1
ENQUIRY TO
MEDICAL DEVICE COMPETENT AUTHORITIES
Helsinki procedure 2021
Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
Confidential between Member States
Problem: Qualification and classification of safety bands
Originating CA: Polish CA – The Office for Registration of Medicinal Products, Medical
Devices and Biocidal Products.
Contact Point: Aleksandra Rodatus
E-mail: incydenty@urpl.gov.pl
Circulated: 03-10-2025 Deadline: 24-10-2025
Extended deadline:
FROM
Responding CA:
Contact person:
E-mail: Fax:
Description of the case
The Polish Competent Authority (CA) has received multiple enquiries regarding the qualification and
classification of safety bands as medical devices (primarily intended for seniors).
1. The main function of some of these bands is to activate an SOS button and establish a connection
with a medical telecentre. The SOS button may be activated directly by the user, or the connection with
the telecentre may be triggered automatically as a result of fall detection. According to ICD-11 for
Mortality and Morbidity Statistics, a fall is classified as a death cause under code MB47.C Tendency to
fall, clarified as: “Tendency to fall because of old age or other unclear health problems”1.
Therefore, a band equipped with a fall detection function may be considered to contribute to the
diagnosis of this condition.
2. In addition, these bands often include further functionalities such as heart rate and oxygen saturation
monitoring. These measurements may either be read directly by the user or transmitted to a medical
telecentre or a caregiver.
According to Rule 10 of Annex VIII of Regulation (EU) 2017/745, active devices intended to allow direct
diagnosis or monitoring of vital physiological processes, unless they are specifically intended for
monitoring of vital physiological parameters and the nature of variations of those parameters is such
that it could result in immediate danger to the patient, for instance variations in cardiac performance,
respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations
where the patient is in immediate danger, in which cases they are classified as class IIb.. However,
according to MDCG 2021-24 Guidance on classification of medical devices (page 43), medical devices
1 https://icd.who.int/browse/2025-01/mms/en#1093196899
mailto:incydenty@urpl.gov.pl
2
intended to be used to obtain readings of vital physiological signals as part of routine checkups or self-
monitoring are in class IIa.
In the opinion of the Polish CA, safety bands that detect falls and automatically establish contact
with a telemedical centre should be regarded as medical devices. The rationale is that fall
detection combined with rapid medical intervention can allow the identification of a number of
conditions and diseases for which an uncontrolled fall may be a symptom. A useful comparison
can be made with infant apnea monitors, which are widely recognised as medical devices: by
detecting abnormal breathing patterns and triggering an alert, such devices contribute directly to
diagnosing serious conditions. In a similar way, safety bands that detect falls not only serve an alarm
function but also support medical assessment and diagnosis by signalling a potentially pathological
event.
It should be indicated that infant apnea monitors are intended to be used by all infants in general –
including those which are not prone to this condition. The same approach should be applied to safety
bands detecting fall, without previous information of such incidents of the bearer.
In this context, Polish CA would like to gather the views of other CA’s regarding the qualification and
classification of safety bands, which solely enable fall detection and communication with a medical
telecentre, as well as those that also include additional functionalities such as pulse and oxygen
saturation measurement, where the results may be transmitted via an application to a caregiver and/or
to a medical telecentre.
Enquiry result
Outcome of the enquiry
7 Member States responded to this enquiry. There is no majority view on the qualification and
classification of the safety bands intended to detect falls and report them automatically to a medical
telecentre.
The majority (100%) agreed, the safety band designed to detect falls and connected directly to a
medical telecentre with additional functions such as heart rate and oxygen saturation measurement is a
medical device. What is more, the majority (87.5%) agreed that safety band should it be classified as
Class IIa in accordance with Rule 10 when the measurements are visible only to the user and the
user's caregiver. However, there is no majority view on safety band classification when safety band
measurements are transmitted to a medical telecentre. 4 member states (50%) consider that safety
band should be classified as Class IIb in accordance with Rule 10 when the measurements are
transmitted to a medical telecentre, 2 member state consider that it sill should be classified as Class
IIa, and 1 member state consider, that safety band should be classified in its own right – Class I rule 1.
