上市后临床跟踪控制程序 文件编号： QP-29 版本：A/0 生效日期： 页码： 17 编制： 审核： 批准： 1. PURPOSE The purpose of this work instruction is to define the process to determine and document whether a post-market clinical follow-up study is required forTDI Foot/Ankle Array 8ch medical devices bearing the CE mark. The process will lead to a determination of whether a post-market clinical follow-up study is required and provide guidance for post-market clinical monitoring requirements if a study is not required. 2. SCOPE The work instruction applies to all medical device businesses and sites operating under the TDI Foot/Ankle Array 8ch Healthcare Quality Management System. Only medical devices bearing the CE Mark will be required to follow this work instruction. 3. REFERENCES 3.1. External References 3.1.1. Laws ▪ Council Directive 93/42/EEC of 14 June 1993 concerning medical devices including amendments through 05 September 2007 3.1.2. Guidance Documents ▪ European Commission Enterprise-Directorate-General MEDDEV 2.12-2 Guidelines on Post Market Clinical Follow-Up dated May 2004 ▪ MEDDEV 2.7.1 Rev.3 guidelines on medical device-clinical evaluation-a guide for manufacturers and notified bodies dated April 2009 ▪ GHTF Post-Market Clinical Follow-Up Studies; SG5(PD)N4R7 (Proposed document 23 July 2008) ▪ GHTF Clinical Investigations; SG5(PD)N3R7 (20 January 2008) 4. ROLES AND RESPONSIBILITIES Important: When a title of a position is listed in this work instruction, it relates to that position or its equivalent. Below are the roles and responsibilities discussed within this document. Table 4-1: Roles and Responsibilities Role Responsibility Design Engineering and/or Engineering Representative • Provide consultation to the...
