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?
Richard Holborow, Head of Clinical Compliance