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1、精品文档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：18编制：审核：批准：1. PURPOSEThe purpose of this work instruction is to define the process to determine and docume nt whether a post-market cli nical follow-up study is required forTDI Foot/A nkle Array 8ch medical devices beari ng the CE mark. The process will lead to
2、 a determ in ati on of whether a post-market cli nical follow-up study is required and provide guidance for post-market clinical monitoring requirements if a study is not required.2. SCOPEThe work in structi on applies to all medical device bus in esses and sites operat ing un der the TDI Foot/A nkl
3、e Array 8ch Healthcare Quality Man ageme nt System.Only medical devices bearing the CE Mark will be required to follow this work in structio n.3 REFERENCES3.1. External References3.1.1. LawsCouncil Directive 93/42/EEC of 14 June 1993 concerning medical devices in cludi ng ame ndme nts through 05 Sep
4、tember 20073.1.2. Guidance DocumentsEuropea n Commissi on En terprise-Directorate-Ge neral MEDDEV 2.12-2Guidelines on Post Market Clinical Follow-Up dated May 2004MEDDEV 2.7.1 Rev.3 guideli nes on medical device-cli ni cal evaluati on-a guide for manufacturers and no tified bodies dated April 2009GH
5、TF Post-Market Cli ni cal Follow-Up Studies; SG5(PD)N4R7 (Proposed docume nt 23 July 2008)GHTF Cli nical In vestigatio ns; SG5(PD)N3R7 (20 Jan uary 2008)4. ROLES AND RESPONSIBILITIESImportant: Whe n a title of a positi on is listed in this work in struct ion, it relates to that positi on or its equi
6、vale nt.Below are the roles and resp on sibilities discussed withi n this docume nt.Table 4-1: Roles and ResponsibilitiesRoleResponsibilityDesig n Engin eeri ng an d/or Engin eeri ng Represe ntative Provide con sultati on to the Product Regulatory Affairs Represe ntative in determ ining for a give n
7、 project/product whether a post-market cli nical follow-up study is required Provide con sultati on to the Product Regulatory Affairs Represe ntative to determ ine if an equivale nt device exists Provide con sultati on to the Product Regulatory Affairs Represe ntative in identifying emerging risks f
8、or the medical device Provide consultation to the Research Manager or desig nee to determine the type of post-market cli nical follow-up study to be impleme nted, if applicableProduct RegulatoryAffairs Represe ntative Determi ne for a give project/product whether a post-market cli ni cal follow-up s
9、tudy is required Determ ine if an equivale nt device exists Ide ntify pote ntial emerg ing risks Review risk assessme nt Complete the Post-Market Cli nical Follow-Up Justificati on Form regard ing decisi on to perform a study Complete the Post-Market Cli nical Follow-Up Plan form that details the po
10、st-market cli nical follow-up pla n Determ ine how often cli ni cal data must be reviewed Review and approve the cli nical evaluati on performed by the Research Manager or desig neeRegulatory AffairsReprese ntativeProvide con sultati on to the Research Man ager to determ ine the type ofpost-market c
11、linical follow-up study to be implemented, if applicableTable 4-1: Roles and ResponsibilitiesRoleResponsibilityResearch Man ager or desig nee Provide con sultati on to the Product Regulatory Affairs Represe ntative in determ ining for a give n project/product whether a post-market cli nical follow-u
12、p study is required Provide con sultati on to the Product Regulatory Affairs Represe ntative to determ ine if an equivale nt device exists Provide con sultati on to the Product Regulatory Affairs Represe ntative to identify potential emerging risks Review the Post-Market Cli ni cal Follow-Up Justifi
13、cati on 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 Determ ine how often cli ni cal data must be reviewed Determi ne the type of post-market cli ni cal follow-up study to be impleme nt
14、ed, if applicable Review new data (i.e. literature, adverse eve nts, compla in ts, etc,) and determine if a post-market clinical follow-up study is necessary based on new information (clinical evaluation)Medical AffairsReprese ntative Review the Post-Market Cli ni cal Follow-Up Justificati on form a
15、nd 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 cli nical evaluati on performed by the Research Manager or desig nee5. WORK INSTRUCTIONPost-market cli ni cal mon itori ng
16、is an esse ntial eleme nt in establish ng long term safety follow-up data and possible emerge nt risks for medical devices. These risks and data cannot adequately be detected and characterized by relying solely on pre-market cli ni cal in vestigati ons.Post market cli nical mon itori ng may in clude
17、 a comb in ati on of several strategies:Product compla int reviewPost-market eve nt report ing review of users and patie ntsLiterature reviewPost-market clinical follow-up studies (PMCFS)This work in structi on was created to determ ine whe n a PMCFS is n ecessary to main tai n an adequate post-mark
18、et surveilla nee system, as required by the Medical Device Directive 93/42/ECC (MDD) as amen ded by MDD 2007/47/EC. It will alsoprovide guidanee on the post-market clinical monitoring requirements if a PMCFS is not required.PMCFSDeter min ati onFigure 5-1: High-Level Process Overview for Post-Market
