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...

Descripción completa

Detalles Bibliográficos
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
Descripción
Sumario: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.

Ejemplares similares