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.
This document is intended to be used in evaluating a regulatory submission consistent with other IMDRF guidance, namely, IMDRF/RPS WG/N9. The headings in this document mirror those of IMDRF/RPS WG/N9 for consistency between information expected to be included in the regulatory submission and documentation of the CAB’s review of that submission.
IMDRF/RPS WG/N9 is primarily organized to accommodate a submission package structured with nested folders. The order of content in IMDRF/RPS WG/N9 is not intended to convey or describe the order in which content would be assembled.
Similarly, the order of content in this document is not intended to convey or describe the order in which a regulatory submission would be reviewed. For example, a regulatory review report should include an evaluation of the device classification and identification information (Chapter 1.01(B)), but this evaluation requires the review of information in subsequent Chapters: Device Description (Chapter 2.04) and the Indications for Use and/or Intended Use, and Contraindications (Chapter 2.05). If the regulatory review report follows a different structure, then the report should ensure that at least the same
content has been covered in the evaluation IMDRF/RPS WG/N9 is comprehensive in scope in that it includes both common (IMDRF) and regional content.
As a consequence, not all headings in IMDRF/RPS WG/N9 are applicable for all submission types and/or IMDRF jurisdictions. Similarly, not all headings of this document are relevant or reviewed to the same extent for all submission types, all device types, and/or all IMDRF jurisdictions. The relevance of
each chapter and the extent of review depends on the jurisdiction(s) for which the regulatory review is being conducted.