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    Webinar - Understanding Article 61 10
    • Webinar
      Medical Devices

    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.

    Watch the Webinar View the Presentation

    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.

    Speakers

    Hear from the experts in this webinar

    Speaker

    Richard Holborow

    Head of Clinical Compliance, BSI

    More webinars in the 2022 Clinical Masterclass Series

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

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