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    Medicinal Dossier Guidance - Two women wearing safety workwear seen in a pharmaceutical laboratory
    • Brochure
      Medical Devices

    Medicinal Dossier Guidance

    For devices which incorporate an ancillary medicinal substance and fall under Rule 14 of EU 2017/745 (MDR)

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    In this brochure:

    • Introduction to the Medicinal Dossier

    • Documentation requirements

    • Additional Guidance

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