Impact of the new European medical device regulation: a two-year comparison.

Abstract

In recent years, the European Union has revised its regulatory framework for medical devices, primarily to improve patient safety and public health. The Medical Device Regulation (MDR) is fully applicable since May 2021, strengthening the requirements for all stakeholders. As a result, many companies are facing enormous challenges. The aim of this study was to assess the impact of the MDR on the orthopaedic aids industry. Two surveys were conducted: one shortly before the MDR became applicable (146 respondents) and a second survey almost two years later (233 respondents). Both surveys revealed that all businesses in the orthopaedic aids sector, regardless of size, have difficulty implementing the MDR. Key challenges include additional workload for technical documentation, increased resource expenditure and cost, and lack of clarity regarding the new requirements. Many companies are downsizing their product portfolio, resulting in potential supply shortages and a loss of competitive advantage and innovation for the medical device industry in Europe. The full extent of the MDR's impact on clinical practice is still unclear. However, many companies lack the necessary resources. The MDR can potentially be a bottleneck in the availability of medical devices.