What is more there is no majority view on consideration that safety band which is intended to only
detect falls and report it automatically to a medical telecentre is a medical device its self.
Therefore, in accordance with point 22 of the Helsinki Procedure Polish CA invites the CAs to comment
on the summary and submit any additional information that may help for a period of 2 months
(deadline: 07/06/2026).
3
Question Answer Question Answer
Does safety band, intended to detect falls and
report them automatically to a medical
telecentre, meet a definition of medical device?
4/8 (50%) CAs consider that safety band
intended to detect falls and report them
automatically to a medical telecentre do not
meet a definition of medical device.
4/8 (50%) CAs consider that safety band
intended to detect falls and report them
automatically to a medical telecentre meet a
definition of medical device.
There is no majority view on the qualification of
the safety bands intended to detect falls and
report them automatically to a medical
telecentre.
If yes, what classification rule shall apply?
4/8 (50%) CAs consider that this question does
not apply.
2/8 (25%) CA consider that it depends. Rules 13
and 11 should be considered.
1/8 (12.5%) CA consider that rule 13 should be
apply.
1/8 (12.5%) CA consider that rule 10 should be
apply.
There is no majority view on the classification of
the safety bands.
Is a safety band designed to detect falls and
connected directly to a medical telecentre with
additional functions such as heart rate and
oxygen saturation measurement a medical
device?
8/8 (100%) CAs consider that safety band
designed to detect falls and connected directly to
a medical telecentre with additional functions
such as heart rate and oxygen saturation
measurement is a medical device.
There is a majority view (100%) on consideration
that a safety band designed to detect falls and
connected directly to a medical telecentre with
additional functions such as heart rate and
oxygen saturation measurement is a medical
device.
If yes, should it be classified as Class IIa in
accordance with Rule 10 when the
measurements are visible only to the user and
the user's caregiver?
6/8 (75%) CAs consider that safety band should
be classified as Class IIa in accordance with
Rule 10 when the measurements are visible only
to the user and the user's caregiver.
1/8 (12.5%) CA consider that it depends, but
safety band might be classified as Class IIa in
accordance with Rule 10 if it is for the purpose of
self-tracking.
1/8 (12.5%) CA consider that safety band should
not be classified as Class IIa in accordance with
Rule 10 when the measurements are visible only
4
to the user and the user's caregiver.
There is a majority view (87.5%) on
consideration that a safety band should it be
classified as Class IIa in accordance with Rule
10 when the measurements are visible only to
the user and the user's caregiver.
Or should it be classified as Class IIb in
accordance with Rule 10 when the
measurements are transmitted to a medical
telecentre?
4/8 (50%) CAs consider that safety band should
be classified as Class IIb in accordance with
Rule 10 when the measurements are transmitted
to a medical telecentre.
2/8 (25%) CAs consider that safety band should
not be classified as Class IIb in accordance with
Rule 10 when the measurements are transmitted
to a medical telecentre.
1/8 (12.5%) CA consider that it depends, safety
band may be classified as Class IIb or Class IIa
device depending on whether it is a routine
checkup or not.
1/8 (12.5%) CA consider that the band should be
classified in its own right. Class I rule 1.
There is no majority view on the classification of
the safety band designed to detect falls and
connected directly to a medical telecentre with
additional functions such as heart rate and
oxygen saturation measurement when the
measurements are transmitted to a medical
telecentre.
Additional rationale and remarks
2: Legal disclaimer: In Germany, BfArM makes binding decisions on the regulatory status, of a
medical device or an accessory for a medical device and/or classification of individual products at
the request of German manufacturers of medical devices, their authorised representatives, their
local Federal State Authorities ("Landesbehörde") or Notified Bodies.
The responsibility for surveillance of manufacture, placing on the market and circulation of medical
devices (including operation and use) lies not with the BfArM (responsibility of the Federal State
Authorities according to § 85 Medizinprodukterecht-Durchführungsgesetz - MPDG).
5
CA Q1
Does safety band,
intended to detect falls
and report them
automatically to a medical
telecentre, meet a
definition of medical
device?
