Medical device regulation and dialysis practice - impact on patients, doctors and manufacturers

The medical device regulation (MDR) was adopted in 2017 to replace the medical device directive (MDD). Key changes included more rigorous clinical evidence requirements, increased scrutiny of notified bodies, and improved traceability of medical devices, with the overarching aim to improve their safety and quality. For chronic haemodialysis, the impact of the MDR on devices has been substantial, resulting in niche devices being no longer available, and critical shortages, especially in paediatric nephrology. The Eudial board discussed these developments and concluded that the MDR has had a clear negative impact on innovation. In conjunction with other emerging economic macro-trends, this development heightens the potential for disruptions within critical supply chains. We offer actionable recommendations to optimise the benefits of the MDR and to minimise unintended consequences.