Throughout the entire lifecycle of the device the manufacture shall continuously assess whether there is adequate clinical evidence to affirm safe usage and support the device efficacy. A fundamental initial step is to have an adequate strategy in place to drive the whole process forward. Clinical evidence for a medical device is generally based on clinical data, i.e. results from the clinical use of the device or an equivalent device. If there is no previous clinical data, a clinical investigation may be required. For IVD-devices, clinical evidence includes the results of performance evaluation, including scientific validity, analytical performance and clinical performance.

Generally clinical performance include:

• Clinical strategy and planning
• Risk management
• Literature review
• Clinical data collection/generation
• Data analysis and evaluation
• Clinical evaluation report
• Regulatory submission, if applicable
• Post market surveillance
• Periodic review and updates