1.
Proc Inst Mech Eng H
; 237(11): 1243-1247, 2023 Nov.
Artigo
em Inglês
| MEDLINE
| ID: mdl-37840272
RESUMO
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.