General Safety and Performance Requirements--XX 产品GSPR安全和性能基本要求检查表 MDR.docxVIP

GENERAL SAFETY AND PERFORMANCE REQUIREMENTS Confidentiality: This document contains information that is confidential and proprietary property of Micro-Tech (Nanjing) CO., Ltd. Neither this document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party without prior written consent of Micro-Tech (Nanjing) CO., Ltd. Page PAGE 2 of 61 Confidentiality: This document contains information that is confidential and proprietary property of Micro-Tech (Nanjing) CO., Ltd. Neither this document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party without prior written consent of Micro-Tech (Nanjing) CO., Ltd. General Safety and Performance Requirements of XXX Document: XXX Rev: A/0 General Safety and Performance Requirements of XXX 受控状态 Status 版本 Version A/0 职能 Position 签字 Signature 日期 Date 编制 Draft 设计工程师 Design Engineer 审核 Review 批准 Approval 批准 Approval Confidentiality: PAGE 59 / 60 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS (xxx Rev: A/0) Confidentiality: PAGE \* Arabic 60 /60 Purpose This document is to provide the evidence that XXX is compliance with the general safety and performance requirements of Medical Device Regulation (EU) 2017/745. Please see the below table for details. Requirements A/NA Justification Relevant Standards Document, Report, Procedures Method General Requirements Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with