Analysis of Impact of European Medical Device Regulation and Brexit on the Regulatory Approaches in a Clinical Investigation Study on a New Class III Medical Devices Conducted in Europe and United Kingdom

Candice Houg, Thomas Lihoreau, Martina Hennessy, Helene Esperou, Rachel Benamore, Jean Palussiere, Lionel Pazart. Analysis of Impact of European Medical Device Regulation and Brexit on the Regulatory Approaches in a Clinical Investigation Study on a New Class III Medical Devices Conducted in Europe and United Kingdom. In Ana C. A. Roque, Ana L. N. Fred, Hugo Gamboa, editors, Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies, BIOSTEC 2022, Volume 1: BIODEVICES, Online Streaming, February 9-11, 2022. pages 250-258, SCITEPRESS, 2022. [doi]

Abstract

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