Clinical Evaluation of Medical Devices: Main Constraints and Specificities

¹ Foch Hospital, Suresnes, France
² Medtronic France SAS, Boulogne, France

Correspondence and offprints: François Parquin, Respiratory Intensive Care Unit, Foch Hospital, BP 36, 92151 Suresnes Cedex, France. Email: f.parquin@hopital-foch.org

Received: 20 March 2012
Accepted: 4 June 2012

Abstract

The purpose of the Giens round table no. 1 was to make proposals and recommendations regarding the clinical evaluation of medical devices.

First, the European and French regulatory rules were examined and compared with the US FDA approach. Thereafter, the main specificities and constraints of the MD sector were underlined and their impact in clinical evaluation described and analyzed. Two areas, cumulating most of these constraints, were consecutively analyzed for concrete case study. Considering a patient-centered approach, the RT issued eight recommendations directed to manufacturers, physicians and policymakers in order to improve clinical evaluation in the medical device field.