上市后临床跟踪管理程序
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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
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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.