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    Article 54 Understanding the Clinical Evaluation Consultation Process
    • Webinar
      Medical Devices

    Article 54 Understanding the Clinical Evaluation Consultation Process

    This webinar will provide the required information to manufacturers in accordance with Article 54 of the Medical Device Regulations EU 2017/745.

    Watch the Webinar View the Presentation

    In this Webinar:

    • Article 54 (1) outlines the classifications of devices that are potential subject to CECP.

    • What triggers CECP for a legacy device.

    • The CECP process - considerations of submitted documentation.

    • Article 54.3 & Article 61 (2).

    Class III implantable, class IIb active rule 12 administer or ARMS devices

    Information to manufacturers of class III implantable, and class IIb active rule 12 administer or remove medicinal substances (ARMS) devices.

    Richard Holborow, Head of Clinical Compliance, BSI

    Sheila Walsh, Clinical Regulatory Lead, Clinical Compliance Team, BSI
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