上市后临床跟踪管理程序.docx
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上市后临床跟踪管理程序.docx
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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
编制:
生效日期:
审核:
页码:
17
批准:
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
3.1.1.Laws
▪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
Role
Design Engineering
and/or Engineering
Representative
Responsibility
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
Product 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 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
Regulatory Affairs
Representative
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
Research Manager or
designee
Responsibility
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 (i.e. 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:
▪ 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
Determine whether an equivalent
device exists
Identify residual risks/emerging
risks
PMCFS
Determination
Review Risk Assessment
document
Evaluate need for PMCFS
PMCFS
Required?
YES
NO
Perform PMCFS in accordance
with GEHC_GQP_10.03 and
GEHC_GQP_10.03.002
At a minimum, review clinical data
including, AE抯 complaints and
literature
Review new data and determine
the need to a PMCFS based on
new information
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, 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., heart, central nervous system, 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
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 characteristics identified in 5.2.1 and
5.2.2.The risk assessment shall be performed according to the Risk Management
Procedure. The Product
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