19、 Clinical Follow-Up5.1.General Requirements5.1.1.Prior to M3 sign-off, the Product Regulatory Affairs Representative in consultation with the Research Man ager or desig nee and the Desig n Engin eeri ng an d/or Engineering Representative shall determine for a given project/program whether a PMCFS is
20、 required. They shall also determine the post-market clinical follow-up pla n.5.1.2.A PMCFS may not be required for products for which medium/long-term clinical performa nee and safety is already known from previous use of the device or where other appropriate post-market surveillance activities wou
21、ld provide sufficient data to address the risks.5.2.5.2.1.5.2.2.5.2.3.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 seve
22、ral factors detailed in this section.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 essentia
23、l characteristics precisely defined below. Equivalence means:ClinicalUsed 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
24、specific intended useTechnicalUsed under similar conditions of use;Have similar specifications and properties;Be of similar design;Use similar deployment methodsHave similar principles of operationBiologicalSame or similar use of materials in contact with human tissues or body fluidsProducts for whi
25、ch 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 newproduct shall be subject to t
26、he same requirement.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 performanc
27、e are essential. The Product Regulatory AffairsRepresentative 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 th
28、e device, the materials, the principlesof 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.
29、);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 exp
30、ectedlife 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 consi
31、dered for risks identified as“ acceptable ” or “risk mitigatiorequired ” if the diceevmeets any of the other characteristics identified in 5.2.1 and5.2.2. The risk assessment shall be performed according to the Risk Management Procedure. The Product Regulatory Affairs Representative shall review the
32、 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 a
33、bout 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 t
34、he 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 Required5.3.1. If it was determined that no PMCFS is required (based on section 5.2), post-
35、market clinical monitoring is still required for the medical device.5.32 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 m
36、inimum, the following post-market clinical monitoring activities shall be completed accord ing to TDI Foot/A nkle Array 8ch established procedures/work in struct ions. These eleme nts will be in puts into the Post-Market Literature Evaluation and Market Analysis Report.Review of product compla ints
37、accordi ng to Compla int Han dli ng ProcedureReview of post market adverse eve nts accord ing to Post Market Event Report ing ProcedureLiterature review accordi ng to TDI Foot/A nkle Array 8ch Evaluati on of Clinical Data to Support CE Marking Work Instruction .5.3.3.2. Review of product complaints,
38、 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 requireme nts. The Product Regulatory Affairs Representative and/or the Research Manager or desig nee can determine thatcli ni cal data shall be
39、reviewed more ofte n.Table 5-1: Timing for Review of Clinical Data based on Medical Device ClassDevice ClassificationTiming for review of clinical data (minimum)Class IAnnu allyClass IIa, IIbAt a minimum annu ally, should con sider more ofte nClass IIISemi-a nnu ally (i.e. twice a year), should con
40、sider more ofte n5.3.3.3. At the interval outlined in Table 5-1, the Research Manager or desig nee shall complete a literature review and an alysis of post-market experie nces (i.e. complai nts and adverse eve nts) and re-evaluate if a PMCFS n eeds to be con ducted based on this data. The Post Marke
41、t Literature Evaluati on and Market An alysis Con clusi on form (Appe ndix D) shall be completed and maintained as part of the device ' s design history/technical file.The Product Regulatory Affairs Represe ntative and Medical Affairs Represe ntative shall review and approve this docume nt.NOTE:
42、 The literature review shall be executed accord ing to the Evaluati on of Cli nical Data to Support CE Marki ng Work In structi on, secti on 5.5. However, the followi ng forms/templates shall be used in place of those specified in this work in structi on:a. In stead of using The Literature Evaluati
43、on Pla n template refere need, use the PostMarket Literature Evaluati on and Market Experie nee Pla n form (Appe ndix 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
44、.4. Post Market Clinical Follow-Up Study Required5.4.1. 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
45、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 Procedure5.4.3. The Research Manager or designee in consultation with the Regulatory Affairs Representat
46、ive 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 identifiedAverage life expectancy of the deviceThe claims
47、made by the manufacturer for the devicePerformances for which equivalence is claimedNew information becoming available5.4.4.1. 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 adver
48、se 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/templatesshall b