Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective
DOI:
https://doi.org/10.33393/abtpn.2019.294Keywords:
Clinical evaluation, Medical Devices Regulation, Orthopaedics, Post-market clinical follow-up, VariantAbstract
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)
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Accepted 2019-07-11
Published 2019-07-31
