Claiming Equivalence Under the MDR – Regulatory Considerations

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

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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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, 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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