La dispensation pharmaceutique des dispositifs médicaux en France : état des lieux de la réglementation applicable

Abstract

The concept of medical device covers multiple products, multiple technologies, wide range of clinical applications and involves different actors in France in growing numbers sometimes with a monopoly. The French regulations are therefore often scattered while Community law is still developing. In this complex context, the French pharmacist however has a pivotal role. This role is well established since 1992 for the delivery of sterile medical devices in the hospital and was generally strengthened against the patient since 2002. In practice, pharmacists are faced with different situations that call into question the scope of their practice and responsibility. In the absence in France of “good dispensing practices” as they exist for preparations or fabrications, this article provides an overview of the current regulatory dispensation concerning medical devices. This review aims to provide answers to regulatory pharmacists facing atypical situations or recent changes in their professional practices.