Challenges Of Orphan Devices Reaching Children

The guidance document, MDCG 2024-10 Clinical evaluation of orphan medical devices, points out that in many cases, orphan devices are intended for use solely or predominantly in minors and paediatric populations, and/or in emergency situations.

But, it says, generating clinical data efficiently for small patient populations is difficult, especially for vulnerable groups due to ethical and regulatory requirements, including infants and children.

Compliance with MDR requirements, including certification, it says, can lead to increased and unpredictable financial costs, hindering manufacturers from placing orphan devices on the EU market due to low sales not covering expenses.

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