上市后临床跟踪管理程序.doc

上市后临床跟踪控制程序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 RoleResponsibility Design Engineering and or Engineering Representative Provide consultation to the Product Regulatory Affairs Representative in determining for a given project product whether a post market clinical follow up study is required Provide consultation to the Product Regulatory Affairs Representative to determine if an equivalent device exists Provide consultation to the Product Regulatory Affairs Representative in identifying emerging risks for the medical device Provide consultation to the Research Manager or designee to determine the type of post market clinical follow up study to be implemented if applicable Product Regulatory Affairs Representative Determine for a give project product whether a post market clinical follow up study is required Determine if an equivalent device exists Identify potential emerging risks Review risk assessment Complete the Post Market Clinical Follow Up Justification Form regarding decision to perform a study Complete the Post Market Clinical Follow Up Plan form that details the post market clinical follow up plan Determine how often clinical data must be reviewed Review and approve the clinical evaluation performed by the Research Manager or designee Regulatory Affairs Representative Provide consultation to the Research Manager to determine the type of post market clinical follow up study to be implemented if applicable Table 4 1 Roles and Responsibilities RoleResponsibility Research Manager or designee Provide consultation to the Product Regulatory Affairs Representative in determining for a given project product whether a post market clinical follow up study is required Provide consultation to the Product Regulatory Affairs Representative to determine if an equivalent device exists Provide consultation to the Product Regulatory Affairs Representative to identify potential emerging risks Review the Post Market Clinical Follow Up Justification form and Post Market Clinical Follow Up Plan form to confirm the decisions regarding the need for a post market clinical follow up study and clinical follow up Determine how often clinical data must be reviewed Determine the type of post market clinical follow up study to be implemented if applicable Review new data i e literature adverse events complaints etc and determine if a post market clinical follow up study is necessary based on new information clinical evaluation Medical Affairs Representative Review the Post Market Clinical Follow Up Justification form and Post Market Clinical Follow Up Plan form to confirm the decisions regarding the need for a post market clinical follow up study and clinical follow up Review and approve the clinical evaluation performed by the Research Manager or designee 5 WORK INSTRUCTION Post market clinical monitoring is an essential element in establishing long term safety follow up data and possible emergent risks for medical devices These risks and data cannot adequately be detected and characterized by relying solely on pre market clinical investigations Post market clinical monitoring may include a combination of several strategies Product complaint review Post market event reporting review of users and patients Literature review Post market clinical follow up studies PMCFS This work instruction was created to determine when a PMCFS is necessary to maintain an adequate post market surveillance system as required by the Medical Device Directive 93 42 ECC MDD as amended by MDD 2007 47 EC It will also provide guidance on the post market clinical monitoring requirements if a PMCFS is not required Figure 5 1 High Level Process Overview for Post Market Clinical Follow Up Determine whether an equivalent device exists Identify residual risks emerging risks Review Risk Assessment document Evaluate need for PMCFS PMCFS Required PMCFS Determination Perform PMCFS in accordance with GEHC GQP 10 03 and GEHC GQP 10 03 002 YES At a minimum review clinical data including AE s complaints and literature NO Review new data and determine the need to a PMCFS based on new information 5 1 General Requirements 5 1 1 Prior to M3 sign off the Product Regulatory Affairs Representative in consultation with the Research Manager or designee and the Design Engineering and or Engineering Representative shall determine for a given project program whether a PMCFS is required They shall also determine the post market clinical follow up plan 5 1 2 A PMCFS may not be required for products for which medium long term clinical performance and safety is already known from previous use of the device or where other appropriate post market surveillance activities would provide sufficient data to address the risks 5 2 Determining the Type of Post Market Clinical Follow Up Required Post market clinical monitoring shall have one of two outcomes 1 PMCFS required or 2 no PMCFS required The need for a PMCFS shall be based on a combination of several factors detailed in this section 5 2 1 The Product Regulatory Affairs Representative in consultation with the Research Manager or designee and Design Engineering and or Engineering Representative shall determine whether an equivalent device exists Equivalence shall be demonstrated in all the essential characteristics precisely defined below Equivalence means Clinical Used for the same clinical condition or purpose Used at the same site in the body Used in similar population including age anatomy