MedTech Europe and its members fully support the objectives of the medical technology regulations IVDR and MDR to establish a “robust, transparent, predictable and sustainable regulatory framework for [in vitro diagnostic] medical devices which ensures a high level of safety and health whilst supporting innovation”.
However, after almost six and a half years of implementation, the IVDR and MDR have still not fully achieved these objectives.
While considerable work has been done by all stakeholders to address the short-term implementation challenges, there are structural issues in the regulatory system which make it slow, unpredictable, costly and complex, and lacking in agile pathways for innovation. These structural issues cannot be solved through the implementation of IVDR and MDR alone.
MedTech Europe is calling for comprehensive reform to make the regulations work for patients and European health systems. Reform should address the three key areas of efficiency, innovation and governance, all while maintaining the regulations’ high level of device safety and performance.
Read the vision for the future of the medical technology industry in this position paper.