Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD)

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1. Administrative information

1.1 Corresponding competent authority

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

a) Date of submission

b) Date of incident from

Date of incident to

c) Manufacturer awareness date

d) Type of reportInitial

e) In case of initial and follow-up reports, please indicate the expected date of the next report

f) Classification of incidentSerious public health threat
Death
Unanticipated serious deterioration in state of health
All other reportable incidents

1.3. Submitter’s information

1.3.3 Submitter information

a) Submitter of the reportManufacturer
Authorised Representative within EEA, Switzerland and Turkey
Others

Identify the role:

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 an FSCA, please provide the relevant numbers

NCA's local reference number

EUDAMED referenční číslo

Manufacturer's reference number

e) Periodic Summary Report (PSR) ID

f) If the incident occurred within a PMCF/PMPF investigation; please provide the Eudamed ID of that PMCF/PMPF investigation

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

2. Medical device information

2.1 Unique Device Identification (UDI)

a) UDI device identifier/Eudamed ID

b) UDI production identifier

c) Basic UDI-DI/Eudamed-DI

d) Unit of use UDI-DI

2.2 Categorisation of device

b) Medical device nomenclature code

2.3 Description of device and commercial information

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

b) Nomenclature text/Description of the device and its intended use

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

k) Date when device was implanted

l) Date when device was explanted

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

Notified body (NB) ID number(s) (if applicable)

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

q) Please indicate the date of one of the following:First declaration of conformity
The device first CE marked
First placed on the market
First put into service
If software, date first made available

Year

Month

2.4 Risk class of device when placed on market

2.5 Market distribution of device (region/country) (according to the best knowledge of the manufacturer)

Others:

2.6 Use of accessories, associated devices or other devices

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

b) Relevant associated devices used with the device being reported on (please list with corresponding Manufacturer if different from device being reported on)

3. Incident information derived from healthcare professional/facility/patient/lay user/other

3.1 Nature of incident

a) Uveďte komplexní popis příhody včetně 1) jak prostředek selhal (pokud je to možné) a 2) popis eventuálního vlivu na zdraví, např. klinické příznaky, symptomy, podmínky a celkový dopad na zdraví ( např. úmrtí, ohrožení života, hospitalizace - počáteční nebo prodloužená, doporučený zásah k eliminaci permanentního poškození, postižení nebo trvalé poškození, vrozená anomálie/defekt při porodu, nepřímé ohrožení, bez závažných následků)

3.2 Medical device problem information

a) IMDRF Medical device problem codes (Annex A)

Coding with IMDRF terms is a mandatory requirement.

	Choice 1 (most relevant)	Choice 2	Choice 3	Choice 4	Choice 5	Choice 6
IMDRF 'Medical device problem codes'

If you think the incident is unique and a suitable IMDRF term is missing, briefly explain:

b) Number of patients involved

Indicate

d) Operator of device at the time of the incidentHealth care professional
Patient/user
Other

Please describe

e) Usage of device (as intended)Initial use
Reuse of a single use medical device
Problem noted prior use
Reuse of a reusable medical device
Re-serviced/refurbished/fully refurbished
Other

Please describe

f) Remedial actions taken by healthcare facility, patient or user subsequent to the incident

3.3 Patient information

a) IMDRF 'Health Effect' terms and codes (Annex E, F). Coding with IMDRF terms is a mandatory requirement.

	Choice 1 (most relevant)	Choice 2	Choice 3	Choice 4	Choice 5	Choice 6
IMDRF 'Clinical signs, symptoms, and conditions codes' (Annex E)
IMDRF 'Health impact' codes (Annex F)

If you think the incident is unique and a suitable IMDRF term is missing, briefly explain:

b) Age of patient at the time of the incident

Number of years

Number of months

Number of days

c) GenderMale
Female
Unknown
Not applicable

d) Body weight (kg)

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

3.4 Initial reporter (can be healthcare professional of facility, patient, lay user)

a) Role of initial reporterHealth care professional
Patient

Other

Indicate

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

i) Street

j) Street number

k) Address complement

l) PO Box

m) City name

n) Postal code

4. Manufacturer analysis

4.1 Manufacturer’s preliminary comments

a) For initial and follow-up reports: preliminary results and conclusions of manufacturer’s investigation

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

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

4.2 Cause investigation and conclusion

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

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

c) Is root cause confirmed?Yes
No

d) Has the risk assessment been reviewed?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:

e) IMDRF ‘Cause Investigation' terms and codes (Annex B, C, D)

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

If you think the incident is unique and a suitable IMDRF term is missing, briefly explain:

f) IMDRF Component codes (Annex G)

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

If you think the incident is unique and a suitable IMDRF term is missing, briefly explain:

g) Description of remedial action/corrective action/preventive action/field safety corrective action (FSCA) (For a FSCA, fill in the FSCA form )

h) Time schedule for the implementation of the identified actions

i) Final comments from the manufacturer on cause investigation and conclusion

4.3. Similar incidents (for Final (Reportable incident))

4.3.1. Use of IMDRF terms and codes for identifying similar incidents

a) Identification of similar incidents using IMDRF Adverse Event Reporting terms and codes Tick-mark which code or combination of codes were used for identifying similar incidents.

IMDRF code relating to most relevant 'Medical device problem' (Annex A)Yes
No

IMDRF code relating to most relevant 'Investigation finding' (Annex C, ‘Cause investigation’)Yes
No

Other – enter description of what similar incidents are based on and the rationale why the above IMDRF codes were not usedYes
No

4.3.2 Use of in-house terms/codes for identifying similar incidents (only for transition period)

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

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 incidents are based on and the rationale why the above IMDRF codes were not usedYes
No

4.3.3 Number of similar incidents and devices on the market

a) Indicate to what criteria the number of devices on the market (also known as denominator data) is based on (tick the most appropriate):ModelSoftwareLot/BatchProduct platformOther variant

Details of the selection made above

b) Indicate to what 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 incidents and devices on the market for the indicated time periodss

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) Year to date = incident year		Time period (N-1) calendar year one year before incident		Time period (N-2) calendar year two years before incident		Time period (N-3) calendar year three years before incident
Start date
End date
	Number of similar incidents	Number of devices on market	Number of similar incidents	Number of devices on market	Number of similar incidents	Number of devices on market	Number of similar incidents	Number of devices on market
Country of incident
EEA + CH + TR
World

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

5. Comments

Comments