Europe takes great pride in its robust social security systems and the fundamental principles of equitable healthcare access. Medical technologies form an integral part of such quality healthcare and are crucial for all stages of the patient journey, from prevention and diagnosis, to treatment and cure.

Despite Europe’s fundamental strengths in delivering the highest standards of care with the help of innovative medical technology, there are growing indications that new and existing products will struggle to reach European patients and health systems in a timely manner.

Structural issues within the regulatory framework for medical technologies, IVDR and MDR, are resulting in unpredictability and delays, dampening innovation, and undermining confidence in the long-term viability of the framework. Left unaddressed, such issues will increasingly impact patients and health systems in Europe and erode the influence of Europe’s valued CE marking system.

In this position paper, MedTech Europe presents the challenges that medical technologies face under the European regulatory framework and comes forward with a 3-point vision for how a future system could look like. The vision is accompanied by recommended solutions to help start the conversation between all impacted stakeholders on the needed steps to reform the current system.