Overview 

Join Richard Holborow, Global Head of Clinical Compliance, as he looks at the BSI interpretation of MDCG 2020-1 and how clinical evaluation should be applied to this group of devices

Key Lessons and Takeaway

Topics covered in this presentation: 

• MDR Requirements 
• When a Clinical Evaluation of Software is required 
• MDCG 2020-1
• The clinical evaluation Process for MDSW 
• Considerations for Clinical Investigations 
• Equivalence & Article 61 (10) 
• 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: Claiming Equivalence under the MDR - regulatory considerations 

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