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Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals
BACKGROUND: In the European Union (EU), there are over half a million medical devices, varying from pacemakers to software. Medical devices play an important role in health care as they are used in diagnosis, prevention, monitoring, prediction, prognosis, treatment, or to alleviate disease. Medical...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10062684/ https://www.ncbi.nlm.nih.gov/pubmed/36997978 http://dx.doi.org/10.1186/s12913-023-09316-8 |
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author | Huusko, Juhamatti Kinnunen, Ulla-Mari Saranto, Kaija |
author_facet | Huusko, Juhamatti Kinnunen, Ulla-Mari Saranto, Kaija |
author_sort | Huusko, Juhamatti |
collection | PubMed |
description | BACKGROUND: In the European Union (EU), there are over half a million medical devices, varying from pacemakers to software. Medical devices play an important role in health care as they are used in diagnosis, prevention, monitoring, prediction, prognosis, treatment, or to alleviate disease. Medical devices are regulated in the EU by the Medical Device Regulation (MDR), which came into force on 25 April 2017 and into application on 26 May 2021. The demand for regulation arose from the need to establish a transparent, robust, predictable, and sustainable regulatory framework. This study aims to examine how the managers and regulatory professionals in health technology enterprises perceived the application of the MDR and what were their information needs regarding the MDR. METHODS: A link to an online questionnaire was sent to 405 managers and regulatory professionals representing health technology enterprises in Finland. The study included 74 respondents. Descriptive statistics were used to describe and summarise the characteristics of the dataset. RESULTS: Information related to the MDR was fragmented and the necessary information was sought from multiple information sources, while the Finnish Medicines Agency (Fimea) was regarded as the most important source of information and training provider. To some extent, the managers and regulatory professionals expressed their dissatisfaction with the performance of Fimea. The managers and regulatory professionals were not very familiar with the ICT systems provided by the EU. The size of an enterprise affected how many medical devices it manufactures and generally affected the views about the MDR. CONCLUSIONS: The managers and regulatory professionals understood the role of the MDR regarding the safety and transparency of medical devices. The available information regarding the MDR did not properly fit the needs of users and there seemed to be a gap in information quality. The managers and regulatory professionals had some difficulties understanding the available information. Based on our findings, we believe it is paramount to evaluate the challenges faced by Fimea and how it could improve its performance. To some extent, the MDR is regarded as a burden for smaller enterprises. It is important to highlight the benefits of ICT systems and to develop them to better meet the information needs of enterprises. |
format | Online Article Text |
id | pubmed-10062684 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-100626842023-03-31 Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals Huusko, Juhamatti Kinnunen, Ulla-Mari Saranto, Kaija BMC Health Serv Res Research BACKGROUND: In the European Union (EU), there are over half a million medical devices, varying from pacemakers to software. Medical devices play an important role in health care as they are used in diagnosis, prevention, monitoring, prediction, prognosis, treatment, or to alleviate disease. Medical devices are regulated in the EU by the Medical Device Regulation (MDR), which came into force on 25 April 2017 and into application on 26 May 2021. The demand for regulation arose from the need to establish a transparent, robust, predictable, and sustainable regulatory framework. This study aims to examine how the managers and regulatory professionals in health technology enterprises perceived the application of the MDR and what were their information needs regarding the MDR. METHODS: A link to an online questionnaire was sent to 405 managers and regulatory professionals representing health technology enterprises in Finland. The study included 74 respondents. Descriptive statistics were used to describe and summarise the characteristics of the dataset. RESULTS: Information related to the MDR was fragmented and the necessary information was sought from multiple information sources, while the Finnish Medicines Agency (Fimea) was regarded as the most important source of information and training provider. To some extent, the managers and regulatory professionals expressed their dissatisfaction with the performance of Fimea. The managers and regulatory professionals were not very familiar with the ICT systems provided by the EU. The size of an enterprise affected how many medical devices it manufactures and generally affected the views about the MDR. CONCLUSIONS: The managers and regulatory professionals understood the role of the MDR regarding the safety and transparency of medical devices. The available information regarding the MDR did not properly fit the needs of users and there seemed to be a gap in information quality. The managers and regulatory professionals had some difficulties understanding the available information. Based on our findings, we believe it is paramount to evaluate the challenges faced by Fimea and how it could improve its performance. To some extent, the MDR is regarded as a burden for smaller enterprises. It is important to highlight the benefits of ICT systems and to develop them to better meet the information needs of enterprises. BioMed Central 2023-03-30 /pmc/articles/PMC10062684/ /pubmed/36997978 http://dx.doi.org/10.1186/s12913-023-09316-8 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Huusko, Juhamatti Kinnunen, Ulla-Mari Saranto, Kaija Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals |
title | Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals |
title_full | Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals |
title_fullStr | Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals |
title_full_unstemmed | Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals |
title_short | Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals |
title_sort | medical device regulation (mdr) in health technology enterprises – perspectives of managers and regulatory professionals |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10062684/ https://www.ncbi.nlm.nih.gov/pubmed/36997978 http://dx.doi.org/10.1186/s12913-023-09316-8 |
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