title: New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues.
abstract: We describe here recent modifications to the French Coverage with Evidence Development (CED) scheme for innovative medical devices. CED can be defined as temporary coverage for a novel health product during collection of the additional evidence required to determine whether definitive coverage is possible. The principle refinements to the scheme include a more precise definition of what may be considered an innovative product, the possibility for device manufacturers to request CED either independently or in partnership with hospitals, and the establishment of processing deadlines for health authorities. In the long term, these modifications may increase the number of applications to the CED scheme, which could lead to unsustainable funding for future projects. It will also be necessary to ensure that the study conditions required by national health authorities are suitable for medical devices and that processing deadlines are met for the scheme to be fully operational. Overall, the modifications recently applied to the French CED scheme for innovative medical devices should increase the transparency of the process, and therefore be more appealing to medical device manufacturers.
authors.affiliation: Pharmacy Department, Georges Pompidou European Hospital, Paris, France; Faculty of Pharmacy, University Paris-Sud, Châtenay-Malabry, France. Electronic address: nicolas.martelli@egp.aphp.fr.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Martelli
authors.affiliation: Faculty of Pharmacy, University Paris-Sud, Châtenay-Malabry, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: van den Brink
authors.affiliation: Faculty of Pharmacy, University Paris-Sud, Châtenay-Malabry, France; Department of Health Economics, Gustave Roussy Institute, Villejuif, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Borget
mesh_terms: D018795:Device Approval; D005602:France; D006801:Humans; D013222:State Medicine / Q000458:organization & administration*; D013673:Technology Assessment, Biomedical / Q000379:methods*
keywords: coverage with evidence development; innovation; medical device; reimbursement