Q2
If yes, what
classification rule
shall apply?
Q3
Is a safety band designed
to detect falls and
connected directly to a
medical telecentre with
additional functions such
as heart rate and oxygen
saturation measurement a
medical device?
Q4
If yes, should it be
classified as Class IIa in
accordance with Rule 10
when the measurements
are visible only to the user
and the user's caregiver?
Q5
Or should it be classified as
Class IIb in accordance with
Rule 10 when the
measurements are
transmitted to a medical
telecentre?
1 NO
If the band is intended
solely to detect a fall, of a
senior, it wouldn’t comply
with the legal definition of
a medical device.
N/A YES
The additional monitoring
functions of vital
physiological processes,
aiding in a diagnosis
process, brings it into the
remit of the legal definition
of a medical device.
YES
-
Still class IIa
The band obtains readings of
vital physiological signals as
part of self-monitoring and in
the circumstance of a fall
transmits to the medica
telecenter to further inform
them on the person’s state
post fall.
2 YES Depends
The rule to be
applied depends
on the intended
purpose. If the
main function is
performed by a
software, rule 11
should also be
taken into account
here.
YES Depends
The device is intended to
monitor vital physiological
parameters. For the
purpose of self-tracking,
we agree with a class IIa
classification. If the
parameters are
transmitted to a caregiver
in real-time, we would opt
for a IIb classification.
YES
Transmitting vital parameters
in real-time for monitoring
purposes and potential
urgent intervention fulfil the
criteria for a class IIb
classification.
3 NO N/A YES YES YES
6
The detection of falls and
their communication to an
telecentre is not a medical
purpose as defined in
Article 2 of Regulation
(EU) 2017/745. It is not
intended for a diagnosis or
therapeutic purpose but
just a communication
regarding the behavior of
an elderly person (falls
detection, with alerts sent
to a telecentre if
necessary).
The functionality such as
heart rate and oxygen
saturation measurement
must be specifically CE
marked as medical device
because this purpose of
monitoring vital
parameters is a medical
purpose according to
article 2 of MDR.
Devices intended for
monitoring vital
physiological processes
and parameters as heart
rate and oxygen saturation
include self-monitoring
devices. According rule
10, they are in class IIa, as
precised by guidance
MDCG 2021-24 on
classification of MD.
According to rule 10 of Annex
VIII to Regulation (EU)
2017/745, active devices
intended for monitoring vital
physiological parameters, the
nature of which is such that
variations in these
parameters could lead to an
immediate danger to the
patient, for example
variations in cardiac
performance, and which are
intended for diagnosis in
clinical situations where the
patient is in immediate
danger, are classified in class
IIb. The heart rate and
oxygen saturation
measurements are
transmitted in the event that
the patient falls and is in
distress, which implies a life-
threatening emergency.
Therefore, in this case, this
functionality should be
classified as IIb.
4 NO
The panic button is not a
medical device but a
personal alarm system.
The band or strap is an
accessory of the panic
button, since the button is
not a md, the accessory is
neither.
NA YES
Then it is an accessory to
a medical device.
NO
Not the band, that is to be
classified in its own right.
Class I rule 1.
NO
Not the band, that is to be
classified in its own right.
Class I rule 1.
7
5 YES
Contributes to detecting
states of health
(diagnosis) by supplying
information.
Rule 10 YES
Please, see above.
Additionally, vital
physiological process
monitoring constitutes a
medical intended purpose.
YES
Class IIa if only routine
checkups or self-
monitoring of vital
physiological processes is
included.
YES
Class IIb if the device is used
in continuous surveillance
and produces alarms if any of
the physiological parameters
monitored vary beyond pre-
set limits and the variation
could result in immediate
danger to the patient.
6 YES
The detection of falls is not
necessarily a medical
purpose. However, when
this detection is integrated
into a system that alerts a
medical telecentre,
potentially leading to
medical intervention, it
transitions into a medical
purpose. This is
particularly significant
when such systems are
utilized by vulnerable
populations, including the
elderly or individuals with
disabilities.
Rule 13,
potentially 11.
Class I
Rule 13, class I
applies.
