Experience with post-market surveillance of in-vitro diagnostic medical devices for lay use in Germany.

Background: The European Directive 98/79/EC on in-vitro diagnostic medical devices (IVDs) regulates IVD marketing practices and post-market surveillance. IVD manufacturers have to inform the responsible Competent Authorities of any issues. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is responsible for most IVDs, with a small subset of IVDs being within the responsibility of the Paul-Ehrlich-Institute (PEI). Methods: All IVD notifications received by BfArM between 1999 and June 2006 were analysed in terms of the source of notification, underlying product defects and corrective actions. Results: A total of 773 notifications were received, 566 related to IVDs for professional use and 207 related to over-the-counter (OTC) products for lay use. The latter included systems for blood glucose testing (analysers, tests and control materials; n=166) or coagulation testing (n=13) and pregnancy tests (n=25). Most reports came from manufacturers (n=115; 55.6%) and users (n=72; 34.8%) mainly via pharmacies and the Drug Commission of the German Pharmaceutical Association. Manufacturer investigations for all lay IVD cases reported revealed underlying product defects in 53 cases (25.6%). Product failure was excluded in 80 cases (38.6%), which included a large number of user errors (n=34). Many cases (n=74, 35.7%) could not be clarified because the test strips and/or analysers were not returned to the manufacturer for further investigation. In most cases, product defects identified by manufacturer investigations were related to the test strips and not to the analysers. Because of the high proportion of cases without proven product failure, corrective actions were performed only in a subset (n=54, 26.1%) of the cases reported for IVDs specified for lay use. Conclusions: The results show that the governmental system for post-marketing surveillance of IVDs is an established tool to ensure product safety. The proportion of notifications for OTC products indicates that they should be the focus for action by the competent surveillance authorities. Clin Chem Lab Med 2007;45:396–401. [ABSTRACT FROM AUTHOR]