Manufacturer Incident Report (MIR) for

Serious Incidents (MDR/IVDR)

Reporting Template Version: 7.3.1
European Union Medical Devices Vigilance System
(SB-10407)

Section 1: Administrative information

1.1 Responsible competent authority in which country the incident occurred
a Name of receiving national competent authority (NCA)

b EUDAMED number of NCA

c Reference number assigned by NCA for this incident

d Reference number assigned by EUDAMED for this incident

1.2 Date, type, and classification of incident report

Date of report submission Date of incident
a b to
in format YYYY-MM-DD in format YYYY-MM-DD

Manufacturer awareness date of the incident Manufacturer awareness date of reportability

c d in format YYYY-MM-DD
in format YYYY-MM-DD

e Type of report
Initial
Follow up
Combined initial and final
Final (Reportable incident)
Final (Non-reportable incident)
In case of initial and follow-up reports, please indicate the expected date of the next report
f in format YYYY-MM-DD

g Classification of serious incident

Serious public health threat
Death
Unanticipated serious deterioration in state of health
All other reportable incidents

1.3 Submitter information

1.3.1 Submitter of the report
a
Manufacturer Authorised representative Other, please specify
b Manufacturer's reference number for this incident
 c If this incident involves multiple devices from the same manufacturer, please list the respective reference
numbers of the other MIR forms you have submitted
- NCA's local reference number
- EUDAMED's reference number
- Manufacturer's reference number
d If this incident is covered under a FSCA, please provide the relevant numbers:
- NCA's local FSCA reference number
- EUDAMED's FSCA reference number
- Manufacturer's FSCA reference number
e Periodic Summary Report (PSR) ID

f The incident occurred within a PMCF/PMPF investigation

yes no

1.3.2 Manufacturer information

a Manufacturer organisation name

b Single registration number

c Contact’s first name d Contact’s last name

e Email f Phone

g Country

h Street i Street number

j Address complement k PO Box

l City name m Postal code

1.3.3 Authorised representative information

a Authorised representative organisation name

b Single Registration Number

c Contact’s first name d Contact’s last name

e Email f Phone

g Country
 h Street i Street number

j Address complement k PO Box

l City name m Postal code

1.3.4 Submitter’s details if not also manufacturer or authorised representative

a Registered commercial name of company

b Contact’s first name c Contact’s last name

d Email e Phone

f Country

g Street h Street number

i Address complement j PO Box

k City name l Postal code

Section 2: Medical device information
2.1 Unique Device Identification (UDI)
(Master) UDI-DI/Eudamed ID Unknown UDI production identifier Unknown
a b
Issuing entity

Basic UDI-DI/Eudamed-DI Unknown Unit of use UDI-DI

c d
Issuing entity Issuing entity

2.2 Categorisation of device

a Medical device nomenclature
if other, please specify
b Medical device nomenclature code

2.3 Description of device and commercial information

a Medical device name (brand/trade /proprietary or common name)

b Description of the device and its intended purpose Nomenclature text

c Model d Catalogue/reference number

e Serial number f Lot/batch number

g Software version h Firmware version

i Device manufacturing date j Device expiry date

in format YYYY-MM-DD in format YYYY-MM-DD

k Date when device was implanted l Date when device was explanted
to in format YYYY-MM-DD to in format YYYY-MM-DD

m If precise implant/explant dates are unknown, provide the duration of implantation

Number of years Number of months Number of days
n Implant facility o Explant facility

p Notified body (NB) ID number(s) (if applicable) Notified body (NB) certificate number(s) of device (if applicable)
1

2
q Please indicate the date of one of the following:
First declaration of conformity
The device first CE marked
First placed on the market Year Month
First put into service
If software, date first made available
2.4 Risk class of device when placed on market
a Applicable legislation unknown

b This device has been placed on the market before the implementation of the MDD/AIMDD/IVDD

MDD/AIMDD IVDD

c active implant class IIa class Im IVD Annex II List A IVD devices for self-testing
class III class I class Ism IVD Annex II List B IVD general
class IIb class Is custom-made
MDR Type (Multiple choice) IVDR Type (Multiple choice)
class III implantable software class D self-testing
class IIb active device systems class C near-patient testing
class IIa intended to administer and /or custom-made class B companion diagnostic
d class I remove a medicinal product procedure packs class A professional testing
sterile conditions non-medical purpose reagent
measuring function software
reusable surgical instruments instrument
sterile conditions
e Did this device continue to be placed on the EU market after MDR / IVDR date of application? Yes No

Does the device fulfil any of the following cases:

