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European Medicines Agency launches ‘orphan device’ pilot

Image: fernandozhiminaicela, via Pixabay

Pilot programme to advise developers of treatments and diagnostics for rare diseases

The European Medicines Agency has introduced a pilot programme to support the development of devices to treat or diagnose rare diseases.

Announced on 2 August, the EMA pilot programme will offer free advice to selected manufacturers and accredited assessment bodies on the status of ‘orphan’ devices and the data required for their clinical evaluation.

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