The European Union Medical Device Regulation (MDR 2017/745) has introduced stricter requirements for clinical evidence, limited reliance on equivalence and expanded post-market surveillance for orthopaedic implants. While designed to improve patient safety following high-profile device failures, MDR implementation has been associated with longer certification timelines, increased costs and withdrawal of established implants, particularly in lower-volume indications. The central regulatory challenge is proportionality: novel devices require robust prospective evidence, whereas long-established implants with extensive clinical track records may warrant risk-based recertification pathways. Uniform regulatory application risks unintended consequences for intermediate- and lower-volume indications that fall between orphan-device provisions and standard MDR requirements. Orthopaedic societies may play a key role in developing speciality-specific evidence guidance to support regulators and notified bodies, improving clarity while maintaining patient safety and sustainable innovation.
Gordon et al. (Fri,) studied this question.