New European Union law on medical devices: will it truly protect patients from malfunctioning cardiac implantable electronic devices?-Reference-Cited by-同舟云学术

New European Union law on medical devices: will it truly protect patients from malfunctioning cardiac implantable electronic devices?

Published:2021-09-08 Issue:1 Volume:8 Page:1-3
ISSN:2058-5225
Container-title:European Heart Journal - Quality of Care and Clinical Outcomes
language:en
Short-container-title:

Author:

Wierda Eric¹^ORCID,de Mol Bas²,van Veghel Denns³,Ploem Corrette⁴

Affiliation:

1. Department of Cardiology, Amsterdam University Medical Center, Meibergdreef 9 1105 AZ Amsterdam, The Netherlands

2. Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Meibergdreef 9 1105 AZ Amsterdam, The Netherlands

3. Department of Cardiology and Cardiothoracic Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2 5623 EJ Eindhoven, The Netherlands

4. Department of Ethics, Law and Medical Humanities, Health Law Section, Amsterdam University Medical Center, Meibergdreef 9 1105 AZ Amsterdam, The Netherlands

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine,Health Policy

Link

http://academic.oup.com/ehjqcco/advance-article-pdf/doi/10.1093/ehjqcco/qcab064/40397082/qcab064.pdf

Reference8 articles.

1. Health technology assessment in interventional electrophysiology and device therapy: a position paper of the European Heart Rhythm Association;Boriani;Eur Heart J,2013

2. Implementing the new European Regulations on medical devices-clinical responsibilities for evidence-based practice: a report from the Regulatory Affairs Committee of the European Society of Cardiology;Fraser;Eur Heart J,2020

3. Recalls of cardiac implants in the last decade: what lessons can we learn?;Zhang;PLoS One,2015

4. Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices;Gagliardi;BMJ Qual Saf,2018

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