International Initiative Tackles Paucity Of Rare Disease Devices
An orphan device working group is calling on medtech experts to pen scientific journal articles.
What is the importance of medtech in diagnosing and treating rare diseases? This is among the key questions that an international working group aims to address through a collection of articles in the Orphanet Journal of Rare Diseases.
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Steps are being taken in the EU to address shortages of critical medical devices as a result of regulatory pressures, including those for use in children and for rare conditions, the European Commission’s Stella Kyriakides stated during a recent debate.
There are growing fears that the new EU medtech regulations could result in products used for children or rare diseases vanishing from the market. In an interview with Medtech Insight, regulatory expert Tom Melvin explains how these devices can be protected.
Medical devices used in pediatric heart surgeries and other products used for children and for orphan conditions may cease to be available in the EU due to the new Medical Device Regulation compounding existing market pressures, researchers have warned.