers comply with the clinical evidence requirements of the IVD Regulation by:
  • making the performance evaluation plan
  • making plans and reports for analytical performance studies
  • demonstrating the scientific validity through a systematic literature review
  • making plans and reports for clinical performance studies
  • making the performance evaluation report
Meeri Säily

Contact us for more information

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Meeri Säily
Sales Manager
contact-email
meeri.saily@labquality.com

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