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IVDR Implementation: First Steps for Compliance for Products Already on the European Market

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In May 2022, the In Vitro Diagnostic Regulation (IVDR 2017/746) will replace the current In Vitro Diagnostic Directive (IVDD 98/79/EC), introducing new technical documentation requirements via performance evaluation and risk-based classification for In Vitro Diagnostics (IVDs). Performance guidance and expectations have already begun evolving from IVDD to IVDR, causing manufacturers the need to review and evaluate the quality of clinical evidence of their IVD products, previously created for IVDD. Several concerns discussed within the IVD community following this transition have been focused on the actual meaning of performance evaluation, level of performance data required for IVDR and what this means for established IVD manufacturers with products that have been on the market since the introduction of the IVDD in 1998. Overall, this has led to uncertainties around the impact and risk of using established performance data that is not in line with the latest editions of key guidelines.

NAMSA invites you to attend this webinar to gain a better understanding around the uncertainties facing IVD manufacturers with the new IVDR and provide clarity around performance needs with legacy products on the market.

Participants of this webinar will leave with a better understanding of:

  • Performance evaluation changes from IVDD to IVDR
  • Expected level of performance under the IVDR, especially considering new risk classifications
  • Widened performance gaps for products on the market for a long time considering risk classes and how to close them effectively

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