Periodic Safety Update Report (PSUR) For (Device Name) : Company Logo

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

{Company Logo}

1.0

PERIODIC SAFETY AND UPDATE REPORT

TABLE OF CONTENT

SECTION

TITLE

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

Report. ID?

{Issue / Revision Number as per your QMS}

PAGE NO.

Page 2 of 11

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2.0

PERIODIC SAFETY AND UPDATE REPORT

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}

Models /Variants

1. 2. 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

Report. ID?

{Issue / Revision Number as per your QMS}

Page 3 of 11

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PERIODIC SAFETY AND UPDATE REPORT

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.

Report. ID?

{Issue / Revision Number as per your QMS}

Page 4 of 11

PERIODIC SAFETY AND UPDATE REPORT

{Company Logo}

6.0

PMS SUMMARY

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

Report. ID?

{Issue / Revision Number as per your QMS}

Page 5 of 11

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6.1

PERIODIC SAFETY AND UPDATE REPORT

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 Profile Reference No.

>>> Benefit risk ratio determination document number from risk 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?

Report. ID?

{Issue / Revision Number as per your QMS}

Page 6 of 11

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PERIODIC SAFETY AND UPDATE REPORT

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 Performance

Provide the performance of the device from PMCF

Report. ID?

{Issue / Revision Number as per your QMS}

Page 7 of 11

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PERIODIC SAFETY AND UPDATE REPORT

Clinical Benefit of Device

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

EMC Safety

Mention the electromagnetic compatibility Safety (EMC) applicable for electrical device.

Electrical Safety

Provide the electrical safety data

Medicinal Safety

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

Compatibility of device with another device

Provide Any compatibility of device with other device

Newly Identified Side-Effects

Provide identified side effects

Provide new contraindications if any identified apart from IFU

Contraindications

Report. ID?

{Issue / Revision Number as per your QMS}

Page 8 of 11

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PERIODIC SAFETY AND UPDATE REPORT

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

Provide the information on sales

Country C1

Country C2

Country C3

Country C4

Remarks

of the device throughout the world

Report. ID?

{Issue / Revision Number as per your QMS}

Page 9 of 11

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6.4

PERIODIC SAFETY AND UPDATE REPORT

Evaluation of Target Population

Estimated Population Size

Provide estimate number of populations using the device

Characteristics of the population

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

Estimated Usage Frequency

Provide details of usage frequency of the device , if applicable

Report. ID?

{Issue / Revision Number as per your QMS}

Page 10 of 11

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7.0

PERIODIC SAFETY AND UPDATE REPORT

CONCLUSION

Is the device safe and sale can be continued in market

Yes

No

Any warnings / caution to be added in user information of the device. (if yes provide the detail)

Yes

No

8.0

CONTACT PERSON DETAILS

Contact person for PSUR: Designation

Contact Details

Signature

Report. ID?

{Issue / Revision Number as per your QMS}

Page 11 of 11