This white paper was updated January 2022.
Written by Carlos Galamba, RQM+ Vice President, IVD Intelligence and Innovation, this white paper discusses EU IVDR clinical evidence requirements and how manufacturers can efficiently comply.
The clock is ticking on IVDR compliance, even with the progressive rollout for certain IVD classes. Underestimating the time required to source the right clinical evidence for your products could result in costly approval delays or removal from the market.
If you can leverage existing clinical evidence from diagnostic products that are 510(k) cleared in the U.S., you could have a head start.
Complete the form to access the Performance Data and EU IVDR white paper for free.