Overview 

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 

Related Webinars 

• Clinical Masterclass series: Well-established technologies

• Clinical Masterclass series: Claiming equivalence under the MDR – regulatory considerations

• Clinical Masterclass series Clinical evaluation for medical software & AI devices

• Clinical Masterclass series: Post market clinical follow up under MDR