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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EU policymakers must implement regulatory changes targeted at devices for pediatric and rase diseases to prevent essential products from becoming unavailable to EU patients, 23 clinical organizations say in an open letter penned to the EU commissioner for health and food safety.
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.
The EU Council has adopted proposed changes to the EU Medical Device Regulation that will see transition deadlines extended for legacy devices. This completed final legislative step means that the amendments are set to enter force in around a week’s time, on 15 March.