1、精選優(yōu)質(zhì)文檔-傾情為你奉上專心-專注-專業(yè)上市后臨床跟蹤控制程序上市后臨床跟蹤控制程序文件編號： QP-29版本：A/0生效日期： 頁碼： 17編制：審核：批準：1.PURPOSEThe 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

2、. 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.SCOPEThe work instruction applies to all medical device businesses and sites operating under the

3、 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.REFERENCES3.1.External References3.1.1.LawsCouncil Directive 93/42/EEC of 14 June 1993 concerning medical devices including amendments through 0

4、5 September 20073.1.2.Guidance DocumentsEuropean Commission Enterprise-Directorate-General MEDDEV 2.12-2 Guidelines on Post Market Clinical Follow-Up dated May 2004MEDDEV 2.7.1 Rev.3 guidelines on medical device-clinical evaluation-a guide for manufacturers and notified bodies dated April 2009GHTF P

5、ost-Market Clinical Follow-Up Studies; SG5(PD)N4R7 (Proposed document 23 July 2008)GHTF Clinical Investigations; SG5(PD)N3R7 (20 January 2008)精選優(yōu)質(zhì)文檔-傾情為你奉上專心-專注-專業(yè)4.ROLES AND RESPONSIBILITIESImportant: When a title of a position is listed in this work instruction, it relates to that position or its

6、equivalent.Below are the roles and responsibilities discussed within this document.Table 4-1: Roles and ResponsibilitiesRoleResponsibilityDesign Engineering and/or Engineering RepresentativeProvide consultation to the Product Regulatory Affairs Representative in determining for a given project/produ

7、ct whether a post-market clinical follow-up study is requiredProvide consultation to the Product Regulatory Affairs Representative to determine if an equivalent device existsProvide consultation to the Product Regulatory Affairs Representative in identifying emerging risks for the medical deviceProv

8、ide consultation to the Research Manager or designee to determine the type of post-market clinical follow-up study to be implemented, if applicableProduct Regulatory Affairs RepresentativeDetermine for a give project/product whether a post-market clinical follow-up study is requiredDetermine if an e

9、quivalent device existsIdentify potential emerging risksReview risk assessmentComplete the Post-Market Clinical Follow-Up Justification Form regarding decision to perform a studyComplete the Post-Market Clinical Follow-Up Plan form that details the post-market clinical follow-up planDetermine how of

10、ten clinical data must be reviewedReview and approve the clinical evaluation performed by the Research Manager or designeeRegulatory Affairs RepresentativeProvide consultation to the Research Manager to determine the type of post-market clinical follow-up study to be implemented, if applicable精選優(yōu)質(zhì)文檔

11、-傾情為你奉上專心-專注-專業(yè)Table 4-1: Roles and ResponsibilitiesRoleResponsibilityResearch Manager or designeeProvide consultation to the Product Regulatory Affairs Representative in determining for a given project/product whether a post-market clinical follow-up study is requiredProvide consultation to the Pro

12、duct Regulatory Affairs Representative to determine if an equivalent device existsProvide consultation to the Product Regulatory Affairs Representative to identify potential emerging risksReview the Post-Market Clinical Follow-Up Justification form and Post-Market Clinical Follow-Up Plan form to con

13、firm the decisions regarding the need for a post-market clinical follow-up study and clinical follow-upDetermine how often clinical data must be reviewedDetermine the type of post-market clinical follow-up study to be implemented, if applicableReview new data (i.e. literature, adverse events, compla

14、ints, etc,) and determine if a post-market clinical follow-up study is necessary based on new information (clinical evaluation)Medical Affairs RepresentativeReview the Post-Market Clinical Follow-Up Justification form and Post-Market Clinical Follow-Up Plan form to confirm the decisions regarding th

15、e need for a post-market clinical follow-up study and clinical follow-upReview and approve the clinical evaluation performed by the Research Manager or designee5.WORK INSTRUCTIONPost-market clinical monitoring is an essential element in establishing long term safety follow-up data and possible emerg

