{Company Logo} PSUR ACTION PLAN AND FOLLOW UP

Report ID

Effective Date

1.0 INTRODUCTION

This document helps to solve the non-conformities found in Periodic Safety Update Report.

Medical Device Name {Provide the name of the device as per the Technical File}

Brand Name(s) {Provide the brand name of the device as per the Technical File}

PSUR NO.

PSUR Date

CE Certificate No

CE Certificate Validity

Notified Name and Address

Competent Authority name and

Address, if applicable

Class:

IIa Class IIb Class III

Rule: {Enter the rule of the device as per EU MDR}

2.0 PMS SUMMARY

Report. ID? {Issue / Revision Number as per your QMS} Page 1 of 6
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>>>>According to each non-conformity the table can be repeated>>>>>

Mention the nonconformity/ new risk observed in the pms data as per the
Non-Conformity Observed
notified body

Root Cause Analysis Mention the root cause analysis or the describe the reason for the NC

Action Planned Plan the corrective action and time period to complete the same

Implemented correction What is the implemented correction and time?

Evidence for the

implantation of Corrective Mention the report or the document showing as evidence for the correction
Action

2.1 Benefit – Risk Determination Summary

Report. ID? {Issue / Revision Number as per your QMS} Page 2 of 6

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Benefit – Risk Profile >>> Benefit risk ratio determination document number from risk management
Reference No. >>

Mention the nonconformity in risk benefit ratio/ analysis data as per the
Non-Conformity Observed
notified body

Root Cause Analysis Mention the root cause analysis or the describe the reason for the NC

Action Planned Plan the corrective action and time period to complete the same

Implemented correction What is the implemented correction and time?

Evidence for the

implantation of Corrective Mention the report or the document showing as evidence for the correction
Action

2.2 PMCF Summary

Report. ID? {Issue / Revision Number as per your QMS} Page 3 of 6

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PMCF Evaluation Report No.

Mention the nonconformity in PMCF data/ new risks as per the

Non-Conformity Observed
notified body

Root Cause Analysis Mention the root cause analysis or the describe the reason for the NC

Action Planned Plan the corrective action and time period to complete the same

Implemented correction What is the implemented correction and time?

Evidence for the implantation of Mention the report or the document showing as evidence for the
Corrective Action correction

3.0 SUMMARY OF ACTION PLAN

Report. ID? {Issue / Revision Number as per your QMS} Page 4 of 6
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SL No. Responsible
Nonconformities Status Signature
Person

4.0 APPROVAL

Report. ID? {Issue / Revision Number as per your QMS} Page 5 of 6

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Contact person for PSUR:

Designation

Contact Details

Signature

Report. ID? {Issue / Revision Number as per your QMS} Page 6 of 6