EU Trials Involving Medical Devices Under MDR/IVDR
Device trials face unique challenges compared to pharmaceuticals:
Oncology Devices: High-risk implants require rigorous safety and performance documentation.
Pediatrics: Additional ethical safeguards and device design considerations are mandatory.
Rare Diseases: Small patient populations demand innovative trial designs and EU-wide collaboration.
Decentralized Trials: Remote device monitoring introduces GDPR and validation challenges.