“Orphan devices” are only intended for use is a small number of individuals with rare diseases. It is particularly challenging for those devices to meet the increased clinical evidence requirements under the MDR by generating clinical data.

This guidance discusses the challenges orphan devices face under the MDR's increased clinical evidence requirements. It proposes balanced application of MDR requirements to ensure adequate pre-market clinical data without hindering patient access.

For further details, please consult the reference provided.

 

 

Reference:
MDCG 2024-10 - Clinical evaluation of orphan medical devices