- “for this device a scientific opinion has been asked in accordance with Article 52(9) MDR or Article 52(10) MDR”,
- “for companion diagnostic a competent authority or European Medicines Agency (EMA) was consulted in
accordance with section 5.2 of Annex IX IVDR or section 3.k of Annex X IVDR."
Yes No
f
Competent authority name or European Medicines Agency which delivered the scientific opinion or was consulted
by the notified body

Name(s) of the medicinal substance(s) / product(s), tissue(s), cell(s) of human origin or their derivative(s)
associated with the device

2.5 Market distribution of device (region/country)

All EEA, Turkey and Northern Ireland
AT BE BG CY CZ DE DK EE ES FI FR GR HR

a HU IE IS IT LI LT LU LV MT NL NO PL PT
RO SE SI SK TR XI
The code XI is used for Northern Ireland
Others:

2.6 Use of accessories, associated devices or other devices

Relevant accessories used with the device being reported on (please list with corresponding Manufacturer if
a
different from device being reported on)

Relevant associated devices used with the device being reported on (please list with corresponding Manufacturer
b
if different from device being reported on)
Section 3: Incident information derived from initial reporter
(healthcare professional/facility/patient/lay user/other)
3.1 Nature of incident
a Provide a comprehensive description of the incident, including (1) what went wrong with the device (if applicable)
and (2) a description of the health effects (if applicable), i.e. clinical signs, symptoms, conditions as well as the
overall health impact (i.e. Death; life-threatening; hospitalization – initial or prolonged; required intervention to prevent permanent
damage; disability or permanent damage; congenital anomaly/Birth defects; indirect harm; no serious outcome)

3.2 Medical device problem information

a IMDRF Medical device problem codes (Annex A)
Coding with IMDRF terms is a mandatory requirement.
Choice 1 Choice 2 Choice 3 Choice 4 Choice 5 Choice 6
(most relevant)
IMDRF 'Medical device Code Code Code Code Code Code
problem codes'

If exceptionally no relevant IMDRF code is available or specific enough, then provide additional information below

b Number of patients involved

c What is the current location of the device?

Healthcare facility/carer Distributor
Patient/user Discarded
In transit to manufacturer Remains implanted
Manufacturer Unknown Other:

d Operator of device at the time of the incident

Healthcare professional Patient/lay user Other, please describe

e Usage of device (as intended)

Initial use Reuse of a single use medical device
Reuse of a reusable medical device Re-serviced/refurbished/fully refurbished
Problem noted prior use Other:

f Remedial actions taken by healthcare facility, patient or user subsequent to the incident
3.3 Clinical information
a IMDRF 'Health Effect' terms and codes (Annex E, F)
Coding with IMDRF terms is a mandatory requirement.

Choice 1 Choice 2 Choice 3 Choice 4 Choice 5 Choice 6

(most relevant)
IMDRF 'Clinical signs, Code Code Code Code Code Code
symptoms, and conditions
codes' (Annex E)
IMDRF 'Health impact' Code Code Code Code Code Code
codes (Annex F)

If exceptionally no relevant IMDRF code is available or specific enough, then provide additional information below

Age of patient at the time of the incident

b
years months days
c Gender Female Male Other Not specified

d Body weight (kg) e Height (cm)

f List any of the patient's prior health condition or medication that may be relevant to this incident

3.4 Initial reporter

a Role of initial reporter
Healthcare professional Patient Lay user Other, please specify
b Name of healthcare facility where incident occurred

c Healthcare facility report number (if applicable)

d Contact’s first name e Contact’s last name

f Email g Phone

h Country
if other, please specify
i Street j Street number

k Address complement l PO Box

m City name n Postal code

Section 4: Manufacturer analysis
4.1 Manufacturer’s preliminary comments
a For initial and follow-up reports: preliminary results and conclusions of manufacturer’s investigation

Suspicion of a relationship between the incident and the medicinal substance(s) / product(s), tissue(s), cell(s) of
human origin or their derivative(s) associated with the device?
b
Yes No

c Initial actions (corrective and/or preventive) implemented by the manufacturer

d What further investigations do you intend in view of reaching final conclusions?

4.2 Cause investigation and conclusion

For Final (Serious incident): Description of the manufacturer’s evaluation concerning possible root causes
a
/causative factors and conclusion

b For Final (Non-reportable incident): Fill out rationale for why this is considered not reportable

Is root cause confirmed?

Yes No
c Suspicion or confirmation of a relationship between the serious incident and the medicinal substance(s) /
product(s), tissue (s), cell(s) of human origin or their derivative(s) associated with the device?
Yes No

Has the risk assessment been reviewed ?

d
Yes No If 'No', rationale for no review required:

If the risk assessment has been reviewed, is it still adequate?

