The scope of this guidance document is limited to the information participating IMDRF Regulatory Authorities require in medical device regulatory review reports, the format of reports, and the information necessary for participating IMDRF RAs to effectively use the regulatory review reports in accordance with their legislation and regulations.
Additional requirements for CAB certification decisions are included in IMDRF/GRRP WG/N59.
This document applies to all medical devices except IVD medical devices.
This document does not apply specifically to products that do not meet the definition of a medical device in IMDRF/GRRP WG/N47 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices. However, the contents and approach within this guidance may be relevant, as determined appropriate by the applicable RA, to documenting the evaluation of a product that is not a medical device.
This document is intended to identify the type of information a CAB would be expected to review during evaluation of a regulatory submission. This document does not apply specifically to RAs. Some RAs, however, may choose to use elements of this document in reviewing regulatory submissions themselves.