The International Medical Device Regulators Forum is conducting a pilot test of a comprehensive table of contents suitable for use in pre-market applications around the world. In Phase 1, which runs through May of this year, IMDRF is asking larger-sized manufacturers to test the feasibility of assembling a regulatory submission for a high-risk medical device according to a proposed table of contents developed by an IMDRF working group. Participating manufacturers may base their test submission on an existing approved device, or a new real or fictional product.
Regulators who serve on IMDRF’s Regulated Product Submissions Working Group will review the test submissions for their regulatory functionality, including how easy it is to locate information, implications for product...