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合用文档上市后临床追踪控制程序文件编号： QP-29版本： A/0见效日期：页码： 19编制：审察：赞同：1.PURPOSEThe purpose of thiswork instructionisto definethe process todetermineand document whether a post-market clinical follow-up study is requiredforTDI Foot/Ankle Array 8ch medical devices bearing the CE mark. Theprocess will lead

2、 to a determination of whether a post-market clinicalfollow-up study isrequired and provideguidancefor post-marketclinicalmonitoring 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 Hea

3、lthcare 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 05 September 20073.1.2. Guida

4、nce DocumentsEuropean Commission Enterprise-Directorate-General MEDDEV 2.12-2 Guidelines on Post Market Clinical Follow-Up dated May 2004MEDDEV2.7.1 Rev.3 guidelines on medical device-clinical evaluation-aguide for manufacturers and notified bodies dated April 2009GHTF Post-Market Clinical Follow-Up

5、 Studies; SG5(PD)N4R7 (Proposed document 23 July 2008)GHTF Clinical Investigations; SG5(PD)N3R7 (20 January 2008)文案大全Product Regulatory Affairs RepresentativeRegulatory Affairs RepresentativeDesign Engineering and/or Engineering RepresentativeRole合用文档4.ROLES AND RESPONSIBILITIESImportant: When a tit

6、le of a position is listed in this work instruction, it relates to that position or its equivalent.Below are the roles and responsibilities discussed within this document.Table 4-1: Roles and ResponsibilitiesResponsibilityProvide consultation to the Product Regulatory Affairs Representative in deter

7、mining for a given project/product whether a post-market clinical follow-up study is requiredProvide consultation to the Product Regulatory AffairsRepresentative to determine if an equivalent device existsProvide consultation to the Product Regulatory AffairsRepresentative in identifying emerging ri

8、sks for the medicaldeviceProvide consultation to the Research Manager or designee todetermine the type of post-market clinical follow-up study tobe implemented, if applicableDetermine for a give project/product whether a post-market clinical follow-up study is requiredDetermine if an equivalent devi

9、ce 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 thatdetails the post-market clinical follow-up planDetermine how often clinical da

10、ta must be reviewedReview and approve the clinical evaluation performed by theResearch Manager or designeeProvide consultation to the Research Manager to determine thetype of post-market clinical follow-up study to be implemented, if applicable文案大全合用文档Table 4-1: Roles and ResponsibilitiesRoleRespons

11、ibilityResearch Manager orProvide consultation to the Product Regulatory AffairsdesigneeRepresentative in determining for a given project/productwhether a post-market clinical follow-up study is requiredProvide consultation to the Product Regulatory AffairsRepresentative to determine if an equivalen

12、t device existsProvide consultation to the Product Regulatory AffairsRepresentative to identify potential emerging risksReview the Post-MarketClinicalFollow-UpJustificationformandPost-Market Clinical Follow-Up Plan form to confirm thedecisions regarding the need for a post-market clinicalfollow-up s

13、tudy and clinical follow-upDetermine how often clinical data must be reviewedDetermine the type of post-market clinical follow-up study tobe implemented, if applicableReview new data (i.e. literature, adverse events, complaints,etc,) and determine if a post-market clinical follow-up studyis necessar

14、y based on new information (clinical evaluation)Medical AffairsReview the Post-MarketClinicalFollow-UpJustificationformandRepresentativePost-Market Clinical Follow-Up Plan form to confirm thedecisions regarding the need for a post-market clinicalfollow-up study and clinical follow-upReview and appro

15、ve the clinical evaluation performed by theResearch 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 medicaldevices. These risks and data cannot adequately be detected and char

16、acterized by relying solely on pre-market clinical investigations.Post market clinical monitoring may include a combination of several strategies:Product complaint reviewPost-market event reporting review of users and patientsLiterature reviewPost-market clinical follow-up studies (PMCFS)This work i

17、nstruction was created to determine when a PMCFSis necessary to maintain an adequate post-market surveillance system, as required by文案大全合用文档the Medical Device Directive 93/42/ECC (MDD) as amended by MDD2007/47/EC.It will also provide guidance on the post-market clinical monitoringrequirements if a P

18、MCFS is not required.Figure 5-1: High-Level Process Overview for Post-Market Clinical Follow-UpDetermine whether an equivalentdevice existsIdentify residual risks/emergingrisksPMCFSDeterminationReview Risk AssessmentdocumentEvaluate need for PMCFSPMCFSRequired?YESNOPerform PMCFS in accordancewith GE

19、HC_GQP_10.03 andAt a minimum, review clinical dataincluding, AE 抯, complaints andliteratureReview new data and determinethe need to a PMCFS based onnew information5.1. General Requirements5.1.1. Prior to M3 sign-off, the Product Regulatory Affairs Representative in consultation with the Research Man

20、ager 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/long-term clinical

21、 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.文案大全合用文档5.2. Determining the Type of Post-Market Clinical Follow-UpRequiredPost-market clinical monitoring shall

22、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 Engineering and

23、/or Engineering Representative shall determine whether an equivalent device exists. Equivalence shall be demonstrated in all the essential characteristics precisely defined below. Equivalence means:ClinicalUsed for the same clinical condition or purpose;Used at the same site in the body;Used in simi

24、lar population (including age, anatomy,physiology);Have similar relevant critical performance according toexpected clinical effect for specific intended useTechnicalUsed under similar conditions of use;Have similar specifications and properties;Be of similar design;Use similar deployment methodsHave

25、 similar principles of operationBiologicalSame 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 safetyis already known from previous use of the device, or from fully transferable experience with equivalent

26、 devices shall not require aPMCFS.NOTE:If the device quoted as the “ equivalent ” requires a PMCFS, thenthe 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 stu

27、dy should文案大全合用文档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 Affairs Representative inconsultation with the Research Manager or designee and Design Engineering and/or

28、 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 risk anatomical locations (i.e., h

29、eart, central nervoussystem, 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 in a longer term and/or through a larger p

30、opulation;well known risks identified from the literature or similarmarketed 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 risksidentified as an “ unacceptable ” risk at the conclusion of the development process shall require a PMCFS. A study should also beconsidered for risks identified as “acceptable ” or “ risk mitigation required ” if the device meets any of the other characteristicside