Overview

This webinar will discuss the concept of well-established technologies under the medical device regulations and how to interpret the four criteria defined in MDCG 2020-6. This session will also cover the levels of clinical evidence required for these devices to support your clinical evaluation.

Key lessons and takeaway

Topics covered in this presentation: 

• What is meant by the term 'WET'?(Article 52 (5))
• What devices can be considered WET according to the MDR?
• MDCG 2020-6 & the term 'WET'
• 4 Criteria of WET from MDCG 2020-6
• MDCG 2020-6 Key Messages
• When to consider sufficient levels of evidence?

Presenter information

Richard Holborow, Head of Clinical Compliance

Related Webinars

• Clinical Masterclass series: Understanding Article 61 (10)
  

• 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