Phase I MDR Training Camp for New EU Regulations Held in Shanghai

  • 2021-03-30
On March 26, initialized by China Association for Medical Devices Industry and co-sponsored by TÜV Rheinland and RDS Testing, the "MDR Training Camp for New EU Regulations" was held as scheduled, where RDS Testing shared with the enterprise audience the regulatory requirements and verification practice on the reprocessing of reusable medical devices.

Wu Yinglong, Deputy Office Director of China Association for Medical Devices Industry, delivered a speech for the event. He said: "the new version of MDR regulations has put forward stricter requirements for the entire life cycle of medical device products, including design and development, clinical trials, product quality and post marketing regulation, which brings sizable challenges for domestic enterprises to obtain CE certification and enter the European market. In this regard, CAMDI will organize a series of special training camps for EU new laws and regulations with relevant institutions, hoping to bring insight to Chinese medical device enterprises through regulation interpretation and best practice application."

As ISO 17664:2017 is the requirement for medical device manufacturers to provide reprocessing information in the user's manual, the specific methods of cleaning, disinfection and sterilization have not been elaborated in this standard. Therefore, what additional regulations and standards need to be referred to? Which testing method should be used? What application scenarios and possible risks need to be considered? What kind of verification results will be determined as failure? In addition, what information should be included in the report submitted to the notified body? We have shared these questions with the enterprise representatives participating in this seminar.

As a local laboratory in China, RDS Testing has obtained the accreditation of IAS (International Accreditation Service) in the United States. The company founder Mr. Cha Shihong has been engaged in the field of disinfection and sterilization equipment for more than 20 years. As a member of the National Technical Committee on Sterilization Techniques and Equipment of Standardization Administration of China, and a member of the Disinfection Techniques and Application Special Committee of China Health Inspection Association, he is committed to providing more effective and comprehensive disinfection and sterilization solutions for medical device industry in China. 插入图片

In accordance with ISO 17664:2017, the laboratory carries out validation and testing service for cleaning, disinfection and sterilization methods, and ensures that the actual conditions of European hospitals and the special requirements of EU member states are fully considered in the testing and validation process. For example, alkaline detergent (KRINKO/BfArM of Germany) is commonly used in European hospitals, and all equipment for cleaning, disinfection and sterilization in the laboratory all pass ISO15883, EN13060, EN285 and other standards.
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