Restoring Europe's global position in medical device innovation

Research in Europe has historically driven cardiovascular (CV) device innovation, a cornerstone of advancements in our speciality. Patients, who are central to invasive CV procedures and device implantation, benefit from life-saving, minimally invasive treatments that often lead to quicker recovery and improved quality of life. Percutaneous coronary intervention, transcatheter aortic valve implantation, percutaneous mitral valve repair, and cardiovascular implantable electronic devices exemplify innovations that have enabled millions of patients worldwide to enjoy better outcomes.

At a time when American support for scientific research, particularly medical research, has rapidly diminished, accompanied by sustained attacks on staff and the funding of US Department of Health and Human Services (HHS) agencies, such as the National Institutes of Health (NIH) or the U.S. Food and Drug Administration (FDA), research and innovation in Europe have taken on a new level of importance – and urgency.

To ensure continued progress, Europe must foster an environment that is conducive to medical technology development and validation. This approach not only sustains innovation but also maintains the highest safety standards.

The European Union’s (EU) Medical Device Regulation (MDR), adopted in April 2017,...