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1. PURPOSE
The purpose of this procedure is to provide for systematic data collection, analysis, reporting and review of
information about the safety and efficacy of products that have been released to the market.
2. SCOPE
This procedure covers all products that have been transferred from product development to post-market surveillance.
This is the primary document meeting the applicable regulatory requirements for Post-Market Surveillance, and a
supporting document for Risk Management (SYS-010), as defined in [Company Name]’s Quality System Manual
(POL-001).
3. REFERENCES AND RELATIONSHIPS




EN ISO 14971: 2012 Medical Devices – Application of risk management to medical devices, §9
ISO TIR 24971:2013 Medical Devices – Guidance on the application of ISO 14971, §4
MEDDEV. 2.7/1 Rev.3 2009 Guidelines on medical devices. Clinical Evaluation: A guide for
manufacturers and Notified Bodies
MEDDEV 2.12/2 Rev 2 January 2012 Guidelines on medical devices. Post-Market Clinical Follow-up
Studies
SYS-008 Product
Development Procedure
SYS-009 Clinical Procedure
SYS-010 Risk Management
Procedure
SYS-018 Customer Feedback
& Complaint Handling
Procedure
SYS-020 Field Action
Procedure
PMS File
SYS-019 Post-Market
Surveillance Procedure
SYS-024 CAPA Procedure
SYS-003 Management
Review Procedure
SYS-023 Nonconforming
Product Procedure
SYS-013 Servicing
Procedure
SYS-024 CAPA Procedure
4. DOCUMENT APPROVAL
Changes to this procedure document and associated forms and templates are to be approved by:
 PMS Process Owner
 Quality Manager.
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5. REVISION HISTORY
Ver
Date
mm/dd/yy
DCN
1
mm/dd/yy
YY-nnn
What changed?
Why did it change?
Author
Initial release
-
B Glass
6. RESPONSIBILITIES AND AUTHORITIES
Role
Responsibilities and Authorities
PMS Process Owner
Responsible for ensuring that PMS Plans are prepared and followed, and for
calling PMS Review meetings as required.
7. PROCEDURE
1. PMS PLANNING
Refer to Flowchart 1.
1
The transfer of the Clinical Evaluation File and the Risk File from a product development project to the
PMS File is planned in the Product Development Plan, according to SYS-008 Product Development
Procedure. Typically the PMS Plan for each product is initiated after the approval of design outputs
(i.e., “design freeze”) and the PMS Plan is approved at the end of the design transfer process along with
commercial release of the product. The risk management plan for post-commercial launch is also
typically included as part of the PMS Plan.
2
Individual PMS documents are controlled according SYS-001 Document Control. The files are indexed
from their key documents. A PMS File for a product or product family is indexed using the PMS Plan
and the PMS Reports.
3
The following elements should be considered in the preparation of the PMS Plan for a product or
product family:







Information from research and development activities, within [Company Name] or at any
contract designer;
Information from servicing and customer training personnel within or contracted by
[Company Name];
Information from users of the products, including customer complaints and any other means
by which feedback may be sought, e.g. customer surveys;
Information relating to market experience of similar products or products with similar
intended use, e.g. from regulatory registers or incident databases;
Frequency and nature of clinical evaluation, e.g. post-market clinical studies or published
literature;
Information on new or amended standards, regulations, regulatory guidances;
For products with a drug component, drug related information.
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2. PMS REPORT AND REVIEW
Refer to Flowchart 2.
1
Complaint data for all products is reviewed on a regular basis to determine if corrective actions should
be initiated. Typically this is done on a monthly basis, but this should be done at least quarterly and
must be reviewed as part of the inputs to the Management Review process (SYS-003).
2
PMS Review meetings are scheduled according to the PMS Plan as documented in LST-010. Typically
this is performed quarterly, but this should be done at least annually. The frequency of PMS review
may change in accordance with the amount of clinical history available for the product and similar
products on the market. PMS reports are the output of the PMS Review meetings. PMS reports should
include a conclusion that indicates if the PMS Plan should be updated to reflect if the frequency of
PMS review should be changed (i.e., more frequent, less frequent or no change).
The function of the PMS Review meeting is to discuss and approve draft PMS reports prepared prior to
the meeting. The attendees should also determine if any actions should be taken in response to PMS
trends—including complaints. This report must be reviewed as part of the inputs to the Management
Review process (SYS-003).
3
A PMS Report may raise an issue that requires immediate action (e.g., it may identify a previously
unidentified potential for serious injury or death). In this instance a CAPA should be initiated
immediately.
4
The PMS Report may identify new hazards or recommend changes to the likelihood or severity of harm
associated with a known hazard. This new information should be reflected in the risk management
table. These may then require a new assessment of risk controls and residual risks, including the overall
residual risk for the product, which may require update of the Risk Management Report. It may also be
required to update the Clinical Evaluation Report.
5
A Clinical Evaluation Report for a product, prepared using a prospective protocol, is described in SYS009 Clinical Procedure. Any Complaint data since the past Clinical Evaluation should be reviewed and
any PMS reports created since the previous Clinical Evaluation Report should be included as an input.
The PMS Plan for a product prescribes the frequency with which a new Clinical Evaluation Report
must be prepared. Frequency may vary between six-months for a recently released, unfamiliar product
to five-years for a mature product. An initial Clinical Evaluation Report must be completed prior to
product launch.
6
For low-risk and medium-risk products that are equivalent to existing products on the market with a
known clinical history, clinical studies are not typically performed as part of pre-market design
validation. However, there is an expectation to consider the need for Post-Market Clinical Follow-up
(PMCF) Studies for these products in accordance with MEDDEV 2.12/2. If a PMCF Study is needed,
the protocol should be included with the PMS Plan and the PMCF Report should be included with PMS
Reports. If there is a justification for not performing PMCF Studies, then this should be documented in
the PMS Plan and linked with the Risk Management Report and Clinical Evaluation Report.
Specifically, there should be a justification that addressed each of the residual risks. Residual risks that
typical require PMCF Studies include:




