The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
This document was developed for in-vitro diagnostics medical device (IVD) market authorization submissions. Market authorization
submissions for combination products are out of scope; refer to each specific regulator for guidance regarding combination products.