New EMA pilot programme for orphan medical devices

Orphan medical devices target rare diseases or conditions affecting a small number of individuals (fewer than 12,000 annually in the EU).

EMA's pilot program offers free advice from medical device expert panels to manufacturers and notified bodies regarding orphan medical device status and the data needed for their clinical evaluation.

The pilot programme is scheduled to run until the end of 2025.Though, the initiative aims to establish a long-term support framework for orphan medical devices, enhancing innovation and market access for critical medical solutions.

The project entails that manufacturers can seek advice during various development stages, while notified bodies can request guidance in relation to the conformity assessment.

EMA will prioritize devices for life-threatening conditions, pediatric use, or those with significant potential clinical benefits.

In this connection it is noted that in June 2024, the European Commission issued new guidance on the clinical evaluation of orphan medical devices and which provides criteria to determine their status under the EU Medical Devices Regulation (EU Regulation 2017/745). That guidance provides the criteria to determine when a medical device should be regarded as an orphan medical device and helps manufacturers and notified bodies to apply the clinical evidence requirements.

Read more about the new pilot programme to support orphan medical devices 

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