physiology Have similar relevant critical performance according to expected clinical effect for specific intended use Technical Used under similar conditions of use Have similar specifications and properties Be of similar design Use similar deployment methods Have similar principles of operation Biological Same or similar use of materials in contact with human tissues or body fluids 5 2 2 Products for which the medium long term clinical performance and safety is already known from previous use of the device or from fully transferable experience with equivalent devices shall not require a PMCFS NOTE If the device quoted as the equivalent requires a PMCFS then the new product shall be subject to the same requirement 5 2 3 The need for a PMCFS shall be determined based on the identification of residual risks that may impact the risk benefit ratio A study should always be considered for devices where the identification of possible emerging risks and the evaluation of long term safety and performance are essential The Product Regulatory Affairs Representative in consultation with the Research Manager or designee and Design Engineering and or Engineering Representative shall identify such emerging risk the following criteria should be taken into account innovation e g where the design of the device the materials the principles of operation the technology or the medical indications are novel high risk anatomical locations i e heart central nervous system etc severity of disease treatment challenges sensitivity of target population i e infants children pregnant women etc identification of an acceptable risk during the pre CE clinical evaluation which should be monitored in a longer term and or through a larger population well known risks identified from the literature or similar marketed devices discrepancy between the pre market follow up time scales and the expected life of the product 5 2 4 A properly conducted risk analysis is essential in determining what clinical evidence may be needed for a particular device Any risks identified as an unacceptable risk at the conclusion of the development process shall require a PMCFS A study should also be considered for risks identified as acceptable or risk mitigation required if the device meets any of the other characteristics identified in 5 2 1 and 5 2 2 The risk assessment shall be performed according to the Risk Management Procedure The Product Regulatory Affairs Representative shall review the risk assessment 5 2 5 The Product Regulatory Affairs Representative shall complete the Post Market Clinical Follow Up Study Determination Form Appendix A once the decision regarding the need for a study has been determined NOTE This form may also be used as a guide in making the determination about the need to perform a PMCFS 5 2 6 The Product Regulatory Affairs Representative shall complete the Post Market Clinical Follow Up Plan Appendix B that details the plan for post market clinical follow up 5 2 7 The Research Manager or designee and Medical Affairs Representative shall review the Post Market Clinical Follow Up Justification Form and The Post Market Clinical Follow Up Plan to confirm the decisions regarding post market clinical monitoring 5 3 No Post Market Clinical Follow Up Study Required 5 3 1 If it was determined that no PMCFS is required based on section 5 2 post market clinical monitoring is still required for the medical device 5 3 2 Justification regarding the decision not to perform a PMCFS must be clearly documented and maintained in the design history technical file see 5 2 5 5 3 3 Post Market Clinical Monitoring Requirements minimum 5 3 3 1 At a minimum the following post market clinical monitoring activities shall be completed according to TDI Foot Ankle Array 8ch established procedures work instructions These elements will be inputs into the Post Market Literature Evaluation and Market Analysis Report Review of product complaints according to Complaint Handling Procedure Review of post market adverse events according to Post Market Event Reporting Procedure Literature review according to TDI Foot Ankle Array 8ch Evaluation of Clinical Data to Support CE Marking Work Instruction 5 3 3 2 Review of product complaints post market adverse events and the literature review shall be completed at the intervals specified in Table 5 1 The timing outlined provides the minimum requirements The Product Regulatory Affairs Representative and or the Research Manager or designee can determine that clinical data shall be reviewed more often Table 5 1 Timing for Review of Clinical Data based on Medical Device Class Device ClassificationTiming for review of clinical data minimum Class IAnnually Class IIa IIbAt a minimum annually should consider more often Class IIISemi annually i e twice a year should consider more often 5 3 3 3 At the interval outlined in Table 5 1 the Research Manager or designee shall complete a literature review and analysis of post market experiences i e complaints and adverse events and re evaluate if a PMCFS needs to be conducted based on this data The Post Market Literature Evaluation and Market Analysis Conclusion form Appendix D shall be completed and maintained as part of the device s design history technical file The Product Regulatory Affairs Representative and Medical Affairs Representative shall review and approve this document NOTE The literature review shall be executed according to the Evaluation of Clinical Data to Support CE Marking