THE CHALLENGES FOR MANUFACTURERS OF THE INCREASED CLINICAL EVALUATION REQUIREMENTS UNDER THE EUROPEAN UNION MEDICAL DEVICE REGULATIONS

The European Union Medical Device Regulations EU MDR established new demanding clinical evaluation criteria
that substantially affect medical equipment manufacturers. The EU MDR imposes rules that require manufacturers to
provide advanced clinical proof and maintain continuous surveillance of their products under strict notification body
oversight. Manufacturers encounter multiple obstacles due to the enhancements that were introduced to improve
patient safety and device effectiveness. In addition, the shortage of approved notified bodies causes delays in market
entry for new devices and existing products. Small and medium-sized enterprises (SMEs) face adverse effects from
compliance costs, which leads them to eliminate products or stop selling in markets. Companies face challenges to
innovation since they must dedicate substantial resources to fulfill transforming regulatory standards. The following
study provides a deep examination of these regulatory challenges, including their industrial effects on the medical
device sector, along with manufacturer-approved navigation strategies.