Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective
A clinical approach to MDR compliance
On 26 May 2017, the Medical Devices Regulation (MDR 2017/745) was published, with the aim of replacing the current Medical Devices Directive (MDD 93/43/EC). Following a transition period of 3 years, this regulation will be applied in full from 26 May 2020. This article describes and discusses the impact of MDR on the clinical evaluation and gives advice to manufacturers on the preparation, planning and implementation of processes to support compliance with the new regulation. (Market Access)
Copyright (c) 2019 The authors
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Authors contributing to AboutOpen agree to publish their articles under the CC Attribution-NonCommercial-NoDerivatives 4.0 license, which allows third parties to copy and redistribute the material providing appropriate credit and a link to the license but does not allow to use the material for commercial purposes and to use the material if it has been remixed, transformed or built upon.