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2 Years TODAY until the IVDR is mandatory

TICK TOCK! Two years and counting! 26 May 2022, the world will be a very different regulatory landscape for IVD industry, there are now just 2 years before the IVDR is mandatory for any IVD that does not have a Notified Body approval today.

At the peak of the IVDD when there was a full complement of IVD NBs approval times were a minimum of 3 months and could often take over 9 months in real time including the responses to questions. We now have more products to approve and fewer NBs and this will impact timelines. Qserve regularly survey webinar attendees, this is the state of readiness in April 2020:

• Not started: 12%

• Planning: 46%

• Completed GAP analysis: 19%

• Prepared Initial Technical Files & Procedures: 12%

• Implementation: 11%

This data suggests that there will be a crush for NB resource at the last minute. COVID-19 has demonstrated the need for the IVDR to cope with emerging pathogens so do not assume there will be an extension and take this anniversary as a call to action. 

Sue Spencer
Post date: May 26, 2020
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