Webinar
Medical Devices

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.

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This Webinar:

The MDR requirements around Article 61 (10).
What data can be used to support Article 61 (10).
Examples of devices suitable for Article 61 (10).
Considerations for the CER and Article 7 claims.

Contributors

Understanding Article 61 (10) – When Clinical Data not deemed appropriate

BSI’s understanding of the occasions when it is appropriate that no clinical data is required for clinical evaluation.

Contributor
Richard Holborow

Head of Clinical Compliance, BSI.

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