As the world’s second-largest manufacturer and consumer of medical devices, the EU has a long history and substantial experience in the management of medical devices. In the early 1990s, EU countries, represented by the UK, France, and Germany, preliminarily formed their own medical device management systems. These included the British GMP requirements and adverse event reporting system, French clinical trial requirements, and German drug law and medical device safety regulations. With the announcement of the EU Single Market Treaty, the unified and coordinated European Medical Devices Directive (MDD) was officially released in 1993. Its purpose was to remove trade barriers, obtain mutual recognition, and perform technical coordination among EU member states. The MDD is one of the most important legislative tools of the EU, and its purpose is to ensure the consistency of laws within the EU. As a part of the unified market plan, the MDD has formulated a unified regulatory system for the management of medical devices in the EU, which is composed of three main directives: the Active Implantable Medical Devices Directive, the Medical Devices Directive, and the In Vitro Diagnostic Directive. The MDD is also the most influential medical device regulation thus far. It has been implemented in all EU member states and has achieved good results. This directive is hailed as a model that reflects the global unification of medical device regulations. The MDD introduced the following important concepts and requirements. Medical devices are divided into four categories according to the classification rules and follow different compliance review pathways. The MDD proposed the management of drug-device combination products, and basic requirements to ensure basic conditions for the safety and performance of medical devices were proposed and are used in cooperation with medical device standards to detail the technical indicators of the products. The MDD also includes the requirements for assessing the risk of medical devices and the requirements for clinical data related to the safety and effectiveness of medical devices. The MDD elucidated the obligation of manufacturers to report adverse events and test their marketed medical devices, proposed the concept of a third-party review agency, and implemented decentralized management (Ministry of Commerce of the People’s Republic of China 2015).