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.

“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.”

Strong words from industry association MedTech Europe in a statement responding to news that Ursula von der Leyen has been...