title: Clinical evaluation of medical devices: main constraints and           specificities.
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.
authors.affiliation: Foch Hospital, Suresnes, France.
authors.forename: François
authors.initials: F
authors.lastname: Parquin
authors.forename: Antoine
authors.initials: A
authors.lastname: Audry