scope:

This standard pertains to the clinical investigation in human subjets of those medical devices whose the clinical performance needs assessment before being placed on the market. This standard does not apply to in vitro diagnostic devices. This standard specifies the requirements - for the conduct of clinical investigations and documentation on whether the medical device achieves the performance intended by the sponsor; - to determine any undesirable side effects, under normal conditions of use; - to permit the assessment of the acceptable risks having regard to the intended performance of the medical device. This standard provides a framework for the preparation of written procedures for the organization, design, implementation, data collection and documentation of the clinical investigation.