Background: Prevention of Congenital Anomalies requires knowledge of risks and underlying causes. The data on malformation risks related to assisted reproduction, especially after IntraCytoplasmic Sperm Injection (ICSI), are still in discussion and not yet finally evaluated. In Germany ICSI is covered since July 1, 2002 by the Public Health Insurance, according to a decision by Federal Social Court (Bundessozialgericht)nevertheless a final assessment of this reproductive health technology will have to be taken until 2005. Objective: Stakeholders in Statutory Health Care, i.e. the National Board of Medical Doctors and Health Care Insurance, are asked to establish a procedure of quality assurance to especially regulate this method of assisted reproduction (ICSI). Methods: In order to offer an appropriate proposal we screened international literature. Results: Suitable for comparison, if treatment is carried out under equivalent circumstances and complete standardized data are collected. In this context EUROCAT definitions make an important and valuable contribution. Foreign examples show, that carefully designed registries help to bring about an effective assessment of reproductive health technology. Institution based data aggregation enables benchmarking as a means of quality improvement. Conclusion: Based on this analysis a proposal for a national registration system has been worked out, including the quality indicators multiple pregnancy and malformation rate. Both join existing documentation and may be presented in a flow-chart. The diagram showing registrational links necessary to cover factors influencing malformation rate during an ICSI-treatment will be commented in detail.