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)



Document Type:
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.

Go back

GMP Conferences by Topics