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, Candice Houg, Thomas Lihoreau, Thomas Lihoreau, Martina Hennessy, Helene Esperou, Rachel Benamore, Jean Palussiere, Lionel Pazart, Lionel Pazart

2022

Abstract

The evolution of technological innovations and medical devices requires particular reflections in terms of regulation. In order to harmonise practices between European countries and to reinforce clinical investigations, the European Regulation on medical devices 2017/745 has come to give a regulatory framework to the world of devices. A summary of the regulatory approaches for a clinical investigation of a new class III device conducted in France, Ireland and England is proposed in this article to illustrate the complexity of the processes, ending with an example. This illustrates the impact of the EU regulation and Brexit on the conduct of clinical investigations.

Paper Citation

in Harvard Style

Houg C., Lihoreau T., Hennessy M., Esperou H., Benamore R., Palussiere J. and Pazart L. (2022). 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 Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed, ISBN 978-989-758-552-4, pages 250-258. DOI: 10.5220/0010968600003123

in Bibtex Style

@conference{clinmed22,
author={Candice Houg and Thomas Lihoreau and Martina Hennessy and Helene Esperou and Rachel Benamore and Jean Palussiere and Lionel Pazart},
title={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},
booktitle={Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,},
year={2022},
pages={250-258},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010968600003123},
isbn={978-989-758-552-4},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,
TI - 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
SN - 978-989-758-552-4
AU - Houg C.
AU - Lihoreau T.
AU - Hennessy M.
AU - Esperou H.
AU - Benamore R.
AU - Palussiere J.
AU - Pazart L.
PY - 2022
SP - 250
EP - 258
DO - 10.5220/0010968600003123