Compiling your STED is an important part of the EU CE-Mark process and is required to comply with the In Vitro Diagnostic Medical Devices Regulation [EU] 2017/746. Download this fact sheet to learn the the components of STED, why it is important, which regulations require it, and how you can prepare a STED.

IQVIA MedTech's dedicated regulatory team will help you in determining your devices' classification and grouping of products as per the In Vitro Diagnostics Regulation (IVDR).