TY - JOUR
T1 - Medical device regulatory challenges in the UK are affecting innovation and its potential benefits
AU - Beddoe-Rosendo, Jacqueline
AU - Heaysman, Clare L.
AU - Hajnal, Joseph V.
AU - Ourselin, Sebastien
AU - Vanhoestenberghe, Anne
N1 - Publisher Copyright:
© IMechE 2023.
PY - 2023/11
Y1 - 2023/11
N2 - 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.
AB - 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.
KW - approved body capacity
KW - innovation
KW - Medical device regulation
KW - MHRA
KW - UKCA marking
UR - http://www.scopus.com/inward/record.url?scp=85174274419&partnerID=8YFLogxK
U2 - 10.1177/09544119231203776
DO - 10.1177/09544119231203776
M3 - Article
C2 - 37840272
AN - SCOPUS:85174274419
SN - 0954-4119
VL - 237
SP - 1243
EP - 1247
JO - Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine
JF - Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine
IS - 11
ER -