IVDR Overview White Paper

In Vitro Diagnostic Regulation (IVDR) Overview

Download White Paper

Download White Paper

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 new regulation will affect all EU member states and EFTA states immediately without needing to be transferred into the law of respective states, however national laws may be adapted to back some requirements in greater detail.

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benefits of downloading the white paper

  • Explore the In Vitro Diagnostic scope and definitions as well as the manufacturer requirements.
  • Seven Important Changes to Note
  • Classes and Related Risks
  • QMS and Technical Documentation Assessment
  • How to Succeed in transition to IVDR

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