Medical device regulatory challenges in the UK are affecting innovation and its potential benefits

The increase in regulatory challenges on medical technology developed and deployed in the UK is having a negative impact on innovation. In this paper we show how the limited capacity of Approved and Notified Bodies is one more barrier in the innovation pipeline, that could push more teams to conside...

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Autores principales: Beddoe-Rosendo, Jacqueline, Heaysman, Clare L, Hajnal, Joseph V, Ourselin, Sebastien, Vanhoestenberghe, Anne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2023
Materias:
Original Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10685680/
https://www.ncbi.nlm.nih.gov/pubmed/37840272
http://dx.doi.org/10.1177/09544119231203776
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author Beddoe-Rosendo, Jacqueline
Heaysman, Clare L
Hajnal, Joseph V
Ourselin, Sebastien
Vanhoestenberghe, Anne
author_facet Beddoe-Rosendo, Jacqueline
Heaysman, Clare L
Hajnal, Joseph V
Ourselin, Sebastien
Vanhoestenberghe, Anne
author_sort Beddoe-Rosendo, Jacqueline
collection PubMed
description The increase in regulatory challenges on medical technology developed and deployed in the UK is having a negative impact on innovation. In this paper we show how the limited capacity of Approved and Notified Bodies is one more barrier in the innovation pipeline, that could push more teams to consider applying for FDA approval instead of UKCA marking, potentially limiting how much our patients benefit from the world-leading research undertaken in UK universities.
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spelling pubmed-106856802023-11-30 Medical device regulatory challenges in the UK are affecting innovation and its potential benefits Beddoe-Rosendo, Jacqueline Heaysman, Clare L Hajnal, Joseph V Ourselin, Sebastien Vanhoestenberghe, Anne Proc Inst Mech Eng H Original Articles The increase in regulatory challenges on medical technology developed and deployed in the UK is having a negative impact on innovation. In this paper we show how the limited capacity of Approved and Notified Bodies is one more barrier in the innovation pipeline, that could push more teams to consider applying for FDA approval instead of UKCA marking, potentially limiting how much our patients benefit from the world-leading research undertaken in UK universities. SAGE Publications 2023-10-15 2023-11 /pmc/articles/PMC10685680/ /pubmed/37840272 http://dx.doi.org/10.1177/09544119231203776 Text en © IMechE 2023 https://creativecommons.org/licenses/by/4.0/This article is distributed under the terms of the Creative Commons Attribution 4.0 Lficense (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Articles
Beddoe-Rosendo, Jacqueline
Heaysman, Clare L
Hajnal, Joseph V
Ourselin, Sebastien
Vanhoestenberghe, Anne
Medical device regulatory challenges in the UK are affecting innovation and its potential benefits
title Medical device regulatory challenges in the UK are affecting innovation and its potential benefits
title_full Medical device regulatory challenges in the UK are affecting innovation and its potential benefits
title_fullStr Medical device regulatory challenges in the UK are affecting innovation and its potential benefits
title_full_unstemmed Medical device regulatory challenges in the UK are affecting innovation and its potential benefits
title_short Medical device regulatory challenges in the UK are affecting innovation and its potential benefits
title_sort medical device regulatory challenges in the uk are affecting innovation and its potential benefits
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10685680/
https://www.ncbi.nlm.nih.gov/pubmed/37840272
http://dx.doi.org/10.1177/09544119231203776
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