上市后臨床跟蹤管理程序

1、1.PURPOSE上市后臨床跟蹤控制程序文件編號(hào)：QP-29版本：A/0生效日期：頁(yè)碼：17編制：審核：批準(zhǔn)：The purp ose of this work in structio n is to defi ne the pro cess to determ ine and docume nt whether a po st-market cli nical follow-u p study is required forTDI Foot/A nkle Array 8ch medical devices beari ng the CE mark. The pro cess will lea

2、d to a determ in ati on of whether a po st-market clin ical follow-u p study is required and p rovide guida nee for po st-market cli ni cal mon itori ng requireme nts if a study is not required.2.SCOPEThe work in structi on app lies to all medical device bus in esses and sites op erat ing un der the

3、 TDI Foot/A nkle Array 8ch Healthcare Quality Man ageme nt System.On ly medical devices beari ng the CE Mark will be required to follow this work in structio n.3.REFERENCES3.1.Exter nal Refere nces3.1.1.LawsCouncil Directive 93/42/EEC of 14 Ju ne 1993 con cerni ng medical devices in cludi ng ame ndm

4、e nts through 05 Sep tember 20073.1.2.Guida nee Docume ntsEuropean Commissi on En ter prise-Directorate-Ge neral MEDDEV 2.12-2 Guideli nes on Post Market Cli nical Follow-U p 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

5、 bodies dated April 2009? GHTF Post-Market Cli ni cal Follow-U p Studies; SG5(PD)N4R7 (Pro posed docume nt 23 July 2008)? GHTF Cli nical In vestigati ons; SG5(PD)N3R7 (20 Jan uary 2008)4.ROLES AND RES PO NSIBILITIESImp orta nt: Whe n a title of a po siti on is listed in this work in struct ion, it r

6、elates to that p ositi on or its equivale nt.Below are the roles and respon sibilities discussed withi n this docume nt.Table 4-1: Roles and Respon sibilitiesRoleRespon sibilityDesig n Engin eeri ng an d/or Engin eeri ng Rep rese ntativeP rovide con sultati on to the P roduct Regulatory Affairs Repr

7、 ese ntative in determ ining for a give n project/p roduct whether a po st-market cli nical follow-u p study is requiredP rovide con sultati on to the P roduct Regulatory Affairs Repr ese ntative to determ ine if an equivale nt device existsP rovide con sultati on to the P roduct Regulatory Affairs

8、Repr ese ntative in iden tify ing emerg ing risks for the medical deviceProvide consultation to the Research Manager or desig nee to determine the type of po st-market cli nical follow-u p study to be imp leme nted, if app licableP roduct RegulatoryAffairs Rep rese ntativeDetermi ne for a give proje

9、ct/p roduct whether a po st-market cli nical follow-u p study is requiredDeterm ine if an equivale nt device existsIden tify p ote ntial emerg ing risksReview risk assessme nt?Comp lete the Po st-Market Cli nical Follow- Up Justificati on Form regard ingdecisi on to p erform a studyComp lete the Pos

10、t-Market Cli nical Follow- Up Plan form that details the po st-market cli ni cal follow-u p planDetermi ne how ofte n cli nical data must be reviewedReview and app rove the cli ni cal evaluati on p erformed by the ResearchManager or desig neeRegulatory AffairsRep rese ntative?Pr ovide con sultati on

11、 to the Research Man ager to determ ine the type ofpo st-market cli ni cal follow-u p study to be imp leme nted, if app licableTable 4-1: Roles and Respon sibilitiesRoleRespon sibilityResearch Man ager or desig neeP rovide con sultati on to the P roduct Regulatory Affairs Repr ese ntative in determ

12、ining for a give n project/p roduct whether a po st-market cli ni cal follow-u p study is requiredPr ovide con sultati on to the P roduct Regulatory Affairs Repr ese ntative to determ ine if an equivale nt device existsP rovide con sultati on to the P roduct Regulatory Affairs Repr ese ntative to id

