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In Vitro Diagnostic Regulation (IVDR) Overview

White Paper

About IVDR

The IVDR is the new regulatory basis for in vitro diagnostic medical devices to be available on the European market. This will replace the EU’s current In Vitro Diagnostic Directive 98/79/EC (IVDD) on in vitro diagnostic medical devices.

This white paper will explore the In Vitro Diagnostic scope and definitions as well as the manufacturer requirements.

Discover how TÜV SÜD can help your business safely and effectively face the complexities of bringing your product to market.

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