Even though the
product is used for
monitoring, it does
not monitor
physiological
processes. The
device only alert
that position in
space has
changed.
Rule 11 may apply
since it might
involve a medical
software. Even
though the safety
band alerts a
medical telecentre,
the output is not
used to take
decisions with
YES
Monitoring of physiological
processes, such as heart
rate and oxygen
saturation, is a medical
device when the purpose
is to monitor a disease,
injury, or disability.
The safety bands in
question appear to fulfill
this definition, as they are
designed to detect
abnormal physiological
readings and automatically
initiate contact with a
telemedical center during
situations when deviations
trigger alerts. This
functionality suggests that
the safety bands serve a
medical purpose, given
their role in monitoring
physiological parameters
and responding to
potential health concerns.
Consequently, such safety
YES
According to the
guidelines outlined in
MDCG 2021-24,
specifically Note 3 and
Rule 10, medical devices
designed to provide
readings of vital
physiological signals for
routine checkups or self-
monitoring are classified
as Class IIa. Since the
device in question displays
heart rate and oxygen
saturation, which are
considered vital
parameters, and its visible
output is utilized for
obtaining these readings
as part of routine
checkups or self-
monitoring, it falls under
the classification of Class
IIa as per Rule 10.
Depends
If the aim of the
measurements transmitted to
a medical telecentre is to
alarm the centre and trigger a
routine checkup, it would not
be classified as Class IIb.
This is because routine
checkups are generally
considered non-urgent and
do not require immediate
medical intervention.
However, if the
measurements transmitted to
a medical telecentre are used
to trigger emergency care,
then they would be classified
as Class IIb. Emergency care
situations involve immediate
risk to the patient's health,
and the information
transmitted is critical for
making urgent medical
decisions. In such cases, the
classification as Class IIb is
appropriate due to the high
8
diagnosis or
therapeutic
purposes. The
safety band only
provide information
that a potential
medical
intervention may
be required, but not
which medical
intervention.
Therefore, if the
safety band
includes is a
MDSW, class I also
applies (all other
software)
bands qualify as medical
devices.
risk and the need for
immediate action.
7 NO
When the intention is to
detect a fall then the
safety bands do not fall
the definition of a medical
device.
N/A YES
Additional functionalities to
monitor vital physiological
process – it is a medical
purpose.
YES
According to MDCG 201-
24 - medical devices
intended to be used to
obtain readings of vital
physiological signals as
part of routine checkups or
self-monitoring are in class
IIa
YES
Class IIb, rule 10, when it is
specifically intended for
monitoring of vital
physiological parameters and
the nature of variations of
those parameters is such that
it could result in immediate
danger to the patient.
8 YES
A safety band that detects
a fall and automatically
contacts a medical call
centre may be classified
as a medical device, as its
intended purpose is to
ensure a rapid response in
the event of a potential
Rule 13 class I
This safety band
does not monitor
vital physiological
parameters; it
detects falls and
therefore signals a
change in the
YES
A safety band that, in
addition to detecting falls,
also monitors
physiological parameters
such as heart rate and
oxygen saturation, may be
classified as a medical
device, as the
YES
In accordance with the
guidelines set out in
MDCG 2021-24,
specifically Note 3 and
Rule 10, medical devices
intended for the
measurement of
physiological parameters
NO
Measurements of
physiological parameters,
such as heart rate and
oxygen saturation, are
displayed on the safety
wristband or in the
associated app as part of
routine monitoring of the
9
injury among people in
high-risk groups (e.g. the
elderly), which falls within
the definition of a medical
device, covering, amongst
other things, the alleviation
of injuries. The detection
of a fall itself – although it
does not constitute the
monitoring of vital
physiological parameters –
is a significant clinical
event, as it enables an
immediate assessment of
the user’s condition and
the initiation of medical
measures that may limit
the development of
complications associated
with being left without
assistance. Consequently,
the band supports the
user’s health and safety in
the event of an emergency
and contributes to the
faster provision of
appropriate care, which
justifies its classification as
a medical device given its
intended use.
user’s position. measurement and
monitoring of physiological
processes are directly
intended for medical
purposes. Even if contact
with a medical call centre
is initiated only in the
event of a fall being
detected, the data
collected by the device
regarding heart rate and
blood oxygen saturation
has potential clinical value:
they can provide the user
and medical staff with
relevant information about
changes in health status,
worrying trends or
deviations from the norm
that may require further
assessment or
intervention.
