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    Medical Personnel Discussing.
    • Brochure
      Medical Devices

    Best Practice Guidance

    This document covers the legislative aspects associated with clinical evaluation under MDR from a Notified Body perspective.

    Best practice guidance for clinical evaluation submission

    Download this brochure to find out more about:

    • General considerations for submission

    • The clinical evaluation documentation.

    • The clinical oversight process at BSI.

    • When to consider Article 61(10).

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