For a long time, there have been extensive requirements that manufacturers in the EU had to meet. These requirements are now specified in more detail and extend across the entire medical device supply chain. Systems for risk management, vigilance and post-market surveillance must be implemented and interlinked as integral parts of the overall quality management. The resulting information must be systematically analyzed by the manufacturer and documented in periodic reports to continuously update the technical documentation and support a reliable risk assessment. Individuals entrusted with conducting clinical evaluations must demonstrate a high level of technical expertise. In addition, manufacturers must employ a specific person who is responsible for monitoring compliance with regulatory requirements. Furthermore, manufacturers are required to maintain liability insurance for the financial coverage of any damage that may be caused by defective products.