Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective

A clinical approach to MDR compliance

  • Peter Fennema AMR Advanced Medical Research, Clinical Evidence, Männedorf - Switzerland https://orcid.org/0000-0002-3549-398X
  • Hassan Achakri 2Zimmer Biomet, Clinical Affairs, Winterthur - Switzerland
Keywords: Clinical evaluation, Medical Devices Regulation, Orthopaedics, Post-market clinical follow-up, Variant

Abstract

 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)

Published
2019-07-31
How to Cite
1.
Fennema P, Achakri H. Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective. Abtpn [Internet]. 31Jul.2019 [cited 12Nov.2019];6(1):70-5. Available from: https://journals.aboutscience.eu/index.php/aboutopen/article/view/294