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©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Mar 18, 2016; 7(3): 162-166
Published online Mar 18, 2016. doi: 10.5312/wjo.v7.i3.162
Published online Mar 18, 2016. doi: 10.5312/wjo.v7.i3.162
New regulations for medical devices: Rationale, advances and impact on research and patient care
Gerold Labek, Department of Orthopaedic Surgery, Medical University of Innsbruck, 6020 Innsbruck, Austria
Harald Schöffl, Department for Trauma Surgery, General Hospital Linz, 4020 Linz, Austria
Christian Ioan Stoica, Clinica Fiosor de Foc, 060274 Bucharest, Romania
Author contributions: Labek G drafted, finalised and submitted the manuscript, carried out the literature review, contributed to the perspective of elective orthopaedic surgery, know-how from international register collaboration and as expert to regulators’ working groups; Schöffl H provided content related to trauma surgery and implants and provided a critical review of the draft and final article; Stoica CI contributed through his experience as the Head of the Romanian Arthroplasty Register to the perspective from a national level and conducted a critical review of the draft and final article.
Conflict-of-interest statement: The authors have no conflict of interests.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Gerold Labek, MD, Department of Orthopaedic Surgery, Medical University of Innsbruck, Innrain 52, 6020 Innsbruck, Austria. gerold.labek@i-med.ac.at
Telephone: +43-512-50481600 Fax: +43-512-50422701
Received: May 25, 2015
Peer-review started: May 27, 2015
First decision: June 26, 2015
Revised: December 7, 2015
Accepted: December 18, 2015
Article in press: December 21, 2015
Published online: March 18, 2016
Peer-review started: May 27, 2015
First decision: June 26, 2015
Revised: December 7, 2015
Accepted: December 18, 2015
Article in press: December 21, 2015
Published online: March 18, 2016
Core Tip
Core tip: In the next few years new worldwide regulations as well as the availability of register data will lead to a shift in scientific focuses. The interpretation of register and routine data will be associated with new methodological challenges. Monocenter follow-up studies will become less attractive. Publications based on large data sets from registers will continue to gain influence and cover general issues; clinical studies should focus on specific questions.