The International Medical Device Regulators Forum (IMDRF) recently released three final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices, replacing earlier versions of the documents developed by the Global Harmonization Task Force (GHTF).
In the 30-page document on clinical evaluations, IMDRF defines a clinical evaluation as “a set of ongoing activities that use scientifically sound methods for the assessment and analysis of clinical data to verify the safety, clinical performance and/or effectiveness of the medical device when used as intended by the manufacturer.”
IMDRF explains that a clinical evaluation should take place throughout the lifecycle of a device and is used to determine what data will be necessary for marketing a device and whether clinical investigations are needed.
The guideline provides an overview of the general principles of clinical evaluation for medical devices, in vitro diagnostics (IVDs) and software as a medical device (SaMD) products. It discusses a range of issues including data sources and documentation, appraising and analyzing clinical data and compiling a clinical evaluation report…