Fact Sheet
Understanding the Summary of Technical Documentation (STED)
Learn about critical content needed for compliance with the IVDR
Jun 28, 2022
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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).

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