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. 

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Europe is undergoing one of the biggest regulatory framework changes in over 20 years, with the incoming Medical Device Regulations and In Vitro Diagnostic Medical Device Regulations with dates of application in 2021 and 2022 respectively. This represents challenges for companies who are navigating and transitioning from the Medical Device Directives and In Vitro Diagnostic Medical Device Directives. The Forum is comprised of QA/RA professionals who receive the latest information from Europe, regulators and notified bodies, and who engage in sharing best practice, developing homogenous interpretation and implementation of regulatory and standards requirements. Topics include auditing trends, information on skills and skills development, regulatory compliance, quality assurance, and third country information.   

Who should get involved? QA/RA professionals, specialists, and quality engineers. 

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