Orphan Devices Pilot Program Tackles Parliament’s Proposal Head On

 
• By Amanda Maxwell
  
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The need for the EU to foster the development of orphan devices, intended for smaller patient populations with less commercial promise, is well documented. At last, action is starting.

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Infants Are Among Those Who Benefit From Orphan Devices For Rare Diseases • Source: Shutterstock

The European Medicines Agency has introduced a pilot program for expert panels to assist with the development and evaluation of orphan medical devices.

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.

This program provides free advice to selected manufacturers and notified bodies on orphan device status and the data needed for...

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