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： 19

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1.PURPOSE

The 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 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.SCOPE

The work instruction applies to all medical device businesses and sites operating under the TDI Foot/Ankle Array 8ch Healthcare Quality

Management System.

Only medical devices bearing the CE Mark will be required to follow this work instruction.

3.REFERENCES

3.1.External References

https://www.360docs.net/doc/123938909.html,ws

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

including amendments through 05 September 2007

3.1.2.Guidance Documents

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 (Proposed

document 23 July 2008)

GHTF Clinical Investigations; SG5(PD)N3R7 (20 January 2008)

4.ROLES AND RESPONSIBILITIES

Important: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 this document. Table 4-1: Roles and Responsibilities

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 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 the type of post-market clinical follow-up study to

be implemented, if applicable

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 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 clinical evaluation performed by the

Research Manager or designee

Provide consultation to the Research Manager to determine the

type of post-market clinical follow-up study to be implemented,

if applicable

Table 4-1: Roles and Responsibilities Role Responsibility

Research 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 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 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 . literature, adverse events, complaints, etc,) and determine if a post-market clinical follow-up study is necessary based 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 approve the clinical evaluation performed by the Research Manager or designee

5.WORK INSTRUCTION

Post-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 clinical investigations.

Post market clinical monitoring may include a combination of several strategies:

P roduct complaint review

P ost-market event reporting review of users and patients

L iterature review

P ost-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 also provide guidance on the post-market clinical monitoring

requirements if a PMCFS is not required.

Figure 5-1: High-Level Process Overview for Post-Market Clinical Follow-Up

PMCFS

Determination

5.1.General Requirements

5.1.1.Prior to M3 sign-off, the Product Regulatory Affairs Representative in

consultation with the Research Manager or designee and the Design

Engineering and/or 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 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-Up

Required

Post-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 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 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 body;

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 similar deployment methods

Have similar principles of operation

Biological

Same or similar use of materials in contact with human tissues

or body fluids

5.2.2.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 the 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 where 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 emerging risk, the following criteria should be taken into account:

innovation, ., where the 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

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 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 “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 mitigation required” if the device meets any of the other char acteristics

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 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 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 complete 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 confirm the decisions regarding post-market clinical monitoring.

5.3.No Post Market Clinical Follow-Up Study Required

5.3.1.If it was determined that no PMCFS is required (based on section ,

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 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 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 Market 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 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 Class

Device Classification Timing for review of clinical data (minimum)

Class I Annually

Class IIa, IIb At a minimum annually, should consider more

often

Class III Semi-annually . twice a year), should consider

more often

5.3.3.3.At the interval outlined in Table 5-1, the Research Manager or

designee shall complete a literature review and analysis of post-market experiences . 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 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 to Support CE Marking Work Instruction, section . 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 Literature 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 Required

5.4.1.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, 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

8ch’s Research Involving Human Subjects Procedure

5.4.3.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 account 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 available

5.4.4.1.At the interval outlined in Table 5-1, the Research Manager or

designee shall complete a literature review and analysis of post-market experiences . 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 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 to Support CE Marking Work Instruction, section . 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 Literature Evaluation Report and Conclusion template,

use the Post-Market Literature Evaluation and Market Analysis Report and

Conclusion form (Appendix D)

5.5.Elements of a post-market clinical follow-up study

5.5.1.Post-market clinical follow-up studies are performed on a device within

its intended use/purpose(s) according to the instructions for use.

5.5.2.A PMCFS shall include the elements defined in the Writing Clinical

Investigational Plans and Protocols Work Instruction.

5.5.3.The objective(s) of a PMCFS should be stated clearly and should address

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.

5.5.4.Post-market clinical follow-up studies should be designed to address the

objective(s) of the study. The design may vary based on the objective(s) and should be scientifically sound to allow for valid conclusions to be drawn.

5.5.5.The study design can take several forms, for example:

t he extended follow-up of patients enrolled in pre-market

investigations;

a new clinical investigation;

a review of data derived from a device registry;

a review of relevant retrospective data from patients previously

exposed to the device.

t he analysis plan including any interim reporting; and

p rocedures for early study termination.

5.5.

6.The data and conclusions derived from the PMCFS are used to provide

clinical evidence to support the post-market surveillance 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.APPENDIX

6.1.Appendix A: Post-Market Clinical Follow-Up Study

Determination

6.2.Appendix B: Post-Market Clinical Follow-Up Plan

6.3.Appendix C: Post Market Literature Evaluation and Market

Experience Analysis Plan

6.4.Appendix D: Post-Market Literature Evaluation and Market

Analysis Report and Conclusion