title: Post-approval studies in France, challenges facing medical devices.
abstract: Medical devices are characterized notably by a wide heterogeneity (from tongue depressors to hip prostheses, and from non-implantable to invasive devices), a short life cycle with recurrent incremental innovations (from 18 months to 5 years), and an operator-dependent nature. The objective of the current round table was to develop proposals and recommendations concerning the prerequisites needed in order to meet the French health authorities expectations concerning requests for post-approval studies for medical devices, required in cases where short and long-term consequences are unknown. These studies, which are the responsibility of the manufacturer or the distributor of the medical device, are designed to confirm the role of the medical device in the therapeutic management strategy in a real-life setting. There are currently approximately 150 post-approval studies underway, mainly concerning class III devices, and the majority face difficulties implementing the study or meeting the study objectives. In light of this, the round table endeavored to clearly identify the conditions for implementation of post-approval studies specific to the characteristics of medical devices. Various areas of progress have been envisaged to improve the performance of these studies, and by consequence, the efficiency of reimbursement of medical devices by the national health insurance. These include providing manufacturers with the opportunity to better anticipate post-approval requirements, defining a study-specific primary objective, integrating a phase allowing dialogue between the manufacturer, the health authorities and the scientific committee, and increasing awareness and training of health professionals on the impact of post-approval clinical studies in terms of the reimbursement of medical devices by the national insurance.
authors.affiliation: Abbott Vascular, Rungis, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Levesque
authors.affiliation: DGCIS, Service de l'industrie, Ivry sur Seine, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Coqueblin
authors.affiliation: CHU de Montpellier, Montpellier, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Guillot
authors.affiliation: LDR Medical, Rosières Près Troyes, France.
authors.forename: Lucie
authors.initials: L
authors.lastname: Aubourg
authors.affiliation: La-Ser, Paris, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Avouac
authors.affiliation: DGOS, Paris, France.
authors.forename: Cédric
authors.initials: C
authors.lastname: Carbonneil
authors.affiliation: UMR CNRS 5558, Service de pharmacologie, Lyon, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Cucherat
authors.affiliation: Direction générale de la santé, Paris, France.
authors.forename: Patricia
authors.initials: P
authors.lastname: Descamps-Mandine
authors.affiliation: WL Gore & Associés, Roquevaire, France.
authors.forename: Serge
authors.initials: S
authors.lastname: Hanoka
authors.affiliation: INSERM, Villejuif, France.
authors.forename: Marcel
authors.initials: M
authors.lastname: Goldberg
authors.affiliation: SNITEM, Courbevoie, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Josseran
authors.affiliation: Hôpital Foch, Suresnes, France.
authors.forename: François
authors.initials: F
authors.lastname: Parquin
authors.affiliation: Qualissima, Marseille, France.
authors.forename: Séverine
authors.initials: S
authors.lastname: Pitel
authors.affiliation: CNAMTS, Paris, France.
authors.forename: Christelle
authors.initials: C
authors.lastname: Ratignier
authors.affiliation: Direction de la recherche et de l'innovation, Toulouse, France.
authors.forename: Odile
authors.initials: O
authors.lastname: Sechoy
authors.affiliation: Johnson & Johnson, Issy les Moulineaux, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Szwarcenstein
authors.affiliation: Comité économique des produits de santé, Paris, France.
authors.forename: André
authors.initials: A
authors.lastname: Tanti
authors.affiliation: AP-HP, CHU Henri Mondor, Créteil, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Teiger
authors.affiliation: ANSM, Saint Denis, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Thevenet
mesh_terms: D020811:Biomedical Technology; D018795:Device Approval / Q000331:legislation & jurisprudence; D004867:Equipment Design; D004864:Equipment and Supplies / Q000191:economics; D005602:France; D006077:Government Agencies; D017408:Guidelines as Topic; D019981:Health Care Sector; D007349:Insurance, Health, Reimbursement; D007373:Interinstitutional Relations; D066192:Manufacturing Industry; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000639:trends