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Why EU Patients Need Regulation That Aids Access To Orphan Devices

 
• By Eliza Slawther

Children and patients with rare diseases across the world need better access to medical devices, but new EU regulation fails to support manufacturers of such products. A recent journal article highlights why orphan devices are vital and the need for improved regulation.

Rare Disease
• Source: Shutterstock

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

The Working Group on Medtech For Rare Diseases was established by the International Rare Diseases Research Consortium (IRDiRC) and the Netherlands’ University of Twente in early 2022. Its members represent countries from across the globe, with more than half of these being European countries.

In a previous interview with the organization, Medtech Insight detailed the group’s call for experts to author articles as part of its thematic journal collection. (Also see "

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