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On May 26, 2021, the European Union (EU) implemented REGULATION (EU) 2017/745, the “Medical Device Regulation,” or MDR. After its first year in existence, the medtech community’s initial concerns with the MDR’s requirements have now become a matter of increasing frustration for many, including those of us who are dedicated to advancing the clinical adoption of focused ultrasound. This commentary examines the current situation for EU medical devices and the MDR’s impact on focused ultrasound’s technological development.

Intensity modulated radiation therapy (IMRT) technology was pioneered in the early 1990s by a small startup, NOMOS, founded by a neurosurgeon and staffed by engineers with no background in the field of radiation oncology. The regulatory application process for the NOMOS Peacock product began a short three years after initial testing of the system. This was possible in part because IMRT was built on a stable, already authorized radiation therapy platform with easily identifiable predicate devices.

An important change in reimbursement for German patients with essential tremor has occurred. On April 21, 2022, the German Federal Joint Committee governing healthcare in Germany (Gemeinsamer Bundesausschuss or G-BA) favorably amended its ruling on patient eligibility for focused ultrasound treatment and reimbursement.

Financial success is critical to the clinical utilization of a new medical technology, at least in the US. Because the US healthcare system is based on reimbursing for procedures performed rather than outcomes achieved, the decision to invest in a new technology is based as much on the dollar amount that can be charged for using it as it is on whether it results in better outcomes. The proper goal for any healthcare delivery system is to improve patient outcomes achieved per dollar spent. A positive revenue stream is achieved when a facility is paid more for performing a procedure than it costs to perform the procedure. This requires a knowledge of cost and accurate and reliable measures of outcome; however, calculating costs is not an easy proposition.