IMDRF Issues Guidance on Clinical Evidence

The International Medical Device Regulators Forum (IMDRF) has issued new guidelines outlining the clinical evidence needed for approval of a medical device.

Clinical evidence is “an important component of the technical documentation of a medical device, which along with other design verification and validation documentation, device description, labelling, risk analysis and manufacturing information, is needed to allow a manufacturer to demonstrate conformity with the Essential Principles,” IMDRF said.

Clinical evidence should be reviewed and updated throughout the product life cycle by the manufacturer as new information relating to safety, clinical performance or effectiveness is obtained from clinical experience during marketing of the device or comparable devices, IMDRF said.