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*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)1243-1247
Number of pages5
JournalProceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine
Volume237
Issue number11
DOIs
Publication statusPublished - Nov 2023

Keywords

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

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