13、en tify poten tial emerg ing risksReview the P ost-Market Cli ni cal Follow-Up Justificati on form and P ost-Market Cli nical Follow- Up Plan form to confirm the decisi ons regard ing the n eed for a po st-market cli ni cal follow-u p study and cli nical follow-u pDetermi ne how ofte n cli nical dat

14、a must be reviewed? Determ ine the type of po st-market cli ni cal follow-u p study to be imp leme nted, if app licableReview new data (i.e. literature, adverse eve nts, complain ts, etc,) and determ ine if a po st-market cli ni cal follow-u p study is n ecessary based on new in formatio n (cli nica

15、l evaluati on)Medical AffairsRep rese ntativeReview the P ost-Market Cli ni cal Follow-Up Justificati on form and P ost-Market Cli nical Follow- Up Plan form to confirm the decisi ons regard ing the n eed for a po st-market cli ni cal follow-u p study and cli nical follow-u p? Review and app rove th

16、e cli nical evaluati on p erformed by the Research Manager or desig nee5.WORK INSTRUCTIONPost-market cli ni cal mon itori ng is an esse ntial eleme nt in establishi ng long term safety follow- up data and po ssible emerge nt risks for medical devices. These risks and data cannot adequately be detect

17、ed and characterized by relying solely on p re-market cli ni cal in vestigati ons.Post market cli nical mon itori ng may in clude a comb in ati on of several strategies:? Product complaint review ? Post-market eve nt reporting review of users and p atie nts ? Literature review ? Post-market clinical

18、 follow-up studies (PMCFS)This work in structi on was created to determ ine whe n a PMCFS is n ecessary to maintain an adequate po st-market surveilla nee system, as required by the Medical Device Directive 93/42/ECC (MDD) as amen ded by MDD 2007/47/EC. It will alsop rovide guida nee on the po st-ma

19、rket cli nical mon itori ng requireme nts if a PMCFS is not required.P MCFSDeter min ati onFigure 5-1: High-Level Process Overview for Post-Market Cli nical Follow-U p5.1.Gen eral Requireme nts5.1.1.Prior to M3 sig n-off, the Product Regulatory Affairs Rep rese ntative in con sultati on with the Res

20、earch Man ager or desig nee and the Desig n Engin eeri ng an d/or Engin eeri ng Rep rese ntative shall determ ine for a give n p roject/ 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 p roducts for which me

21、dium/l on g-term cli nical p erforma nee and safety is already known from p revious use of the device or where other approp riate po st-market surveilla nee activities would p rovide sufficie nt data to address the risks.5.2.Determining the Type of Post-Market Clinical Follow-UpRequiredPost-market c

22、linical 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 an

23、d 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

24、 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 useTechnicalUsed under similar conditions of use;? Have similar specifications and properties;? Be of similar d

25、esign;Use similar deployment methods? Have similar principles of operationBiological? 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 already known from previous use of the device, or from f

26、ully 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 the same requirement.5.2.3.The need for a PMCFS shall be determined based on the identification of residual risks th

27、at 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 AffairsRepresentative in consultation with the Research Manager or de

28、signee 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;hig

29、h 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

30、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;.2.5.A properly conducted risk analysis is essential in determining w

31、hat clinical evidence may be needed for a particular device.Any risks identified as an“ unacceptable ”risk mitigatiorisk at the conclusion of the development process shall require a PMCFS. A study should also be considered for risks identified as “ acceptable ” or required ” if the diceevmeets any o

32、f 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 risk assessment.The Product Regulatory Affairs Representative shall complete the Post Market Cli

33、nical 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...5.3.1.The Product Regulatory Affairs Representative shal

34、l complete the Post-Market Clinical Follow-Up Plan (Appendix B) that details the plan for post-market clinical follow-up.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

