Overview 

John Richard Holborow, Global Head of Clinical Compliance, as he talks about claiming equivalence under the MDR and regulatory considerations 

Key Lessons and Takeaway

Topics covered in this presentation: 

• MDR Requirements 
• General Principles of Equivalence under MDR 
  
• Regulatory aspects of Equivalence based on classification 
• Clinical data for Equivalent devices
  
• Similar Devices 
• Technical, Biological & Clinical Aspects 
  
• Questions 
  

Presenter Information

Richard Holborow, Head of Clinical Compliance 

Related Webinars 

• Clinical Masterclass series: Well-established technologies 

• Clinical Masterclass series: Understanding Article 61 (10)

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

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