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    BSI Interactive Dedicated Review

    Greater Predictability for Technical Documentation Reviews.

    At BSI, we continually look for opportunities to enhance the experience we provide for our clients. As part of this commitment, we have enhanced our Interactive Dedicated Review service to provide manufacturers with greater predictability, visibility, and structure throughout the technical documentation review process.

    The enhanced approach looks to introduce a targeted 55-day active review timeline for technical documentation reviews, supported by agreed project planning, dedicated review resources, and structured touchpoints throughout the assessment.

    Key benefits of our interactive dedicated review include:

    • Greater visibility of assessment milestones and timelines
    • Earlier interaction between manufacturers and review teams
    • Dedicated Scheme Manager support throughout the review
    • More structured management of questions and responses

    As part of the enhanced service, manufacturers can benefit from a more transparent and predictable review experience while maintaining the independence, rigour and technical quality expected from BSI.

    Important information about the 55-day active review timeline

    The targeted 55-day timeline applies to eligible technical documentation reviews conducted by BSI and is measured from the agreed review start date through to completion of the technical documentation assessment.

    The timeline:

    • Applies only to eligible reviews (excluding PSUR, SSCP, AIMD systems and IVD CDx).
    • Excludes manufacturer response periods ("stop clocks") and any additional timelines associated with Competent Authority consultation activities.
    • Depends on the timely submission of complete documentation and manufacturer responses.
    • Does not include application queue times, final certification decision-making or EUDAMED certificate upload activities.

    If you're considering certification, talk to us early. This gives us an opportunity to help you understand the certification process, timelines and requirements.

    Get in touch with our experts today to discuss your requirements and learn how we can help.