35、to confirm the decisions regarding post-market clinical monitoring.No Post Market Clinical Follow-Up Study RequiredIf 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. Justificati on regard ing the deci

36、si on not to p erform a PMCFS must be clearly docume nted and mai ntai ned in the desig n history/tech ni cal file (see 5.2.5).5.3.3. Post-Market Cli nical Mon itori ng Requireme nts (mi nimum). At a minimum, the following post-market clinical monitoring activities shall be compi eted accord

37、ing to TDI Foot/A nkle Array 8ch established p rocedures/work in struct ions.These eleme nts will be inputs into the Post-Market LiteratureEvaluati on and Market An alysis Rep ort.Review of p roduct complaints accordi ng to Complaint Han dli ng ProcedureReview of post market adverse eve nts accord i

38、ng to Post Market Event Reporting ProcedureLiterature review accordi ng to TDI Foot/A nkle Array 8ch Evaluati on of Cli nical Data to Support CE Marki ng Work In structio n .. Review of product complaints, post market adverse events and the literature review shall be compi eted at the in terv

39、als sp ecified in Table 5-1. The tim ing outl ined p rovides the mi nimum requireme nts.The Product Regulatory AffairsRepresentative and/or the Research Manager or desig nee can determine that cli ni cal data shall be reviewed more ofte n.Table 5-1: Timing for Review of Cli ni cal Data based on Medi

40、cal Device ClassDevice Classificati onTiming for review of cli ni cal data (minimum)Class IAnnu allyClass Ila, IlbAt a minimum annu ally, should con sider more ofte nClass IIISemi-a nnu ally (i.e. twice a year), should con sider more ofte n. At the interval outlined in Table 5-1, the Research

41、 Manager or desig nee shall compi ete a literature review and an alysis of po st-market exp erie nces (i.e. complaints and adverse eve nts) and re-evaluate if a PMCFS n eeds to be con ducted based on this data. The Post Market Literature Evaluati on and Market An alysis Con clusi on form (Appen dix

42、D) shall be compi eted and maintained as part of the device ' s design history/technical file.The Product Regulatory Affairs Rep rese ntative and Medical Affairs Rep rese ntative shall review and app rove this docume nt.NOTE: The literature review shall be executed accord ing to the Evaluati on

43、of Cli nical Data toSupp ort CE Marki ng Work In structi on, secti on 5.5.However, the followi ng forms/te mp latesshall be used in pl ace of those sp ecified in this work in structi on:a.In stead of using The Literature Evaluati on Plan temp late refere need, use the PostMarket Literature Evaluati

44、on and Market Exp erie nee Plan form (Appen dix C)5.4.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)Post Market Clinical Follow-Up Study Required5.4.1.If it was determ

45、ined 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

46、.5.4.2.The PMCFS shall be carried out in accordance with TDI Foot/Ankle Array 8ch' s Research Involving Human Subjects Procedure.4.4.The Research Manager or designee in consultation with the Regulatory Affairs Representative and the Design Engineering and/or Engineering Representative wil

47、l determine the type of PMCFS that will be implemented.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 equiv

48、alence is claimed? New information becoming available. 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

49、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 literatu

50、re 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 be used in place of those specified in this work instruction:a. Instead of using The Literature Evaluation Plan template referenced

51、, 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 cli

52、nical follow-up study5.5.1.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

53、 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 addr

54、ess 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

55、 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

56、from the PMCFS are used to provide clinical evidence to support the post-market surveillance program.This process may resultin the need to reassess whether the device continues to comply with the Essential Principles. Such assessments may result in corrective or preventive actions.6.APP ENDIX6.1.App

57、en dix A: P ost-Market Cli nical Follow-U p Study Determ in ati onXXXXXXX Healthcare<Name of Regulatory Affairs Represen tative> |<Locati on/Con tact In formationXXXXXXX Device:This form is used to docume nt the rati on ale for determ ining the n eed for a po st-market cli ni cal follow-up study.Once complete, this