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)

References

World Medical Association. WMA Declaration of Helsinki. Ethical principles for medical research involving human subjects. 64th WMA General Assembly, Fortaleza, Brazil; 2013.

European Committee for Standardization. Clinical investigation of medical devices for human subjects – good clinical practice (ISO 14155:2011); 2011.

European Committee for Standardization. Medical devices – application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01). vol EN ISO 14971; 2012.

Smith GCS, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ. 2003;327(7429):1459-1461.

Pugely AJ, Martin CT, Harwood J, Ong KL, Bozic KJ, Callaghan JJ. Database and registry research in orthopaedic surgery: part 2: clinical registry data. J Bone Joint Surg Am. 2015;97(21):1799-1808.

Labek G, Neumann D, Agreiter M, Schuh R, Bohler N. Impact of implant developers on published outcome and reproducibility of cohort-based clinical studies in arthroplasty. J Bone Joint Surg Am. 2011;93(Suppl 3):55-61.

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 25Jan.2020];6(1):70-5. Available from: https://journals.aboutscience.eu/index.php/aboutopen/article/view/294