1, MDR (MedicalDeviceRegulation) is a medical device regulation issued by the European Union, the production, sale and use of medical devices have detailed provisions. While the domestic medical device regulation is "Medical Device Supervision and Administration Regulations", the two legal systems and executive agencies are different.
2. In terms of the design and development process, MDR puts forward more stringent requirements on the research and development, design, testing and evaluation of medical devices, requiring companies to conduct more comprehensive and systematic risk assessment and ensure the safety and effectiveness of medical devices.