上市后临床跟踪管理程序.docx

1、上市后临床跟踪管理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 le

2、ad 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 ReferencesLaws Council Directive 93/42/EEC of 14 June 1993 concerning medical devices including amendments through 05 September 2007Guidance Doc

4、uments European Commission Enterprise-Directorate-General MEDDEV Guidelines on Post Market Clinical Follow-Up dated May 2004 MEDDEV guidelines on medical device-clinical evaluation-a guide for manufacturers and notified bodies dated April 2009 GHTF Post-Market Clinical Follow-Up Studies; SG5(PD)N4R7

5、 (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 discussed within

6、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 clinical follow-up study is required Provide

7、 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 Manager or designee to determine

8、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 Identify potential emerging risks Review

9、 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 must be reviewed Review and approve the c

10、linical 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 designee Provide consultation to the Produc

11、t 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 consultation to the Product Regulatory A

12、ffairs 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 clinical follow-up Determine how often clini

13、cal data must be reviewed Determine the type of post-market clinical follow-up study to be implemented, if applicable Review new data . literature, adverse events, complaints, etc,) and determine if a post-market clinical follow-up study is necessary based on new information (clinical evaluation)Med

14、ical 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 approve the clinical evaluation performed by

15、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 and characterized by relying solely on pre-ma

16、rket 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) This work instruction was created to determ

17、ine 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 requirements if a PMCFS is not required.Figure 5-1: Hi

18、gh-Level Process 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/p

19、rogram whether 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 surveilla

20、nce activities 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 severa

21、l factors 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

22、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 similar relevant critical performance according to expected clinical effect f

23、or 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 or similar use of materials in contact with human tissues or body fluidsProdu

24、cts 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 the device quoted as the “equivalent” requires a PMCFS, then the new product shall be

25、 subject to the same 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 a

26、nd 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 emerging risk, the following criteria should be taken into account: innovation, ., where the

27、design of the device, the materials, the principles of operation, the technology or the medical indications are novel; high risk anatomical locations ., heart, central nervous system, etc.); severity of disease/treatment challenges; sensitivity of target population ., infants, children, pregnant wom

28、en, 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 follow-up time scales

29、and the expected 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

30、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 The risk assessment shall be performed according to the Risk Management Procedure. The Product Regulatory Affairs Representative shall review the

31、 risk assessment. 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

32、 the need 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 m