Post-approval Studies in France, Challenges Facing Medical Devices

¹ Abbott Vascular, Rungis, France
² DGCIS, Service de l’industrie, Ivry sur Seine, France
³ CHU de Montpellier, Montpellier, France
⁴ LDR Medical, Rosières Près Troyes, France
⁵ La-Ser, Paris, France
⁶ DGOS, Paris, France
⁷ UMR CNRS 5558, Service de pharmacologie, Lyon, France
⁸ Direction générale de la santé, Paris, France
⁹ WL Gore & Associés, Roquevaire, France
¹⁰ INSERM, Villejuif, France
¹¹ SNITEM, Courbevoie, France
¹² Hôpital Foch, Suresnes, France
¹³ Qualissima, Marseille, France
¹⁴ CNAMTS, Paris, France
¹⁵ Direction de la recherche et de l’innovation, Toulouse, France
¹⁶ Johnson & Johnson, Issy les Moulineaux, France
¹⁷ Comité économique des produits de santé, Paris, France
¹⁸ AP-HP, CHU Henri Mondor, Créteil, France
¹⁹ ANSM, Saint Denis, France

Correspondence and offprints: Karine Levesque, Abbott Vascular, 3 place Gustave Eiffel, 94518 Rungis, France. E-mail: karine.levesque@av.abbott.com

Received: 10 June 2014
Accepted: 12 June 2014

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.