Why EU Patients Need Regulation That Aids Access To Orphan Devices

The Working Group on MedTech For Rare Diseases was established last year by international experts to research and improve the regulatory landscape for medical devices and technologies used to diagnose, treat or support individuals with rare conditions. The group has now published its first article, entitled “Orphan medical devices have come a long way” which argues that global regulators, including in Europe, should do more to support the development of and access to these products. It provides a succinct but impactful overview of the history of orphan devices.

The piece forms part of a thematic collection focused on tackling specific challenges faced by manufacturers of orphan devices in the Orphanet Journal of Rare Diseases.