Conformity Assessment in Germany

Abstract

The present study was mandated by the Federal Ministry of Economics in 2004 with the objective of drawing up options for a future conformity assessment structure in Germany. It was motivated by the need to gain an overview of the use of conformity assessment in Germany and of its institutional structures, which appeared to be rather fragmented on the level of accreditation and designation. The wish to improve the transparency and the effectiveness of the national conformity assessment system coincided with the efforts at the European level to enhance the implementation of the New Approach directives. Against this background, this study aimed to develop options which would accommodate the European and international guidelines, satisfy the interest of enterprises in economic and effective conformity assessment and take the concerns of the state into consideration in those areas in which conformity assessment was used in a regulatory context. To this end, it was necessary to illustrate the structure of the current system and present the requirements from legal provisions and standards, in particular those of European and international origin.Thus, the study outlines the foundations of the phenomenon of conformity assessment (first part, first section) and identifies their European and international context (first part, second section). An essential component of the structural analysis was the study of conformity assessment and accreditation in other European countries (first part, third section). From this the study has gained key insights for the evaluation of the German conformity assessment system, the current state of which will be described in the fourth section. Against this background, the advisory opinion in the second part reaches conclusions and recommendations.The study is based on the analysis of the applicable legal foundations in European and national law, which takes the state of affairs up to 1 March, 2006 into consideration to the greatest possible extent. Furthermore, official documents and other information from the involved actors were analyzed. Particularly fruitful were the talks and interviews with representatives of the responsible ministries, the accreditation bodies and conformity assessment bodies abroad conducted between October and December 2004 and with representatives of the German conformity assessment system conducted in 2005. The former resulted in a short description of the respective conformity assessment and accreditation structures in France, the Netherlands, Austria, Sweden, Switzerland and the United Kingdom which is enclosed in the Appendix. It reflects the state of discussions at the end of the year 2004, i.e. in a rather early phase of the discussion process at the European level. Nevertheless, the description of the legal foundations and the institutional standards should still be valid so that the country reports might still be of interest.Meanwhile, the review process at the European level has led to the adoption of two horizontal legal acts, Regulation No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products, and Decision No 768/2008/EC on a common framework for the marketing of products. As the study had been completed in April 2006, it was only possible to take into consideration the results reached up to then. For the English version, references to the horizontal legal provisions in the Second Part of the study have been updated on the basis of the Regulation and the Decision adopted in July 2008. In Germany, efforts are undertaken to restructure the fragmented accreditation system.