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. The approach is to convene an expert review team to identify the objective, the information that is needed to achieve the objective, appropriate sources, and mechanisms for obtaining this information, and facilitate necessary actions

Post Market Surveillance (PMS) activities is the systematic collection of data on the performance of devices during the post marketing phase exist in different countries ISO13485 Clause 5.4.2

Principal – legal manufacturer of the medical device; company name labelled of the medical device

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

ADVERSE EVENTS AND RECALL

MANAGEMENT REVIEW

REGULATORY CONTROL

DATA ANALYSIS

8. Procedure

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

a. implanted in the human body for more than one year, or

b. a life sustaining or life supporting device used outside a device user facility.

c. the company have nominated to also include Sterile products.

The following PMS FORM is to be completed and the PMS RECORD SHEET populated as a record

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. Appointment of a PSO must be in writing , who should fulfil the following conditions.

a. have suitable subject knowledge of the device

b. have Practical experience in monitoring and follow-up adverse side effects, clinical studies and clinical pharmacy Reports

c. required to provide a regulatory authority with supporting experience, in addition to full contact details and address (office tel.,Mobile, email)

4. The following are guidelines for initiation of Post-Market Surveillance evaluation.

a. New or expanded conditions of use for existing devices

b. Post Market surveillance may be required to augment premarket data to obtain more experience with change from hospital use to use in the home or other environment or with new patient populations.

c. Significant changes in device characteristics (technology)

d. Questions that arise from significant or developmental changes to device technology that can be most appropriately addressed in the Post Market period. There may be concerns that changes in the technology of a device may affect the duration of the effectiveness of the device, which could be addressed by Post Market surveillance. In these situations, Post Market surveillance, through collection of longer-term safety and effectiveness data, may augment premarket data and allow earlier marketing of new technologies without compromising the public health.

e. Longer term follow-up or evaluation of rare events

f. Post Market surveillance is done to address longer term or less common safety and effectiveness issues of implantable and other devices for which the premarket testing provided only limited information. For example, premarket evaluation of the device may have been based on surrogate markers. Once the device is actually marketed, Post Market surveillance may be appropriate to assess the effectiveness of the device in detecting or treating the disease or condition, rather than the surrogate. Data collected during Post Market surveillance may include rates of malfunction or failure of a device intended for long-term use or incidents of latent sequelae resulting from device use.

g. Public health concern(s) resulting from reported or suspected problems in marketed devices

h. Post Market surveillance may be done to better define the association between problems and devices when unexpected or unexplained serious adverse events occur after a device is marketed; if there is a change in the nature of serious adverse events (e. g., severity); or if there is an increase in the frequency of serious adverse events.

5. Post-Market Surveillance evaluation is done by a review team, which includes, but is not limited, to a representative from marketing, Production, QA, as relevant, the report is completed and sent to the PSO for approval and recommendation

a. Information is collated from marketing and local markets complaint reports, adverse incident reports, production and marketing material and publications

b. The PSO will develop any safety alerts, public health notifications and other publications about suspected device problems and distributing them to the public as required – the communication is established (letters, e-mails, notices are developed by the PSO and the Country Manager.)

c. types of information & feedback that may be incorporated into the evaluation:

i. customer complaints

ii. review of product claims & labelling

iii. post CE-market clinical trials or cohort studies (if conducted)

iv. literature reviews

v. detection of manufacturing problems & lab / QC test results

vi. knowledge of long-term performance / reliability and / or chronic complications

vii. feedback on training needs for users or user reactions during training

viii. feedback on customer satisfaction / perception

ix. medical device vigilance reporting of the specific device

x. knowledge of the ways in which the device is misused

xi. experience with similar devices or competitor products

d. The PSO will prepare a Post Safety Update Report (PSUR), as required, with topics not limited to the following as a guideline,

i. Executive Summary

ii. Introduction

iii. Worldwide Marketing Authorisation Status

iv. Update on Actions Taken for Safety Reasons

v. Changes to Reference Safety Information

vi. Inventory and Status of Ongoing and Completed Interventional Clinical Trials

vii. Estimated Patient Exposure in Clinical Trials

viii. Presentation of Safety Data from Clinical Studies

ix. Significant Findings from Interventional Clinical Trials

x. Observational and Epidemiological Studies

xi. Information from Marketing Experience

xii. Overall Safety Evaluation

xiii. Summary of Important Risks

xiv. New Actions Recommended

xv. Other Information

xvi. Conclusions

xvii. Appendices to PSU

6. The post-market surveillance evaluation will be filed with the relevant medical device’s technical documentation.

a. Corrective actions identified during the evaluation will be documented via the SOP non-conformance reporting system. Based on the findings of the report, it may be necessary to update the relevant devices risk management documents & technical files and / or an adverse event may be identified where SOP Adverse Events and Recalls is followed.

b. Trend Analysis and Continual Improvement,

i. An analytical review is reported monthly to management and this forms part of the input to SOP Management Review,

ii. The Trend should pick up any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement,

7. Attach any reports in the Google Drive as applicable

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 devices risk management modules & technical files

10. REVISION HISTORY

Revision 2 NG 25.02.2025 Under Definitions removed pharmacovigilance as not relevant. Pharmacovigilance removed from 8.4, 8.5 and 8.6.

Revision 1 New HJM 5.09.2024

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

PMS FORM Google Site Indefinite n/a

PMS RECORD SHEET Google site Indefinite n/a

Post Market Surveillance Officer Appointment Google Site Indefinite n/a

Page updated

Google Sites

Report abuse