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

Insights & Media

Discover insights from our experts

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Medical Device Lifetime

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Using Standards to Demonstrate Conformity

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Innovative solutions for Sterile Medical Devices

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MDCG 2022-6 Medical Device Coordination Group Document

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Nanomaterials and Nanotechnology in Medical Devices

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Medicinal and Biologics Medical Devices

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