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

 

1. Administrative information

1.1 Corresponding competent authority

1.2 Date, type, and classification of incident report






1.3. Submitter’s information

1.3.3 Submitter information




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

d) If this incident is covered under an FSCA, please provide the relevant numbers

1.3.2. Manufacturer information
1.3.3. Authorised Representative information
1.3.4. Submitter’s details if not also manufacturer or authorised representative
2. Medical device information

2.1 Unique Device Identification (UDI)

2.2 Categorisation of device

2.3 Description of device and commercial information

k) Date when device was implanted

to

l) Date when device was explanted

to

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

p)

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

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

1
2





2.4 Risk class of device when placed on market

a)


b)

MDD/AIMDD










IVDD




 

c)

MDR




Type (Multiple choice)

 

c)

IVDR




Type (Multiple choice)



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

a) Within EEA, Switzerland and Turkey

2.6 Use of accessories, associated devices or other devices

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

3.1 Nature of incident

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'


















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)

b) Age of patient at the time of the incident





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





4. Manufacturer analysis

4.1 Manufacturer’s preliminary comments

4.2 Cause investigation and conclusion







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)
IMDRF Cause investigation: Investigation findings (Annex C)
IMDRF Cause investigation: Investigation conclusion (Annex D)

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)
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.







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 for most relevant root cause evaluation


4.3.3 Number of similar incidents and devices on the market









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
5. Comments