Appendix II DEVICE MASTER FILE FOR MEDICAL DEVICES...

Appendix II DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary: An executive summary shall be provided by the manufacturer and shall contain: 1.1 Introductory descriptive information on the medical device, the intended use and indication for use, class of device, novel features of the device (if any), shelf life of the device and a synopsis on the content of the dossier.