Yes No
Results of the assessment:
 IMDRF ‘Cause Investigation' terms and codes (Annex B, C, D)

e Coding with IMDRF Choice 1 Choice 2 Choice 3 Choice 4 Choice 5 Choice 6 Choice 7 Choice 8
terms is a mandatory (most relevant)
requirement.
IMDRF Cause Code Code Code Code Code Code Code Code
investigation: Type
of investigation
(Annex B)

IMDRF Cause Code Code Code Code Code Code

investigation:
Investigation
findings
(Annex C)

IMDRF Cause Code Code Code Code Code Code

investigation:
Investigation
conclusion (Annex D)

If exceptionally no relevant IMDRF code is available or specific enough, then provide additional information below

f IMDRF Component codes (Annex G)

Coding with IMDRF terms is a mandatory requirement.
Choice 1 Choice 2 Choice 3 Choice 4 Choice 5 Choice 6
(most relevant)
IMDRF 'Component' codes Code Code Code Code Code Code
(Annex G)

If exceptionally no relevant IMDRF code is available or specific enough, then provide additional information below

g Description of remedial action/corrective action/preventive action/field safety corrective action (FSCA)

(FSCA have to be reported separately)

h Time schedule for the implementation of the identified actions

i Final comments from the manufacturer on cause investigation and conclusion

4.3 Similar serious incidents (for Final serious incidents)
4.3.1 Use of IMDRF terms and codes for identifying similar serious incidents
a Identification of similar serious incidents using IMDRF Adverse Event Reporting terms and codes
Tick-mark which code or combination of codes were used for identifying similar serious incidents.
Choice 1
IMDRF code relating to most relevant 'Medical device problem' (Annex A)
IMDRF code relating to most relevant 'Investigation finding' (Annex C, ‘Cause investigation’)

Other – enter description of what similar (serious) incidents are based on and the rationale why the above IMDRF
codes were not used

4.3.2 Use of in-house terms/codes for identifying similar serious incidents

(until June 2025)

a If similar serious incident were not identified by IMDRF codes but by in-house codes, please provide the codes and terms below.

Choice 1

Code/term for most relevant medical device problem Code

Term
Code/term for most relevant root cause evaluation Code
Term

Other – enter description of what similar (serious) incidents are based on and the rationale why the above codes were not used

4.3.3 Number of similar serious incidents and devices on the market

a Indicate on which basis similar serious incidents were identified regarding the device or device variant:
Model Software Lot/Batch Product platform Other variant

Details of the selection made above

b Indicate on which criteria the number of devices on the market (also known as denominator data) is based on
(tick the most appropriate):
Devices placed on the market or put into service
Units distributed within each time period
Number of tests performed
Number of episodes of use (for reusable devices)
Active installed base
Units distributed from the date of declaration of conformity/CE mark approval to the end date of each time
period
Number of devices implanted
Other -describe
 c Enter the number of similar serious incidents (SI) and devices on the market for the indicated time periods
You must use yearly time periods unless:
A: a different time period has been specified by the European vigilance Working Group
B: the device has not been on the European market for more than three years

Time period (N) Time period (N-1) Time period (N-2) Time period (N-3)
Year to date = SI year calendar year one year calendar year two years calendar year three years
before SI year before SI year before SI year
in format YYYY-MM-DD in format YYYY-MM-DD in format YYYY-MM-DD in format YYYY-MM-DD

Start date
End date
Number of Number of Number of Number of Number of Number of Number of Number of
similar SI devices on similar SI devices on similar SI devices on similar SI devices on
market market market market
Country of
serious incident

EEA + TR + XI

World

d Comments on how similar (serious) incidents and associated number of devices on the market were determined

Section 5: General comments

 Coded summary of report (will be auto populated from previous selections)
Medical device name

Basic UDI-DI Unknown

UDI device UDI production

Unknown Unknown
identifier identifier

IMDRF adverse event reporting terms and codes

IMDRF=International Medical Device Regulators Forum. Coding with IMDRF terms is a mandatory requirement.
IMDRF clinical signs,
symptoms, conditions codes

IMDRF health impact codes

IMDRF Medical device

problem codes

IMDRF Component codes

IMDRF Cause investigation:

Type of investigation
IMDRF Cause investigation:
Investigation findings.
IMDRF Cause investigation:
Investigation conclusion.

Submission of this report does not represent a conclusion by the manufacturer and / or authorised
representative or the national competent authority that the content of this report is complete or
accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s)
caused or contributed to the alleged death or deterioration in the state of the health of any person.
I affirm that the information given above is correct to the best of my knowledge.
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Date
2000/01/01 01:00

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