Miriam Di Fonzo -

The European Medicines Agency (EMA) has launched a groundbreaking pilot program designed to enhance the development and regulatory support for orphan medical devices within the European Union. This initiative offers manufacturers and notified bodies complimentary advice from expert panels, focusing on the clinical evaluation of devices aimed at treating rare and life-threatening conditions, particularly those affecting children. This pilot, which runs until the end of 2025, seeks to streamline the pathway for innovative devices, ensuring that patients with limited treatment options gain access to much-needed solutions.

Key features of the program include prioritized support for devices targeting pediatric conditions and a commitment to fostering innovation in areas where medical needs are currently unmet. By providing expert guidance at no cost, the EMA hopes to mitigate the challenges associated with bringing orphan medical devices to market, thereby accelerating access to these critical technologies.

This initiative represents a significant step forward in the EU’s efforts to support medical innovation and improve patient outcomes in rare diseases.

RPN will provide any further update and is available to provide full support for Medical Devices activities.

Feel free to contact us at info@regulatorypharmanet.com

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