Join us live online for two half-day sessions on February 22-23, 2023 12:00p - 4:00pm ET.

During this virtual training, our hand-picked experts will share details about the changes to the standard and provide insight on other key topics around information security, the changing landscape, and new threats.

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Course Details

Clinical Masterclass series: Understanding Article 61 (10)

Course Area

Medical Devices


Available for 90 days after enrollment

Course Fee

No charge

E-learning content is available on demand!


Course Details


John Richard Holborow, Global Head of Clinical Compliance, as he elaborates on BSI's understanding of the occasions when it is appropriate that no clinical data is required for clinical evaluation. 

Key Lessons and Takeaway

Topics covered in this presentation: 

  • The MDR requirements around Article 61 (10) 
  • What data can be used to support Article 61 (10)? 
  • Examples of devices suitable for Article 61 (10) 
  • Considerations for the CER
  • Article 7 - Claims 

Presenter Information

Richard Holborow, Head of Clinical Compliance 

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For questions regarding any of our courses, contact us or call 1.800.217.1390.


For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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