上市后临床跟踪管理程序文件

1、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：贝码：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 lead to a deter

2、mination ofwhether 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 Array 8ch Healthca

3、re 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 20073.1.2. Guidanc

4、e 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-Market Clinical Fol

5、low-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 roles and responsi

6、bilities discussed within this document.Table 4-1: 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 clinical follow-

7、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 Research Ma

8、nager or designee to determine the type of post-market clinical follow-up study to be implemented, if applicableProduct RegulatoryAffairs Representative? Determine for a give project/product whether a post-market clinical follow-up study is required?Determine if an equivalent deviceexists?Identify p

9、otential emerging risks?Review risk assessment?Complete the Post-Market Clinical Follow-Up Justification Form regardingdecision 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 must be re

10、viewed? 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 applicableTable 4-1: Roles and Responsib

11、ilitiesRoleResponsibilityResearch Manager or designee? 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

12、 determine if an equivalent device exists? Provide 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

13、 for a post-market clinical follow-up study and clinical 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

14、post-market clinical follow-up study is necessary based on new information (clinical evaluation)Medical AffairsRepresentative? 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 clini

15、cal follow-up study and clinical follow-up? Review 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 emergent risks for medical devic

16、es. 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 users and patients? Liter

17、ature 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/EC. It will alsoprovide

18、guidance on the post-market clinical monitoring requirements if a PMCFS is not required.PMCFSDeterminationFigure 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

19、 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 also determine the post-market clinical follow-up plan.5.1.2. A PMCFS may not be required for products for which medium/l

20、ong-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 data to address the risks.5.2. Determining the Type of Post-Market Clinical Follow-UpRequiredPost-market clinical monitori

21、ng 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 and Design Engine

22、ering 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 site in the bo

23、dy;? Used in similar population (including age, anatomy, physiology);? Have similar 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 s

24、imilar deployment methods? Have similar principles of operation? Biological? 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 fully tra

25、nsferable 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 that may

26、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 designee

27、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;? high r

28、isk 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 i

29、n 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;5.2.4. A properly conducted risk analysis is essential in determining what

30、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 risks identified as“ acceptable ” or “ risk mitigatirequired ” if the diceevmeets any of t

31、he 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 assessment.5.2.5. The Product Regulatory Affairs Representative shall complete the Post Marke

32、t 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 about the need to perform a PMCFS.5.2.6. The Product Regulatory Affairs Representative shall complet

33、e 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 the Post-Market Clinical Follow-Up Justification Form and The Post-Market Clinical Follow-Up Plan to

34、 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-market clinical monitoring is still required for the medical device.5.3.2. Justification regarding

35、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 minimum, the following post-market clinical monitoring activities shall be completed according to

36、TDI Foot/Ankle Array 8ch established procedures/work instructions. These elements 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 Mark

37、et Event Reporting Procedure? Literature review according to TDI Foot/Ankle Array 8ch 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

38、 5-1. The timing outlined provides the minimum requirements. The Product Regulatory Affairs 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 Classific

39、ationTiming for review of clinical data (minimum)Class IAnnuallyClass IIa, IIbAt a minimum 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 liter

40、ature 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. The Post Market Literature Evaluation and Market Analysis Conclusion form (Appendix D) shall be completed and maintained as part of the devic

41、e ' 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

42、.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 of using The Literatu

43、re Evaluation Report and Conclusion template, use the Post-Market Literature Evaluation and 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.

44、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.5.4.2. The PMCFS shall be carried out in accordance with TDI Foot/Ankle Array 8

45、ch sResearch Involving Human Subjects Procedure5.4.3. The Research Manager or designee in 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 a

46、ccount 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 equivalence is claimed? New information becoming available5.4.4.1. At the interval outli

47、ned 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 Post Market Literature Evaluation and Market Analysis Conclusion form (Appendix D)

48、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 toSupport CE Ma

49、rking 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

50、)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)5.5.1.5.5.2.5.5.3.5.5.4.5.5.5.5.5.6.5.5. Elements of a post-market clinical follow-up studyPost-market clinical follow-u

51、p studies are performed on a device within its intended use/purpose(s) according to the instructions for use.A PMCFS shall include the elements defined in the Writing Clinical Investigational Plans and Protocols Work Instruction.The objective(s) of a PMCFS should be stated clearly and should address

52、 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.Post-market clinical follow-up studies should be designed to address the objective(s) of the study. The design may vary based on the object

53、ive(s) and should be scientifically sound to allow for valid conclusions to be drawn.The study design can take several forms, for example:? the extended follow-up of patients enrolled in pre-market investigations;? a new clinical investigation;? a review of data derived from a device registry;? a re

54、view of relevant retrospective data from patients previously exposed to the device.? the analysis plan including any interim reporting; and? procedures for early study termination.The data and conclusions derived from the PMCFS are used to provide clinical evidence to support the post-market surveil

55、lance program. This process may result in the need to reassess whether the device continues to comply with the Essential Principles. Such assessments may result in corrective or preventive actions.6. APPENDIX6.1. Appendix A: Post-Market Clinical Follow-Up Study DeterminationXXXXXXX Healthcare<Nam

56、e of Regulatory Affairs Representative<Location/Contact InformationXXXXXXX Device:This form is used to document the rationale for determining the need for a post-market clinical follow-up study. Once complete, this form shall be saved as part of the devic e' s technical file.Section 1: Determ

57、ine 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/device name:Proposed equivalent device model number:Questions 1-10 must be answered yes or n/a

58、 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?Explain:Yes 匚|No 2. Is the proposed equivalent device used at the same site in the body as the device?Explain:Yes 匚INo 匚|3. Is the proposed equivalent device used in a similar population (including age, anatomy,