上市后临床跟踪管理程序(共17页).doc

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1、精选优质文档-倾情为你奉上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： 17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

2、 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 TDI Foot/Ankle A

3、rray 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. Laws Council Directive 93/42/EEC of 14 June 1993 concerning medical devices including amendments through 05 September 2

4、0073.1.2. 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-Marke

5、t 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 rol

6、es and responsibilities discussed within this document.Table 41: Roles and ResponsibilitiesRoleResponsibilityDesign Engineering and/or Engineering Representative Provide consultation to the Product Regulatory Affairs Representative in determining for a given project/product whether a post-market cli

7、nical follow-up study is required Provide consultation to the Product Regulatory Affairs Representative to determine if an equivalent device exists Provide consultation to the Product Regulatory Affairs Representative in identifying emerging risks for the medical device Provide consultation to the R

8、esearch Manager or designee to determine the type of post-market clinical follow-up study to be implemented, if applicableProduct Regulatory Affairs Representative Determine for a give project/product whether a post-market clinical follow-up study is required Determine if an equivalent device exists

9、 Identify potential emerging risks Review risk assessment Complete the Post-Market Clinical Follow-Up Justification Form regarding decision to perform a study Complete the Post-Market Clinical Follow-Up Plan form that details the post-market clinical follow-up plan Determine how often clinical data

10、must be reviewed Review and approve the clinical evaluation performed by the Research Manager or designeeRegulatory Affairs Representative Provide consultation to the Research Manager to determine the type of post-market clinical follow-up study to be implemented, if applicableResearch Manager or de

11、signee Provide consultation to the Product Regulatory Affairs Representative in determining for a given project/product whether a post-market clinical follow-up study is required Provide consultation to the Product Regulatory Affairs Representative to determine if an equivalent device exists Provide

12、 consultation to the Product Regulatory Affairs Representative to identify potential emerging risks Review 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 cli

13、nical follow-up Determine how often clinical data must be reviewed Determine the type of post-market clinical follow-up study to be implemented, if applicable Review new data (i.e. literature, adverse events, complaints, etc,) and determine if a post-market clinical follow-up study is necessary base

14、d on new information (clinical evaluation)Medical Affairs Representative Review 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-up Review and

15、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 emergent risks for medical devices. These risks and data cannot adequately be detected

16、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 users and patients Literature review Post-market clinical follow-up studies (PMCFS

17、) 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/EC. It will also provide guidance on the post-market clinical monitoring requireme

18、nts if a PMCFS is not required.Figure 5-1: High-Level Process Overview for Post-Market Clinical Follow-Up5.1. 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 Enginee

19、ring Representative shall determine for a given project/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 products for which medium/long-term clinical performance and safety is already known from previous us

20、e 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-Up RequiredPost-market clinical monitoring shall have one of two outcomes, (1) PMCFS required or (2) no PMCFS req

21、uired. 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 and Design Engineering and/or Engineering Representative shall determine whether an equiv

22、alent 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 site in the body; Used in similar population (including age, anatomy, physiology); Have s

23、imilar 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 o

24、r 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 fully transferable experience with equivalent devices shall not require a PMCFS. NOTE: If th

25、e device quoted as the “equivalent” requires a PMCFS, then the new product 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 that may impact the risk/benefit ratio. A study should always be considered for devices wh

26、ere the identification of possible emerging risks and the evaluation of long term safety and performance 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 eme

27、rging 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

28、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 larger population; well known risks identified from

29、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 evidence may be needed for a particular device. Any risks identified as an “un

30、acceptable” risk at the conclusion of the development process shall require a PMCFS. 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 p

31、erformed according to the Risk Management Procedure. The Product Regulatory Affairs 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 regardin

32、g 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-Market Clinical Follow-Up Plan (Appendix B) that details the plan for pos

33、t-market clinical follow-up. 5.2.7. 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.5.3. No Post Marke

34、t Clinical Follow-Up Study Required5.3.1. If 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. Justification regarding the decision not to perform a PMCFS must be clearly documented and maintained in th

35、e 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 be completed according to TDI Foot/Ankle Array 8ch established procedures/work instructions. These elements

36、will be inputs into the Post-Market Literature Evaluation 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

37、 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 review shall be completed at the intervals specified in Table 5-1. The timing outlined provides the minimum requirements. The Product Regulatory A

38、ffairs Representative and/or the Research Manager or designee can determine 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 mi

39、nimum annually, should consider more oftenClass IIISemi-annually (i.e. twice a year), should consider more often5.3.3.3. 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

40、nts) and re-evaluate if a PMCFS needs to be conducted based on this data. 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 M

41、edical 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/templates shall be used in place of those specified in thi

42、s work instruction:a. Instead of using 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

43、 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 listed under 5.3.3, studies such as extended follow-up of patients enrolled in the pre-market trials, prospe

44、ctive study of a representative subset of patients after 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

45、 consultation with the Regulatory Affairs Representative 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 iden

46、tified 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 shall complete a literature review and anal

47、ysis 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 devices design history/technical file. The Product Regulato

48、ry 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/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 Post Market Literature Evaluation and Market Experience Plan form (Appendix C)b. Instead o