Improving operational efficiencies through compliance

By Carlos Galamba, RQM+ Vice President, IVD Intelligence and Innovation

IVDR Paper FrontIt is imperative that manufacturers do not underestimate the time required to source the right clinical evidence for their products. As the risk to individual and public health increases with each device classification under the IVDR, the corresponding conformity assessment requirements also increase. This new rigorous risk-based classification means that an estimated 84% of IVDs now fall under Notified Body (NB) scrutiny compared to the mere 7% under the directive.

To ensure that IVDR compliance is as efficient as possible, manufacturers must check whether they can leverage existing clinical evidence from IVD submissions to the US Food and Drug Administration. If a company sells diagnostic products that are 510(K) cleared in the USA, then they may have a head start. It is likely they have already obtained a significant proportion of the supporting testing and performance data that is required to comply with some of the IVDR requirements.


  • Clarification on the clinical evidence required to comply with the EU In Vitro Diagnostic Regulation (IVDR)
  • Synergies between EU and US requirements, as well as a table that clearly presents areas where these synergies may be found
  • A detailed summary of clinical evidence requirements under the IVDR, including a checklist of questions to assess whether scientific validity, analytical performance and clinical performance have been sufficiently addressed in their Performance Evaluation Report (PER)

To access the “Performance Data and EU IVDR” white paper please fill out the form on the page.

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