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Course Details

Clinical Masterclass series: Article 61 and MDCG 2020-6 - Well Established technologies

Course Area

Medical Devices

Availability

Available for 90 days after enrollment

Course Fee

No charge

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Course Details

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

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