Report: EU IVDR State of the Industry 2021

In June 2021, NSF partnered with Informa to launch a huge industry survey on how prepared organizations were just under a year until the IVDR date of application.

The survey asked questions around the impacts of the global COVID-19 pandemic, the industry’s readiness to meet the IVDR requirements, whether notified bodies have the capacity and time to handle all conformity assessments heading their way, changes to PMS and clinical requirements, and confidence in the resources manufacturers have to maintain compliance once their CE marks are approved.

Key insights from the survey:

• Only 15% of organizations are fully prepared to hit the IVDR deadline of May 26, 2022
• 55% want more guidance from the European Commission and/or the MDCG
• 38% are planning to transfer their IVD product portfolio to IVDR
• 21% currently have an IVDR-certified product
• 95% say the COVID-19 pandemic has impacted their IVDR implementation