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ISSN: 2333-9721
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-  2016 

Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive?

DOI: 10.1186/s13023-016-0393-3

Keywords: History of medicine, Rare diseases, Orphan drugs, Custom-made medical devices, Humanitarian-use devices

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Abstract:

Regulatory and economic frameworks stimulated the research and development of orphan drugs, but very little has been done for devices necessary for the in-vivo diagnosis, prevention and treatment of life-threatening conditions with a low prevalence/incidence

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