7
risks associated with a broader patient population,
risks associated with a broader user population,
risks associated with new indications for use, and
risks associated with new accessories which may or may not be provided with the device.
For high-risk products, clinical studies are typically performed as part of the pre-market design
validation. These clinical studies will be performed in accordance with SYS-009 Clinical Procedure
and the results will be included in the Clinical Evaluation Report.
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8. MONITORING AND MEASUREMENTS
Post-market surveillance is in itself a monitoring and measuring procedure which feeds into Management Review.
Monitoring and measuring aspects are therefore described as part of the procedure.
9. TRAINING/RETRAINING
Role
Training or Retraining Required
PMS Process Owner
Shall be trained and be competent in all aspects of this procedure.
Any person required to
prepare a PMS Plan or PMS
Report
Shall be trained in all aspects of this procedure at the time that they first need to
apply them, by the PMS Process Owner.
Attendees at PMS Review
Meetings
Shall be trained and have a general understanding of this procedure, and be
competent in those aspects related to PMS Review.
10. RISK MANAGEMENT
Hazard
Risk control measures
1.
Actual or potential product safety issues that
arise post-market are not identified.
Systematic analysis to identify actual or potential product
safety issues.
2.
Action is not taken on product safety issues
that become apparent after a product is
placed on the market.
Serious issues are dealt with immediately via SYS-018
(Feedback and Complaints), SYS-020 (Field Action)
New hazards that are identified post-market
(or post-production), or information that
might impact on assessment of severity or
likelihood of hazards, is not transferred to
the product Risk File.
Integrate post-market maintenance of the Risk File into the
PMS procedure.
3.
Issues identified from PMS analysis are reviewed and
transferred to CAPA when appropriate.
11. RECORDS
Record
Description
Storage and Retention
PMCF Protocol
Post-Market Clinical Follow-up Protocol
prospectively approved and executed in
accordance with the PMS Plan for each
product or product family.
Stored as scanned pdfs in standard
Records location. Retained
indefinitely.
Post-Market Clinical Follow-up Report
summarizing the results of an executed
PMCF Protocol.
Stored as scanned pdfs in standard
Records location. Retained
indefinitely.
PMCF Report
Forms part of the PMS File
Forms part of the PMS File
PMS Plan, (PMS-nnn)
Document outlining the plan for
conducting PMS for a product or
product family.
Stored as scanned pdfs in standard
Records location. Retained
indefinitely.
Forms part of the PMS File
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Record
Description
Storage and Retention
PMS Report, (PMS-nnn)
Report which is the output of PMS.
Stored as scanned pdfs in standard
Records location. Retained
indefinitely.
Forms part of the PMS File
PMS File
12. FLOWCHARTS
Conceptual file which includes all
documents in category PMS plus Risk
and Clinical Evaluation Files
Conceptual file. Storage for
components defined separately.
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