In total, more than 400.000 different medical devices are on the market worth approximately 200 bn EUR. With this huge volume it is after the drug market (about 351 bn EUR) one of the most important markets in Europe today. With about 170.000 employees and an aggregated turnover of 17.3 bn EUR in 2007 the German medical product market is the third biggest in the world (after USA and Japan). Despite their amount and significance there is, especially in Germany, still an insufficient legal structure for evaluating the cost benefit of new innovative products. Particularly in comparison to drugs, which are extensively evaluated in benefit as well as cost-effectiveness, medical device evaluation leads a shadowy existence.
The following work tries to compare the evaluation methods currently performed in Great Britain with the German approach and provides proposals for improvements. In order to embark this uneasy task the work describes the national as well as European regulation of medical devices, including the terminology as well as the system and structure of the German / UK system. It discusses the economic evaluation and focuses on the evaluation pathway programme of the National Institute of Clinical Excellence (NICE), including the QALY concept as well as a detailed case study. Within this chapter the work also analyses the efficiency frontier concept which is currently used by the German Institut für Qualitätssicherung und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) in order to evaluate the costs and benefits of drugs. The legal aspects of medical device evaluation such as the fairness problem, procedural issues and level of disclosure complete this work. The current law concerning the evaluation of drugs (Gesetz zur Neuordnung des Arzneimittelmarktes) illustrates the importance of cost-effectiveness measurement in the German health care sector.