Clinical Masterclass Series 2022 Understanding Article 61 (10)

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

This webinar:

Speakers

Speaker

Head of Clinical Compliance, BSI

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

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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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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