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

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

 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...

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Bibliographic Details
Main Authors: Peter Fennema, Hassan Achakri
Format: Article
Language:English
Published: AboutScience Srl 2019-07-01
Series:AboutOpen
Subjects:
Clinical evaluation
Medical Devices Regulation
Orthopaedics
Post-market clinical follow-up
Variant
Online Access:https://journals.aboutscience.eu/index.php/aboutopen/article/view/294
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spelling doaj-4255954e004e45e9b7e28af30d890c8f2020-11-25T03:19:28ZengAboutScience SrlAboutOpen2465-26282019-07-016110.33393/abtpn.2019.294Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspectivePeter Fennema0Hassan Achakri1AMR Advanced Medical Research, Clinical Evidence, Männedorf - Switzerland2Zimmer Biomet, Clinical Affairs, Winterthur - Switzerland  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) https://journals.aboutscience.eu/index.php/aboutopen/article/view/294Clinical evaluationMedical Devices RegulationOrthopaedicsPost-market clinical follow-upVariant
collection DOAJ
language English
format Article
sources DOAJ
author Peter Fennema
Hassan Achakri
spellingShingle Peter Fennema
Hassan Achakri
Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective
AboutOpen
Clinical evaluation
Medical Devices Regulation
Orthopaedics
Post-market clinical follow-up
Variant
author_facet Peter Fennema
Hassan Achakri
author_sort Peter Fennema
title Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective
title_short Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective
title_full Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective
title_fullStr Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective
title_full_unstemmed Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective
title_sort getting your devices ready for mdr compliance – a clinical approach and orthopaedic device manufacturers’ perspective
publisher AboutScience Srl
series AboutOpen
issn 2465-2628
publishDate 2019-07-01
description  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)
topic Clinical evaluation
Medical Devices Regulation
Orthopaedics
Post-market clinical follow-up
Variant
url https://journals.aboutscience.eu/index.php/aboutopen/article/view/294
work_keys_str_mv AT peterfennema gettingyourdevicesreadyformdrcomplianceaclinicalapproachandorthopaedicdevicemanufacturersperspective
AT hassanachakri gettingyourdevicesreadyformdrcomplianceaclinicalapproachandorthopaedicdevicemanufacturersperspective
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