上市后临床跟踪管理程序

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

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▪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 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 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

Table 4-1: Roles and Responsibilities

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: ▪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 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.