Future EU Regulatory Framework

Irish Medtech regulatory priorities for Irish and European policy makers

Industry supports the goals of the Medica Device Regulation (MDR) / In Vitro Diagnostics Regulation (IVDR) legislation however, industry is seriously concerned by the unintended consequences of the implementation challenges, such as unpredictable and long timelines for approval, increased costs especially impacting SMEs and inconsistent interpretations of regulations, resulting in reduced patient access to current and innovative devices in Europe.

Irish Medtech is calling for comprehensive structural reform of medical technologies' regulation. This must be a priority for policymakers in the next European Commission and Parliament to

• ensure EU patients have access to latest medical devices first
• maintain EU patients access to existing products 
• restore Ireland and Europe’s global competitiveness in medtech. 
  

Comprehensive Structural Reform needs to address efficiency, innovation, and governance, all while maintaining the regulations’ high level of device safety and performance. 

For further information click here