The need of innovation and of preservation of well-established techniques in the era of MDR for improving outcomes.

Abstract

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 challe