Scientific validity, analytical performance and clinical performance
Performance evaluation of an IVD is a continuous process. In this process, data are assessed and analyzed to demonstrate…
- the scientific validity,
- analytical performance and
- clinical performance
…of that device for its intended purpose as stated by the manufacturer.
- Scientific validity means that an analyte is associated with a specific clinical condition or physiological state (IVDR, Article 2 (38)).
- Analytical performance means the ability of an IVD to correctly detect or measure a particular analyte (IVDR, Article 2 (40)).
- Clinical performance describes the ability to provide results that correlate with a specific clinical condition or physiological or pathological process or state (IVDR, Article 2 (41)).
While scientific validity can be mostly demonstrated based on literature, analytical and clinical performance are demonstrated and shown based on performance study data.