Consequently, such a
device, due to its function
of monitoring physiological
processes and supporting
the assessment of the
patient’s condition, meets
the definition of a medical
device.
as part of routine
monitoring or self-
monitoring are classified
as Class IIa devices. As
the device displays heart
rate and oxygen
saturation, which are
considered vital
parameters, and its visible
output is used to obtain
these readings as part of
routine monitoring or self-
monitoring, it is classified
as a Class IIa device in
accordance with Principle
10.
user’s condition and are
accessible to both the user
and their carer. However, the
primary purpose of the device
remains the detection of a fall
and the transmission of
information about this event
to a medical call centre.
Physiological data do not
trigger automatic, immediate
medical intervention, but
merely provide the user and
carer with additional
information about the user’s
health. The physiological
monitoring function classifies
the device as a medical
device; however, the lack of
direct use of this data for
immediate intervention
means that the device falls
within Class IIa, as a device
monitoring parameters of
clinical significance, but is not
intended for the immediate
initiation of medical action
based on the measurements
taken by the band.
On behalf of the President
Aleksandra Rodatus
2026-04-08T07:25:03+0000
Aleksandra Rodatus
16.04.2026
Datei
PD
1
Manufacturer incident report (MIR) v7.3.1 Helptext
for reporting Serious Incidents (MDR/IVDR)
1. MIR Helptext
2. Rules
3. EMDN Coding & IMDRF Adverse Event Terminology
4. Medical Device Risk Class and Notified body properties
5. XML Element Field Map
6. List of extra fields (displayed at the end of the MIR)
7. Guidance for splitting the MIR PDF with Adobe Acrobat
Please note:
It is important to strictly follow the numbering of the document (top-down) when filling up sections in
the MIR form.
Free text fields are limited to 4000 characters (approximately 1 A4).
Adobe Acrobat Professional is necessary for saving, signing and XML data import/export.
Jean-Francois ROCHE
Highlight
2
MIR Helptext
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
1. Administrative information
1.1 Responsible competent authority in which country the incident occurred
a Name of receiving national
competent authority (NCA)
NCA to which the report is being sent.
Y Y Y Y Y
List is available here:
https://health.ec.europa.eu/medical-devices-sector/new-regulations/contacts_en
under Vigilance contact points.
b EUDAMED Number of NCA Unique EUDAMED number of NCA (could be auto filled/selected once EUDAMED
available). N N N N N Will be mandatory as soon as available in EUDAMED.
c Reference number assigned by NCA
for this incident
The reference number of the NCA for this incident. This is a mandatory field when
reference number is provided by the NCA.
If no reference number is provided by the NCA, please add 'Unknown' in the
follow-up and final reports.
N N Y Y Y
d Reference number assigned by
EUDAMED for this incident
The reference number assigned by EUDAMED for this incident (after
upload/entering incident into EUDAMED). N N N N N Will be mandatory as soon as available in EUDAMED.
1.2 Date, type, and classification of incident report
a Date of report submission Date when you submit the report - The predefined date format is:
YYYY-MM-DD. Y Y Y Y Y
b Date of incident Date when incident happened.
- if incident date is unknown, please enter a date range when you think
the incident occurred.
- If this incident is a result of a literature report, please enter a date range
similar to the range of the report.
Y Y Y Y Y
Please note:
- In case the specific date is known you only have to enter it once into the first
field. The same date is automatically entered into the second field.
- In case of a timespan, you need to adjust the second field accordingly.
c Manufacturer awareness date of the
incident
The ‘manufacturer awareness date’ is the date, when the first employee or
representative of the manufacturer’s organisation receives information (e.g., a
complaint) regarding the incident.
