Clinical evidence is a critical component for medical device development, regulatory approval, and ongoing assessment of device safety and effectiveness. Manufacturers must conduct robust clinical evaluations/performance evaluation, adhere to regulatory requirements, and ensure ethical conduct in clinical research to demonstrate the clinical benefits and safety of their medical devices.

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 includes:

  • 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

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