“Seven years after their publication, the Medical Devices and In Vitro Diagnostic Medical Devices Regulations continue to hamper access to lifesaving and life-sustaining medical technologies as they are plagued by inefficient and unpredictable processes, skyrocketing cost of compliance, insufficient support for innovation and a lack of accountable governance.”
MedTech Europe Appeals To Re-elected Von Der Leyen To Address MDR/IVDR Problems
Early and comprehensive reform of the MDR and IVDR is critical to address overregulation and unpredictable medtech regulatory processes, medtech tells reelected Commission President.