上市后临床跟踪管理程序文件

1.PURPOSEThe purpose of this work instruction is to define the process to determine anddocument whether a post-market clinical follow-up study is required forTDIFoot/Ankle Array 8ch medical devices bearing the CE mark. The process will leadto 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 notrequired.2.SCOPEThe work instruction applies to all medical device businesses and sites operatingunder the TDI Foot/Ankle Array 8ch Healthcare Quality Management System.Only medical devices bearing the CE Mark will be required to follow this workinstruction.3.REFERENCES3.1.External Referencesws▪Council Directive 93/42/EEC of 14 June 1993 concerning medical devices including amendments through 05 September 20073.1.2.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 RESPONSIBILITIESImportant: 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 ResponsibilitiesTable 4-1: Roles and Responsibilities5.WORK INSTRUCTIONPost-market clinical monitoring is an essential element in establishing long termsafety follow-up data and possible emergent risks for medical devices. These risks and data cannot adequately be detected and characterized by relying solely onpre-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 tomaintain 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 alsoprovide 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-UpPMCFSDetermination5.1.General Requirements5.1.1.Prior to M3 sign-off, the Product Regulatory Affairs Representative in consultationwith the Research Manager or designee and the Design Engineering and/orEngineering Representative shall determine for a given project/program whether a PMCFS is required. They shall also determine the post-market clinical follow-upplan.5.1.2. A PMCFS may not be required for products for which medium/long-term clinicalperformance 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-UpRequiredPost-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 ResearchManager or designee and Design Engineering and/or Engineering Representativeshall determine whether an equivalent device exists. Equivalence shall bedemonstrated 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 fluids5.2.2.Products for which the medium/long term clinical performance and safety is alreadyknown from previous use of the device, or from fully transferable experience withequivalent devices shall not require a PMCFS.NOTE:If the device quoted as the “equivalent” requires a PMCFS, then the newproduct shall be subject to the same requirement.5.2.3.The need for a PMCFS shall be determined based on the identification of residualrisks that may impact the risk/benefit ratio. A study should always be consideredfor devices where the identification of possible emerging risks and the evaluation of long term safety and performance are essential. The Product Regulatory AffairsRepresentative in consultation with the Research Manager or designee and DesignEngineering 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 largerpopulation;▪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 evidencemay be neede d for a particular device. Any risks identified as an “unacceptable”risk at the conclusion of the development process shall require a PMCFS. A studyshould also be considered for risks identified as “acceptable” or “risk mitigationrequired” if the dev ice meets any of the other characteristics identified in 5.2.1 and5.2.2. The risk assessment shall be performed according to the Risk ManagementProcedure. The Product Regulatory Affairs Representative shall review the riskassessment.5.2.5.The Product Regulatory Affairs Representative shall complete the Post MarketClinical Follow-Up Study Determination Form (Appendix A) once the decisionregarding 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-MarketClinical Follow-Up Plan (Appendix B) that details the plan for post-market clinicalfollow-up.5.2.7.The Research Manager or designee and Medical Affairs Representative shall reviewthe Post-Market Clinical Follow-Up Justification Form and The Post-Market ClinicalFollow-Up Plan to confirm the decisions regarding post-market clinical monitoring.5.3.No Post Market Clinical Follow-Up Study Required5.3.1.If it was determined that no PMCFS is required (based on section 5.2), post-marketclinical monitoring is still required for the medical device.5.3.2.Justification regarding the decision not to perform a PMCFS must be clearlydocumented 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 becompleted according to TDI Foot/Ankle Array 8ch established procedures/workinstructions. These elements will be inputs into the Post-Market LiteratureEvaluation 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 reviewshall be completed at the intervals specified in Table 5-1. The timing outlinedprovides the minimum requirements. The Product Regulatory AffairsRepresentative and/or the Research Manager or designee can determine thatclinical data shall be reviewed more often.Table 5-1: Timing for Review of Clinical Data based on Medical Device Class5.3.3.3.At the interval outlined in Table 5-1, the Research Manager or designee shallcomplete a literature review and analysis of post-market experiences (i.e.complaints and adverse events) and re-evaluate if a PMCFS needs to be conductedbased on this data. The Post Market Literature Evaluation and Market AnalysisConclusion form (Appendix D) shall be completed and maintained as part of thedevice’s design history/technical file. The Product Regulatory AffairsRepresentative and Medical Affairs Representative shall review and approve thisdocument.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 PostMarket Literature Evaluation and Market Experience Plan form (Appendix C)b.Instead of using The Literature Evaluation Report and Conclusion template, use thePost-Market Literature Evaluation and Market Analysis Report and Conclusion form(Appendix D)5.4.Post Market Clinical Follow-Up Study Required5.4.1.If it was determined that a PMCFS is required, in addition to the requirements listedunder 5.3.3, studies such as extended follow-up of patients enrolled in thepre-market trials, prospective study of a representative subset of patients after thedevice 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’sResearch Involving Human Subjects Procedure5.4.3.The Research Manager or designee in consultation with the Regulatory AffairsRepresentative and the Design Engineering and/or Engineering Representative willdetermine 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 available5.4.4.1.At the interval outlined in Table 5-1, the Research Manager or designee shallcomplete 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 Representativeshall 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 PostMarket Literature Evaluation and Market Experience Plan form (Appendix C)b.Instead of using The Literature Evaluation Report and Conclusion template, use thePost-Market Literature Evaluation and Market Analysis Report and Conclusion form(Appendix D)5.5.Elements of a post-market clinical follow-up study5.5.1.Post-market clinical follow-up studies are performed on a device within its intendeduse/purpose(s) according to the instructions for use.5.5.2. A PMCFS shall include the elements defined in the Writing Clinical InvestigationalPlans and Protocols Work Instruction.5.5.3.The objective(s) of a PMCFS should be stated clearly and should address the residualrisk(s) identified. It should be formulated to address one or more specificquestions 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 bescientifically 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 clinicalevidence to support the post-market surveillance program. This process may result in the need to reassess whether the device continues to comply with the EssentialPrinciples. Such assessments may result in corrective or preventive actions.6.APPENDIX6.1.Appendix A: Post-Market Clinical Follow-Up Study Determination6.2.Appendix B: Post-Market Clinical Follow-Up PlanExperience Analysis PlanAnalysis Report and Conclusion。