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Notified Body designation and scope, the impact of Brexit and Competent Authority and Notified Body interpretation of the regulations. Make sure you are up to date!

REPORT: EU IVDR State of the Industry 2021

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After a challenging four years of preparation for the EU IVDR, there is less than a year left on the clock. However, after facing the global COVID-19 pandemic in 2020, is industry ready to meet the IVDR requirements? Are there enough Notified Bodies with CE Marking and do they have the capacity and time to handle all IVDR certificates heading their way? Are PMS and Clinical teams ready to adapt to the longer-term commitments required? Are organizations confident in the resources they have to maintain compliance once their CE marks are approved?

MedTech Summit in association with NSF conducted a huge survey of medical device and IVD professionals across Europe and the world to discover the industry's answers to these questions. This final report based on 108 responses reveals unique insights into how prepared organizations are for IVDR implementation, the biggest challenges and how industry insiders are tackling them.

Explore or download the report above (or here).

Key Insights

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

Explore or download the report above (or here).

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