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Regulatory Affairs, Medical Devices

Data Report: Implementation of EU MDR

Posted by on 11 October 2021
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With organizations now 5 months in following the EU MDR entering into application on 26 May 2021, there are a number of questions facing the industry. What are the biggest challenges facing organizations, both internally with optimizing processes and externally with issues out of their control? How many products have been registered under MDR and how many extended under the MDD? And what exactly are the requirements of ‘sufficient clinical evidence’?

MedTech Summit conducted a survey (Aug 2021) of medical device professionals across Europe and the world to answer these questions. This report based on 96 responses explores the data, revealing unique insights into how organizations have fared with EU MDR implementation and the biggest obstacles that still remain.

Explore the full report by clicking on the image above or here.

Key Insights

  • 43% of organizations have withdrawn products from the market as a result of the transition to the EU MDR
  • 75% of products are still registered under an MDD extended certificate
  • 18% of respondents feel their company's EU MDR processes are currently inefficient
  • Just 21% feel their organization fully understands the requirements for ‘sufficient clinical evidence’
  • 51% need more staffing to ensure their CERs are valid
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