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

Jacqueline Beddoe-Rosendo,Clare L Heaysman,Joseph V Hajnal,Sebastien Ourselin,Anne Vanhoestenberghe

Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine（2023）

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摘要

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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关键词

Medical device regulation, MHRA, approved body capacity, innovation, UKCA marking

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