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EU postmarket surveillance plans for medical devices

PURPOSE: Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive‐reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evalu...

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Autores principales: Pane, Josep, Francisca, Reynold D.C., Verhamme, Katia M.C., Orozco, Marcia, Viroux, Hilde, Rebollo, Irene, Sturkenboom, Miriam C.J.M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771951/
https://www.ncbi.nlm.nih.gov/pubmed/31318470
http://dx.doi.org/10.1002/pds.4859
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author Pane, Josep
Francisca, Reynold D.C.
Verhamme, Katia M.C.
Orozco, Marcia
Viroux, Hilde
Rebollo, Irene
Sturkenboom, Miriam C.J.M.
author_facet Pane, Josep
Francisca, Reynold D.C.
Verhamme, Katia M.C.
Orozco, Marcia
Viroux, Hilde
Rebollo, Irene
Sturkenboom, Miriam C.J.M.
author_sort Pane, Josep
collection PubMed
description PURPOSE: Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive‐reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan. METHODS: This publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow‐up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. RESULTS: The results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device. CONCLUSIONS: The PMS plan may serve as a thorough tool for the benefit‐risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.
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spelling pubmed-67719512019-10-07 EU postmarket surveillance plans for medical devices Pane, Josep Francisca, Reynold D.C. Verhamme, Katia M.C. Orozco, Marcia Viroux, Hilde Rebollo, Irene Sturkenboom, Miriam C.J.M. Pharmacoepidemiol Drug Saf Review PURPOSE: Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive‐reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan. METHODS: This publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow‐up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. RESULTS: The results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device. CONCLUSIONS: The PMS plan may serve as a thorough tool for the benefit‐risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices. John Wiley and Sons Inc. 2019-07-18 2019-09 /pmc/articles/PMC6771951/ /pubmed/31318470 http://dx.doi.org/10.1002/pds.4859 Text en © 2019 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Review
Pane, Josep
Francisca, Reynold D.C.
Verhamme, Katia M.C.
Orozco, Marcia
Viroux, Hilde
Rebollo, Irene
Sturkenboom, Miriam C.J.M.
EU postmarket surveillance plans for medical devices
title EU postmarket surveillance plans for medical devices
title_full EU postmarket surveillance plans for medical devices
title_fullStr EU postmarket surveillance plans for medical devices
title_full_unstemmed EU postmarket surveillance plans for medical devices
title_short EU postmarket surveillance plans for medical devices
title_sort eu postmarket surveillance plans for medical devices
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771951/
https://www.ncbi.nlm.nih.gov/pubmed/31318470
http://dx.doi.org/10.1002/pds.4859
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