30 Day Trial

ORTHOWORLD » Other Articles of Interest

Your EU Medical Device Regulation Guide

Big changes are underway for the regulation of medical devices on the European market, with the unveiling of the Medical Device Regulation 2017/745 (MDR). This regulation replaces the long-standing Medical Devices Directive 93/42/EEC (MDD), specifically MedDev 2.7/1 for medical devices, which was created in 1992 and most recently updated to Revision 4 in July 2016. The MDR is a significant deviation from the MDD and MedDev 2.7/1, especially when it comes to clinical evaluations, and it is important to implement necessary changes to your literature searches, postmarket surveillance and postmarket clinical follow-up in the 2017-2018 timeframe to be prepared for MDR by 2020. BONEZONE author Debra Munro offered a set of guidelines for making a smooth transition.

Read more on MDR guidelines.