Threats and Opportunities for the Clinical Investigation of High-risk Medical Devices in the Context of the New European Regulations

L. Pazart, L. Pazart, S. Pelayo, S. Pelayo, T. Chevallier, T. Chevallier, G. Gruionu, G. Gruionu, P. Mabo, P. Mabo, Y. Bayon, F. Barbot, F. Barbot, T. Lihoreau, T. Lihoreau, C. Roussel, C. Roussel, N. Maglaveras, E. Lekka, H. A. Ferreira, I. Rocha, L. Geris, C. Lavet

2021

Abstract

This position paper analyses the threats from the current situation of the clinical investigation to the expectations of the new European regulations focusing on high risk medical devices (HRMDs). We present also some opportunities to improve the feasibility and quality of clinical investigation. In summary, investigation protocols of medical devices, advised and authorized by the competent authorities, are few and heterogenous. There is a lack of quality in the existing studies, a lack of methodological knowledge and consequently high expectations for assistance from those involved in the design of clinical study protocols on HRMD. Guidance that is specific to the different type of devices is missing. Adaptive designs, pragmatic trial, usability methods, computer modeling and real world data are gaining more and more traction for assessing the safety and performance of high risk medical devices from a regulatory view-point.

Paper Citation

in Harvard Style

Pazart L., Pelayo S., Chevallier T., Gruionu G., Mabo P., Bayon Y., Barbot F., Lihoreau T., Roussel C., Maglaveras N., Lekka E., Ferreira H., Rocha I., Geris L. and Lavet C. (2021). Threats and Opportunities for the Clinical Investigation of High-risk Medical Devices in the Context of the New European Regulations.In Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed, ISBN 978-989-758-490-9, pages 274-284. DOI: 10.5220/0010382902740284

in Bibtex Style

@conference{clinmed21,
author={L. Pazart and S. Pelayo and T. Chevallier and G. Gruionu and P. Mabo and Y. Bayon and F. Barbot and T. Lihoreau and C. Roussel and N. Maglaveras and E. Lekka and H. Ferreira and I. Rocha and L. Geris and C. Lavet},
title={Threats and Opportunities for the Clinical Investigation of High-risk Medical Devices in the Context of the New European Regulations},
booktitle={Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,},
year={2021},
pages={274-284},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010382902740284},
isbn={978-989-758-490-9},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,
TI - Threats and Opportunities for the Clinical Investigation of High-risk Medical Devices in the Context of the New European Regulations
SN - 978-989-758-490-9
AU - Pazart L.
AU - Pelayo S.
AU - Chevallier T.
AU - Gruionu G.
AU - Mabo P.
AU - Bayon Y.
AU - Barbot F.
AU - Lihoreau T.
AU - Roussel C.
AU - Maglaveras N.
AU - Lekka E.
AU - Ferreira H.
AU - Rocha I.
AU - Geris L.
AU - Lavet C.
PY - 2021
SP - 274
EP - 284
DO - 10.5220/0010382902740284