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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.

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