[Risk analysis of medical products. Implementation of risk analysis exemplified by the spongiosa cannulated screw]

The Medical Devices Act (Medizinproduktegesetz = MPG) took effect in Germany on 01. 01. 1995, and replaced (with the exception of diagnostic laboratory devices) the previously binding MedGV with a transition period ending on 13. 06. 1998. The new German act is the implementation of the EC directive on active implantable medical devices (90/385/EWG) and the directive on medical devices (93/42/EWG). The EC directive 93/42/EWG on medical devices permits the manufacturer of a medical device to chose the conformity assessment procedure. All medical devices are subject to conformity assessment procedures, and are awarded the EC mark through Appendix II, III, VII or VIII. All these appendices contain information about the need for carrying out assessment and the obligation to provide a written description of the risk analysis for a medical device. Risk analysis is a common method that verifiably ensures that the basic requirements of EC Directive 93/42/EWG on medical devices are met by the product. It is obvious that risk analysis is of central importance to the legal measures for ensuring appropriate device safety. The present paper presents and assesses various methods of risk analysis.