上市后临床跟踪管理系统程序.docx

1、上市后临床跟踪管理系统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： 3编制：审核：批准：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. The process will l

2、ead 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 TDI Foot/Ankle Arra

3、y 8ch Healthcare Quality Management System. Only medical devices bearing the CE Mark will be required to follow this work instruction.3.ReferencesExternal ReferencesLawsCouncil Directive 93/42/EEC of 14 June 1993 concerning medical devices including amendments through 05 September 2007Guidance Docum

4、entsEuropean 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 Post-Market Clinical Follow-Up Studie

5、s; 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 discu

6、ssed within this document.Table 41: Roles and ResponsibilitiesRoleResponsibilityDesign Engineering and/or Engineering RepresentativeProvide consultation to the Product Regulatory Affairs Representative in determining for a given project/product whether a post-market clinical follow-up study is requi

7、redProvide 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 deviceProvide consultation to the Research Manager or designee to de

8、termine 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 equivalent device existsIdentify potential emerging risksRe

9、view 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 often clinical data must be reviewedReview and approve the c

10、linical 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 applicableResearch Manager or designeeProvide consultation to the Product

11、Regulatory Affairs Representative in determining for a given project/product 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 Affai

12、rs Representative to identify potential emerging risksReview 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-upDetermine how often clinical da

13、ta must be reviewedDetermine the type of post-market clinical follow-up study to be implemented, if applicableReview 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

14、 Affairs RepresentativeReview 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-upReview and approve the clinical evaluation performed by the Re

15、search Manager or designee5.Work InstructionPost-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 cl

16、inical investigations.Post market clinical monitoring may include a combination of several strategies:Product complaint reviewPost-market event reporting review of users and patientsLiterature review Post-market clinical follow-up studies (PMCFS) This work instruction was created to determine when a

17、 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 P

18、rocess Overview for Post-Market Clinical Follow-UpGeneral RequirementsPrior 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 whe

19、ther a PMCFS is required. They shall also determine the post-market clinical follow-up plan. 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 activi

20、ties would provide sufficient data to address the risks.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. The need for a PMCFS shall be based on a combination of several factors

21、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 essential characteri

22、stics 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 in

23、tended 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 fluidsProducts for which the med

24、ium/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

25、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 performance are es

26、sential. 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 devi

27、ce, 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.);ide

28、ntification 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

29、 life of the product;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 r

30、isks 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 ass

31、essment. 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. 1NOTE:This form may also be used as a guide in making the determination about the need

32、to perform a PMCFS.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. 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.