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.
The European Academy of Paediatrics (EAP), along with 22 clinical associations, are calling on the European Commission to take urgent policy actions to prevent the loss of medical devices used in pediatric or orphan disease patients caused by medtech regulatory pressures in the region.
The implementation of the Medical Device Regulation has “unintentionally resulted in increased time and costs for manufacturers,” the clinical associations...
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