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.
Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVD MA ToC)
This document was developed for non-In-vitro diagnostics device (nIVD) market authorization submissions. Market authorization
submissions for combination products are out of scope; refer to each specific regulator for guidance regarding combination products.