Manufacturer’s Periodic Summary Report (PSR) Form

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1. Administrative information

To which NCA(s) is this report being sent?

Date of this report

Reference number assigned by the manufacturer

Reference number assigned by NCA

Type of reportFollow-up report

Follow up Number

2. Information on submitter of the report

Status of submitterManufacturer
Authorised Representative within EEA, Switzerland and Turkey
Others

Identify the role:

3. Manufacturer information

Name

Contact name

Address

City

Postcode

Phone

Fax

E-mail

Country

4. Authorised Representative information

Name

Contact name

Address

City

Postcode

Phone

Fax

E-mail

Country

5. Submitter´s information (if different from section 3 or 4)

Submitter’s name

Contact name

Address

City

Postcode

Phone

Fax

E-mail

Country

6. Medical device information

Class

AIMD Active implants
MDD Class III
MDD Class IIb
MDD Class IIa
MDD Class I

IVD Annex II List A
IVD Annex II List B
IVD Devices for self-testing
IVD General

Nomenclature system (preferable GMDN)GMDN
UMDNS (ECRI)
EDMS

Nomenclature code

Nomenclature text

Notified Body (NB) ID-number

Model number(s) or Family Name

Catalogue number(s)

7. PSR Information

PSR Type Incidents described in a Field Safety Notice
Common and well documented incidents

Manufacturers reference number for FSN / FSCA

Stage of PSR reporting based onObserved Failure mode
Root cause

Nature of problem agreed for PSR reporting

Summary period agreedEvery month
Every 2 months
Every 3 months
Every 6 months
Every 12 months

The figures in the table below relate toEEA+CH+TR
All PSR recipients NCA’s identified in Section 1
Single Member State

Please name:

Date of PSR

New incidents this period

Total number incidents via PSR

Total number resolved

Total number in progress

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8. Manufacturer's comments / investigation results

Investigation update for this period

Initial corrective actions / preventive actions implemented by the manufacturer

Recommended actions for this period, if any

Expected date of next PSR report

9. Distribution

The medical device has been distributed to the following countries

Within EEA, Switzerland and Turkey

All EEA, Switzerland and Turkey

Others:

10. Comments

Comments