Work Instruction section 5 5 However the following forms templates shall be used in place of those specified in this work instruction a Instead of using The Literature Evaluation Plan template referenced use the Post Market Literature Evaluation and Market Experience Plan form Appendix C b Instead of using The Literature Evaluation Report and Conclusion template use the Post Market Literature Evaluation and Market Analysis Report and Conclusion form Appendix D 5 4 Post Market Clinical Follow Up Study Required 5 4 1 If it was determined that a PMCFS is required in addition to the requirements listed under 5 3 3 studies such as extended follow up of patients enrolled in the pre market trials prospective study of a representative subset of patients after the device is placed on the market or an open registry may be performed 5 4 2 The PMCFS shall be carried out in accordance with TDI Foot Ankle Array 8ch s Research Involving Human Subjects Procedure 5 4 3 The Research Manager or designee in consultation with the Regulatory Affairs Representative and the Design Engineering and or Engineering Representative will determine the type of PMCFS that will be implemented 5 4 4 The study should take into account the following Results of the clinical investigation including adverse events identified Average life expectancy of the device The claims made by the manufacturer for the device Performances for which equivalence is claimed New information becoming available 5 4 4 1 At the interval outlined in Table 5 1 the Research Manager or designee shall complete a literature review and analysis of post market experiences i e complaints and adverse events and review the ongoing results data of the PMCFS The Post Market Literature Evaluation and Market Analysis Conclusion form Appendix D shall be maintained as part of the device s design history technical file The Product Regulatory Affairs Representative and Medical Affairs Representative shall review and approve this document NOTE The literature review shall be executed according to the Evaluation of Clinical Data to Support CE Marking Work Instruction section 5 5 However the following forms templates shall be used in place of those specified in this work instruction a Instead of using The Literature Evaluation Plan template referenced use the Post Market Literature Evaluation and Market Experience Plan form Appendix C b Instead of using The Literature Evaluation Report and Conclusion template use the Post Market Literature Evaluation and Market Analysis Report and Conclusion form Appendix D 5 5 Elements of a post market clinical follow up study 5 5 1 Post market clinical follow up studies are performed on a device within its intended use purpose s according to the instructions for use 5 5 2 A PMCFS shall include the elements defined in the Writing Clinical Investigational Plans and Protocols Work Instruction 5 5 3 The objective s of a PMCFS should be stated clearly and should address the residual risk s identified It should be formulated to address one or more specific questions relating to the clinical safety or performance of the device 5 5 4 Post market clinical follow up studies should be designed to address the objective s of the study The design may vary based on the objective s and should be scientifically sound to allow for valid conclusions to be drawn 5 5 5 The study design can take several forms for example the extended follow up of patients enrolled in pre market investigations a new clinical investigation a review of data derived from a device registry a review of relevant retrospective data from patients previously exposed to the device the analysis plan including any interim reporting and procedures for early study termination 5 5 6 The data and conclusions derived from the PMCFS are used to provide clinical evidence to support the post market surveillance program This process may result in the need to reassess whether the device continues to comply with the Essential Principles Such assessments may result in corrective or preventive actions 6 APPENDIX 6 1 Appendix A Post Market Clinical Follow Up Study Determination XXXXXXX Healthcare XXXXXXX Device This form is used to document the rationale for determining the need for a post market clinical follow up study Once complete this form shall be saved as part of the device s technical file Section 1 Determine if the proposed equivalent device meets the requirements of equivalence as outlined in MEDDEV 2 7 1 There is no proposed equivalent device proceed to Section 2 Proposed equivalent device manufacturer device name Proposed equivalent device model number Questions 1 10 must be answered yes or n a in order for the proposed equivalent device to meet the definition of equivalent Clinical Equivalence 1 Is the proposed equivalent device used for the same clinical condition or purpose as the device Explain Yes No 2 Is the proposed equivalent device used at the same site in the body as the device Explain Yes No 3 Is the proposed equivalent device used in a similar population including age anatomy physiology as the XXXXXXX device Explain Yes No 4 Does the proposed equivalent device have similar relevant critical performance according to expected clinical effect for a specific intended use as the XXXXXXX device Explain Yes No Technical Equivalence 5 Is the proposed equivalent device used under similar conditions of use as the XXXXXXX product Explain Yes No 6 Does the proposed equivalent device have similar spe