Regulatory measures for implementing new medical devices. Recalling Boneloc (R)

Through the past decades, new medical devices have been introduced at an increasing pace at the urge primarily of manufacturers, clinicians, and patients. Whereas it is mandatory to assess and approve new pharmaceuticals before their widespread use is allowed, innovations in medical devices generally have not been subject to the smae restrictions. The European Communitys program on completion of the Internal Market has generated a series of three Directives regulating the safety, reliability, and marketing of practically all non-pharmaceutical medical products. Once CE-marked, devices are available throughout the Union, an area constitued of nearly half a billion citizens after the expansion to 25 Member States. Before the European Union Directives were implemented, Bonelec (R) was introduced to commercial distribution in the beginning of the nineties as a new and promising bone cement to be utilized in joint arthroplasty prostheses. While promptly gaining wide acceptance in most of the Nordic countries, Bonelec (R) was after few years about 5,500 implanted Scandinavian patients withdrawn from the market abruptly because of inferior fixation properties. Utilizing Boneloc (R) as a test case, the present study critically examined whether a comparable incident could occur after the implementation of the European Union Directives and what strategies can be applied to avoid equivalent future misconduct.