Post Market Surveillance

Post market issues may be identified through a variety of sources, including analysis of adverse event reports, a recall or corrective action, reports from other governmental authorities, or the scientific literature. Post Market Surveillance (PMS) activities is the systematic collection of data on the performance of products during the post marketing phase exist in different countries ISO13485 Clause 5.4.2

6. Abbreviations

QMS - Quality Management System

SOP – Standard Operating Procedure

PMS – Post Market Surveillance

MD – Managing Director

NCCA – Non Conformance Corrective Action

7. References

ISO13485 Clause 4.2

PROCEDURE FOR PREVENTIVE AND CORRECTIVE ACTION AND HANDLING OF NONCONFORMING PRODUCT

8. Procedure

1. PMS is intended that Post market surveillance is performed for any product of the manufacturer where the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be:

implanted in the human body for more than one year, or
a life sustaining or life supporting product used outside a product user facility.
the company have nominated to also include Sterile products.

2. As PMS is the role of a manufacturer, it is through FEEDBACK arrangements by the distributor, through the supplier agreement, that the Distributor contributes to market information to the manufacturer

3. Attach any reports in the Google DRIVE as applicable

8.1 PMCF (MEDDEV 2.12-2 Rev. 2)

PMCF required possibly under the following circumstances:

• Novel medical technology

• High product-related risk

• High-risk anatomical locations

• High-risk target populations (e.g. children, elderly)

• Severity of disease/treatment challenges

• Unanswered questions of long-term safety and performance

• Identification of previously unstudied subpopulations which may exhibit different benefit/risk-ratio (i.e. hip implants in different ethnic populations)

• Verification of safety and performance of the product when exposed to a larger or a more varied population of clinical users

At minimum, postmarket surveillance system (PMS) should include formal documentation of:

• How to collect the information from data sources

• Methodology for assessing data (Reference Data Analysis SOP ISO13485 8.4)

• Rationale used for risk analysis (ISO13485 4.1.2 b)

• Methods for receiving and investigating complaints (reference Complaints handling SOP ISO13485 8.2.2)

• Methods for determining trends (Reference Data Analysis SOP ISO13485 8.4)

• Procedure for communicating with authorities where needed (refer ISO13485 8.2.3)

• Product tracing methods (refer Traceability SOP ISO13485 7.5.9)

• Any actions you have taken as a result of PMS (refer Improvement SOP ISO13485 8.5)

A postmarket surveillance plan is a systematic process that is designed for the monitoring of a specific product. PMS plan to define;

a) which data should be reviewed,

b) how it should be collected, and

c) how you will investigate or determine reportable trends.

The type of data collected should cover:

• Investigations of both serious and non-serious incidents

• Reports of undesirable side effects

• Analysis of trends

• Feedback from users, distributors, or importers—including complaints

• Publicly available information about similar products, as well as relevant information from literature, databases, or other sources.

PMS plan to address the processes used to collect data and the methods used to assess the collected data, including the methods, protocols, or tools used for activities such as:

• Investigating complaints and other market feedback

• Identifying and analyzing reportable trends

• Identifying and initiating corrective actions

• Tracing and identifying products that require corrective action

PMS plan to enable,

a) monitoring for any adverse events as well as gathering data on the long-term safety and effectiveness of the product

b) information to gather meaningful feedback from end users, discover data trends, and make informed decisions on any updates or iterations to your product.

Enables include

1. Activity triggers. time-based (annually for high risk and) or prompted by a specific activity (only performed when high volume of complaints or incidents are recorded).

2. A list of information sources. includes customer feedback, service reports, employee observations, clinical follow-up studies, assessment results, feedback from exhibitions or training and any other source of good information.

3. PMS activities. stage 1 write a protocol (plan), stage 2 collect data and tabulate, stage 3 analyse using statistical techniques and stage 4 evaluate data to determine positive and negative results that may require action to be taken as a non-conformance, corrective action or preventive action.

4. Roles and responsibilities for PMS activities. Record who is responsible for what within your PMS system with specific information when describing the activities assigned to each role.

5. Documentation of PMS plan and activities. PMS plan to be documented and recorded and the need to provide evidence of the various activities followed and data collected and reported

POSTMARKET SURVEILLANCE REPORT (PMSR) & PERIODIC SAFETY UPDATE REPORT (PSUR)

Class I device in Europe, MDR to create a Postmarket Surveillance Report (PMSR), is to provide a summary of the results and conclusions of your PMS data, as well as a rationale and description of any corrective actions taken as a result of PMS activities.

Class IIa, IIb, and III devices, the MDR requires a Periodic Safety Update Report (PSUR), an extension of the PMSR. The PSUR contains a summary of PMS results and conclusions as well as a summary of postmarket information, vigilance reporting, and the current status of the device on the market.

PSUR includes the rationale for any corrective or preventive actions:

• Conclusions of risk-benefit determination

• Main findings of postmarket clinical follow-up

• Sales volume of the device

• Estimates of the size of other characteristics of the user / customers using the device (plus usage frequency if known).

Postmarket clinical follow-up (PMCF) is a proactive form of surveillance that systematically gathers clinical data on how the device is used and the outcomes of that use. It is concerned with ensuring the real-world use of a device is accurately characterized; if not done then the absence must be justified in PMS plan.

High-risk devices require postmarket clinical follow-up

Low or moderate-risk devices may have residual risks that could benefit from a PMCF.

All PMCF studies should include:

• Clearly stated objective(s)

• Scientifically sound design with an appropriate rationale

• Logical study plan and implementation

• Appropriate statistical analysis of data, interpretation, and conclusion

9. Risk Based Approach

In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document]

9.1 Trend Analysis and Continual Improvement

The analytical reviews of internal audits, and any other quality related matters, are reported through Data Analysis to management and as part of the input to management review.

The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.

Corrective actions identified during the evaluation will be documented via the PROCEDURE FOR PREVENTIVE AND CORRECTIVE ACTION AND HANDLING OF NONCONFORMING PRODUCT SOP. Based on the findings of the report, it may be necessary to update the relevant products risk management modules & technical files

10. REVISION HISTORY

Revision 4; AA & SCR 24.05.2022 - inclusion of medicines GWP

Revision 3; TNA 24.08.2021 - Addition of Item 8.1

Revision 2; AA 19.08.2021 - Updating Information

Revision 1; new 01.07.2021

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

PMS (DRIVE) Google Drive indefinite n/a