PubMed

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

PMID: 37840272 · 2023-10-15

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ЖурналProceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine

Год2023-10-15

PMID37840272

Аннотация

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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