The performance evaluation is a requirement for IVD software under the IVDR (formerly the IVDD). It’s somewhat similar to the clinical evaluation for medical devices, but focused less on clinical data and more on (you guessed it) performance.
The best news is that we’ve published all our Performance Evaluation templates for free! Check them out below.
Also note that we have many more templates besides the ones for Performance Evaluation - head over to our templates page for more templates.