Company Logo

PERIODIC SAFETY UPDATE REPORT

(PSUR)
For
[DEVICE NAME]

PSUR NO.

PSUR Date

CE Certificate No

CE Certificate Validity

Procedure Number

Manufacturer Name & Address

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1.0 TABLE OF CONTENT

SECTION TITLE PAGE NO.

1.0 TABLE OF CONTENT

2.0 INTRODUCTION

3.0 MEDICAL DEVICE INFORMATION

4.0 CLASSIFICATION AND RULE OF THE MEDICAL DEVICE

5.0 UPDATE FREQUENCY

6.0 PMS SUMMARY

6.1 BENEFIT-RISK DETERMINATION

6.2 PMCF OUTPUTS

6.3 DEVICE SALES

6.4 EVALUATION OF TARGET POPULATION

7.0 CONCLUSION

8.0 CONTACT PERSON DETAILS

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2.0 INTRODUCTION

This Periodic Safety Update Report (PSUR) No. X for XXXXX covers the period from 01-XXX-201X to 31-XXX-201X. It
is based on all available cumulative data since the marketing date (XX.XX.XXXX) and is focused on new information
which has emerged since 01-XX-201X.

3.0 MEDICAL DEVICE INFORMATION

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}

1.
2.
Models /Variants 3.
4.

UDI_DI:

Intended use {Outline the manufacturer’s intended use of the device as per
technical file}

Target population { user population defined for the device, if any}

Medical Indications {Provide the medical indications of the device as per IFU}

Marketing Start Date

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Notified Body Name:

Notified Body Number:

CE Marking Status:

Date of Market Introduction:

EU Representative Name & Address

4.0 CLASSIFICATION AND RULE OF THE MEDICAL DEVICE

Class:

IIa Class IIb Class III

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

5.0 UPDATE FREQUENCY

☐Class II a – Update every two years

☐Class II b (Non implantable) – Annually updated

☐Class IIb (Implantable)- Annually updated

☐Class III – Annually updated.

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6.0 PMS SUMMARY

please mention the PMS no. date and summary based on the PMS plan and report

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6.1 Benefit – Risk Determination Summary

This table includes the analysis of all benefits and risks relevant to the device under evaluation, when used
as indicated by the manufacturer and to determine if the benefits outweigh the risks.

>>> Benefit risk ratio determination document number from risk

Benefit – Risk Profile Reference No.
management >>

Benefits observed {Provide the benefits observed from RMS files}

Any risk observed (if yes explain its severity, probability and its acceptance){Provide the
risks observed from RM files}

Do the device benefits outweigh the

risks identified?

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Do risk control measures are

sufficiently provided (if yes explain with respect to risk)

Overall % of Device Benefits

6.2 PMCF Summary

Below table summarized the clinical safety and performance of a device when used in accordance with its
approved labelling.

PMCF Study Details:

Include the study details, no. of study centres, study methods used, etc

PMCF Study Period:

Device Safety Provide the safety of the device from PMCF

Device Performance / Software

Provide the performance of the device from PMCF
Performance

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Any Clinical benefit of the device. Type of benefit – life saving,

Clinical Benefit of Device
probability

Mention the electromagnetic compatibility Safety (EMC) applicable

EMC Safety
for electrical device.

Electrical Safety Provide the electrical safety data

Mention the safety of the medicine part if the device is a drug device
Medicinal Safety
combination

Compatibility of device with another

Provide Any compatibility of device with other device
device

Newly Identified Side-Effects Provide identified side effects

Provide new contraindications if any identified apart from IFU

Contraindications

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Emergent Risks Provide newly identified risks apart from RMF.

Any Misuse or Off-Label Use of Device Provide misuse or Off-Label Use

PMCF Analysis and Conclusions:

Include summary of the evaluation report, CAPA generated and the actions done.

6.3 Device Sales

Volume of Sales

Country Country Country Country

Remarks
Provide the information on sales C1 C2 C3 C4

of the device throughout the

world

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6.4 Evaluation of Target Population

Estimated Population Size Provide estimate number of populations using the device

Please explain any characteristics of the population for eg: adult with
Characteristics of the population
age 15- 50 or Nulliparous women etc.

Estimated Usage Frequency Provide details of usage frequency of the device , if applicable

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7.0 CONCLUSION

Is the device safe and sale

Yes No
can be continued in market

Any warnings / caution to

be added in user
Yes No
information of the device.
(if yes provide the detail)

8.0 CONTACT PERSON DETAILS

Contact person for PSUR:

Designation

Contact Details

Signature

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