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Orphan medical devices

Clinical evaluation and regulatory considerations for orphan medical devices.

Official catalogue · non-binding

Orphan medical devices guidance (1)

Catalogue entries are ordered as they appear in the European Commission catalogue.

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MDCG 2024-10Clinical evaluation of orphan medical devicesJune 2024
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
June 2024
Topics

Source document

  • MDCG 2024-10PDF · Unverified extraction previewOfficial source

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