Webinar
Medical Devices

Clinical Masterclass Series 2022 Well Established Technologies

This webinar covers the concept of well-established technologies under the MDR and how to interpret the four criteria defined in MDCG 2020-6.

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In this webinar:

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.

Speakers

Hear from the experts in this webinar

Speaker

Richard Holborow

Head of Clinical Compliance, BSI

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Ensure your product maintains EU market access under the new, more stringent Medical Device Regulations (MDR).

This webinar will elaborate on BSI’s understanding of when it is appropriate to claim that no clinical data is required for clinical evaluation.

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Reviewing MDR Requirements, General principles of Equivalence under the MDR and Regulator aspects of Equivalence based on classification.

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Reviewing MDR Requirements, when a clinical evaluation of software is required and MDCG 2020-1.

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The medical device regulations specifically state that post-market clinical follow-up is a continuous process under the regulations.

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