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…