16、ent 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

17、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/

18、EC. It will also provide guidance on the post-market clinical monitoring requirements if a PMCFS is not required.精選優(yōu)質(zhì)文檔-傾情為你奉上專心-專注-專業(yè)Figure 5-1: High-Level Process Overview for Post-Market Clinical Follow-UpDetermine whether an equivalent device existsIdentify residual risks/emerging risksReview Ri

19、sk Assessment documentEvaluate need for PMCFSPMCFS Required?PMCFS DeterminationPerform PMCFS in accordance with GEHC_GQP_10.03 and GEHC_GQP_10.03.002YESAt a minimum, review clinical data including, AEs, complaints and literatureNOReview new data and determine the need to a PMCFS based on new informa

20、tion5.1.General Requirements5.1.1.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

21、 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

22、data to address the risks.5.2.Determining the Type of Post-Market Clinical Follow-Up RequiredPost-market clinical monitoring shall have one of two outcomes, (1) PMCFS required or (2) no PMCFS required. 精選優(yōu)質(zhì)文檔-傾情為你奉上專心-專注-專業(yè)The need for a PMCFS shall be based on a combination of several factors detai

23、led 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 character

24、istics 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 specific i

25、ntended useTechnical Used 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 fluids5.2.2.Products for which

26、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 th

27、e 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 perfo

28、rmance 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 desig

29、n 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.);精選優(yōu)質(zhì)文檔-傾情為你奉上專心-專注-專業(yè)severity of disease/treatment challenges;sensitivity of target population (i.e., infants, c

30、hildren, 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 foll

31、ow-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.

32、 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

33、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 guid

34、e 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

35、 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 Required5.3.1.If it was determined that no PMCFS is required (

36、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 Requirem

37、ents (minimum). At a minimum, the following post-market clinical monitoring activities shall be completed according to TDI Foot/Ankle Array 8ch established procedures/work 精選優(yōu)質(zhì)文檔-傾情為你奉上專心-專注-專業(yè)instructions. These elements will be inputs into the Post-Market Literature Evaluation and Market An

38、alysis Report. Review of product complaints according to Complaint Handling Procedure Review of post market adverse events according to Post Market Event Reporting ProcedureLiterature review according to TDI Foot/Ankle Array 8ch Evaluation of Clinical Data to Support CE Marking Work Instruction .5.3

39、.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 determ

40、ine that clinical data shall be reviewed more often.Table 5-1: Timing for Review of Clinical Data based on Medical Device ClassDevice ClassificationTiming for review of clinical data (minimum)Class IAnnuallyClass IIa, IIbAt a minimum annually, should consider more oftenClass IIISemi-annually (i.e. t

41、wice a year), should consider more often. 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

42、. The Post Market Literature Evaluation and Market Analysis Conclusion form (Appendix D) shall be completed and maintained as part of the devices design history/technical file. The Product Regulatory Affairs Representative and Medical Affairs Representative shall review and approve this document.NOT

43、E: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 temp

44、late 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)精選優(yōu)質(zhì)文檔-傾情為你奉上專心-專注-

45、專業(yè)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 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

46、 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 8chs Research Involving Human Subjects Procedure 5.4.3.The Research Manager or designee in consultation with the Regulatory Affairs Representative a

47、nd 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 made b

48、y the manufacturer for the devicePerformances for which equivalence is claimedNew 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 eve

49、nts) 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 devices design history/technical file. The Product Regulatory Affairs Representative and Medical Affairs Representative sha

50、ll 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 us

51、ing 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 Conclusi

52、on 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 intended use/purpose(s) according to the instructions for use.5.5.2.A PMCFS shall include the elements defined in the Writing Clinical Investiga

53、tional Plans and Protocols Work Instruction.精選優(yōu)質(zhì)文檔-傾情為你奉上專心-專注-專業(yè)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 devi

54、ce.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 ext

55、ended 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

56、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 assessme

57、nts may result in corrective or preventive actions.精選優(yōu)質(zhì)文檔-傾情為你奉上專心-專注-專業(yè)6.APPENDIX6.1.Appendix A: Post-Market Clinical Follow-Up Study DeterminationXXXXXXX HealthcareXXXXXXX Device: This form is used to document the rationale for determining the need for a post-market clinical follow-up study. Once

58、complete, this form shall be saved as part of the devices 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/devi

59、ce 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? Explai

60、n: 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