In Vitro Diagnostic Regulation (IVDR)

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Overview Of In Vitro Diagnostic Regulation (IVDR)

European In Vitro Diagnostic Regulation (IVDR) is set to replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC).

The first step is to determine if the product is a medical device as defined by the Directive. The In Vitro Device Directive Article 1, point 2b defines an IVD as any medical device eg:

  • Reagent, Reagent Product
  • Calibrator, Control Material
  • Kit
  • Instrument, Apparatus
  • Equipment, System

Expertise

  • Dedicated experts’ team to support post-market surveillance (PMS)
  • Gap Analysis of IVDR General Safety and Performance Requirements
  • Clinical Performance Reports based on literature
  • Post Market Performance Follow up (PMPF) protocols and Reports
  • Post Market Surveillance (PMSR) Protocols and Reports

Advantages of In Vitro Diagnostic Regulation (IVDR)