Medical Polymer Products Branch of China Medical Device Industry Association(hereinafter referred to as the branch), a subordinate organization of the China Medical Device Industry Association. Since its establishment, the branch has actively played coordination and consulting services in the industry, and played the role of "bridge" and "link" between the government and members, safeguarding the legitimate rights and interests of the industry, and continuously promoting and improving the safety and effectiveness of my country's medical devices. Promote the healthy development of China's medical device industry.

European UnionThe implementation of the MDR regulation is more stringent for the regulation of the medical device industry, with provisions for product quality control, pre-market risk control and post-market supervision, and clarifying the responsibilities of manufacturers and other economic operators. The implementation of the new regulations is undoubtedly a great challenge. Medical device companies should understand the relevant requirements of the new regulations MDR as soon as possible to ensure the compliance of medical device products with the new regulations, and do a good job in replacing certificates or re-applying for CE certification in accordance with the requirements of the new regulations.

In order to let more enterprises in the branch knowMDR new requirements, to understand the changes that may have an impact on enterprises, to ensure the smooth implementation of MDR regulations, the branch will hold a special training course on EU medical device regulations in Changzhou City, Jiangsu Province from June 22 to 25, 2021. The meeting was presided over by Yu Haichao of Weigao Group, head of the branch's laws and regulations group. Secretary General Li Weiyang, head of the branch, also made a keynote speech on behalf of the branch.

Nanjing Shuangwei Biomedical Technology Co., Ltd. actively participated in this training, led by the company's quality director Yu Jianping,Technical General Counsel Hu Zhengfang, System Commissioner SamuelParticipated in the whole process of the activity, and shared our company's views on the second day of the activity.experience and understanding of MDR in QMS and clinical evaluation,System Commissioner Samuel againstThe relevant changes of QMS under MDR are explained. According to the content sequence of Article 10 of the regulations, the documents that need to be added or changed according to the regulations and the corresponding contents are elaborated one by one on the preservation duration of relevant documents, PMS system, alert system, person in charge of regulations, design and development, post-listing supervision, etc. Division ITechnical General Counsel Hu Zhengfang TargetingThe clinical evaluation requirements of the new MDR regulations are interpreted, introducing the regulatory background related to the clinical requirements of MDR, the major changes in the clinical requirements of MDR compared with MDD, the clinical requirements of MDR, how to incorporate the MDR88 provisions into the requirements of PMS, MDR adverse events and on-site safety corrective measures reporting, and the terms and changes of the fourth edition of MedDev2.7.1 Clinical Evaluation Guidelines and the comparison with the clinical evaluation requirements of MDR, the ISO The standard changes and provisions of the 14155-2020 Medical Device Clinical Trial Management Code are also interpreted, and the MDCG guidelines related to the implementation of clinical requirements have been published by the European Union, including the MDCG 2021-5 Medical Device Standardization Guide, MDCG 2021-6 Questions and Answers on MDR Clinical Research, MDCG 2020-13 Clinical Evaluation Assessment Report Template, MDCG. 2020-6 Regulation (EU) 2017/745: Clinical Evidence Required for CE Medical Devices Previously Marked under Directives 93/42/EEC or 90/385/EEC, MDCG 2020-5 Clinical Evaluation of Medical Devices-Equivalence Guide, MDCG 2021-8 Clinical Study Application/Notification Document, MDCG 2020-10/1 Clinical Study Safety Reporting Guidelines, MDCG 2020-10/2 Annexes: Clinical Study Safety Summary Report Form, MDCG 2019-9 Safety and Clinical Performance Summary Guide, MDCG 2020-7 Post-Market Clinical Tracking (PMCF) Plan Template Guide, MDCG 2020-8 Post-Market Clinical Tracking (PMCF) Evaluation Report Template Guide, MDCG 2020-1 Medical Device Software Clinical Evaluation (MDR) Performance Evaluation (IVDR) Guide, and combined with the actual introduction of CE clinical evaluation of common review opinions and common problems..

In this training, we also carefully studied the sharing brought by other branch units, including 《CE Certification Application Process "comes from" Requirements for MDR Technical Documents "shared by Wuhan Zhixun Chuangyuan Technology Development Co., Ltd.," ISO 14971 under MDR: Risk Management and Availability of 2019 Medical Devices "shared by Tianjin Hana Good Medical Materials Co., Ltd., and" Assessment and Testing in Risk Management Process of Biological Evaluation of Medical Devices "shared by Weihai Desheng Technology Testing Co., Ltd. From the" Unique Identification of Medical Devices (UDI) Regulations and Practice Sharing in Europe, America and China "shared by Suzhou Linhua Medical Devices Co., Ltd., and the" Requirements for Clinical Evaluation and Post-marketing Activities under MDR "shared by Zhoutong Health Technology (Shanghai) Co., Ltd., a professional consulting company for medical devices. Through this training, we have gained a lot, and Sunway is also preparing for the full implementation of MDR.

Written by: Graham

typesetting: shi jun