Comparison of approval procedures for medical devices in Europe and the USA

Abstract

Abstract Important achievements such as the discovery of penicillin increased life expectancy in the 19th century. At the beginning of the 20th century, the influence of technical equipment and biomedical research led to a further leap in life expectancy. The use of computer devices with sophisticated software also improved the quality of life. This is linked to the fact that all these achievements have now led to the emergence of one of the largest import and export markets in the USA, alongside the european union (EU), which is an association of European states. In order to guarantee a uniform quality of this abundance of different products and therapies, there are worldwide corresponding regulations, to which all manufacturers must adhere. The entry into force of these regulations, with the associated approval and testing obligations for each individual medical device, ensures that a consistently high quality of products is used on patients. Of course, high quality as well as high functionality and safety levels of medical products are a must. However, the implementation of these regulations is realized differently in the various markets, as there is no global harmonization. This work focuses on approval procedures for medical devices in Europe (EU) and the USA and compares significant differences in the approval procedures, which are shown as a graphical comparison. An example is an approval of medical devices by the U.S. Food and Drug Administration (FDA), which is an US government agency. In Europe (EU) there is a manufacturer’s declaration of conformity for the approval.