The European Medicines Agency (EMA) has launched a pilot program designed to support the development and assessment of orphan medical devices within the European Union (EU).

This initiative provides free advice from medical device expert panels to selected manufacturers and notified bodies regarding orphan device status and the data required for clinical evaluation.

The pilot is scheduled to run until the end of 2025, with the aim of establishing a long-term support mechanism for orphan devices.

Orphan devices are those intended for diseases or conditions that affect a small number of individuals each year (no more than 12,000 in the EU annually).

These devices typically address rare diseases or conditions with insufficient diagnostic or therapeutic alternatives, thus fulfilling an unmet medical need.

Manufacturers can consult expert panels at different stages of developing their device’s clinical strategy. Notified bodies might also seek advice during specific phases of the conformity assessment process.

The new pilot program emphasizes support for specific types of orphan medical devices, including those for severe or life-threatening conditions, devices intended for children, and innovative devices with substantial potential clinical benefits.

In June 2024, the Medical Device Coordination Group, representing all EU Member States, issued updated guidance on the clinical evaluation of orphan medical devices. This guidance defines how a device can be classified as orphan under the EU Medical Devices Regulation and provides instructions on fulfilling clinical evidence requirements.

This pilot initiative is part of the European Medicines Agency’s broader regulatory support for medical device expert panels, a program launched with new EU legislation.

Since March 1, 2022, the Agency has been aiding these panels in evaluating high-risk medical devices and in vitro diagnostic devices through scientific assessments of clinical and performance evaluations.

Early guidance for manufacturers, especially small and medium-sized enterprises, is crucial for fostering innovation and ensuring the development of safe and effective devices that meet patient needs.

The orphan device pilot will run in parallel with the scientific advice pilot, which addresses clinical development strategies and investigations for devices meeting unmet needs.

Source: ema.europa.eu

 

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