Y Y Y Y Y
Please note:
- Please refer to the guidance document MDCG 2023-3: Questions and Answers on
vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on
medical devices for further information on what is considered as the
‘manufacturer awareness date’.
d Manufacturer awareness date of
reportability
In this field, the manufacturer should insert the date in which it received the
information that determined that the incident is reportable and thus met the
criteria of a incident. Y Y Y Y N
Please note:
- Please refer to the guidance document MDCG 2023-3: Questions and Answers on
vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on
medical devices for further information on what is considered as the
‘manufacturer awareness date of reportability’.
e Type of Report Initial Report - Choose this for your first report on a particular incident if your
investigation is not complete and a combined report cannot be submitted. It may
be initiated under the Vigilance system or may stem from a User incident Report
notified to you by the relevant CA.
Follow-up report - Choose this to provide additional/interim information during
your investigation. You can submit more than one follow-up report for each
incident. Note this option is only available once you have submitted an initial
Y Y Y Y Y
Please note:
- A report submitted as type “Final (reportable incident)” fulfils the definition of a
‘serious incident’ according to article 2 MDR/IVDR and the reporting criteria for a
serious incident as defined in article 87(1) MDR, article 82(1) IVDR”.
- MDR art. 87(3), IVDR art. 82 (3); Manufacturers shall report any serious incident
immediately after they have established the causal relationship between that
serious incident and their device or that such causal relationship is reasonably
https://health.ec.europa.eu/medical-devices-sector/new-regulations/contacts_en
3
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
report.
Combined initial & final - Choose this if you have the details of the initial and final
report within the initial timeframe for reporting. Note that this option is not
available once you have submitted an initial report.
Final (Reportable incident)- This is your formal statement of the outcome of your
investigation, including any actions proposed or taken. It is recognized that a
further ‘Final’ report may be necessary in circumstances where additional
information only becomes available at a later stage. Please indicate which
information has changed in case an updated final report is submitted. Note this
option is only available once you have submitted an initial report.
Final (Non-reportable incident)- This is to be used for cases where the
manufacturer has submitted a MIR to the relevant competent authority but
establishes through its investigation that the criteria for a serious incident were
not met OR for cases where the manufacturer has received a report of a
potentially serious incident from the competent authorities (Article 87(11)
MDR/Article 82(11) IVDR) but establishes within the specified timelines that the
requirements for a serious incident are not fulfilled. For further information,
please refer to the MDCG 2023-3 Rev. 2 (Q16). By selecting this option, the only
mandatory field in section 4 is 4.2b..
It is possible to send an update at any stage to each type of reports except for the
initial report e.g. update to the final report.
possible and not later than 15 days after they become aware of the serious
incident.
- Reporting timelines: For details on the interpretation of the reporting timelines
for the different classes of incidents, please refer to the guidance document:
MDCG 2023-3: Questions and Answers on vigilance terms and concepts as
outlined in the Regulation (EU) 2017/745 on medical devices.
f In case of initial and follow-up
reports, please indicate the expected
date of next report
The date by which you expect to be able to submit your next report on this event.
This may be either a Follow-Up or Final report. N Y Y N N
g Classification of serious incident Please classify the serious incident according with the following definitions:
Serious public health threat:
An incident which could result in imminent risk of death, serious deterioration in a
person's state of health, or serious illness, that may require prompt remedial
action, and that may cause significant morbidity or mortality in humans, or that is
unusual or unexpected for the given place and time.
Death:
A incident of death must be reported as soon as a causal relationship has been
established with the device but not later than 10 days from the awareness date.
An incident of Death cannot be exempted from reporting when expected side
effects have also been reported and it is reasonable possible that these expected
side effects contributed to the patient outcome of death.
An unanticipated serious deterioration in state of health: A deterioration in state
of health is considered UNANTICIPATED if the condition leading to the event was
not considered in a risk analysis.
NOTE: Documented evidence in the design file is needed that such analysis was
used to reduce the risk to an acceptable level, or that this risk is well known by the
intended USER.
All other reportable incidents:
These are incidents which did not involve a death (where a causal relationship has
been determined) and which were not unanticipated but:
Y Y Y Y N
Please note:
- A report submitted as “All other reportable incidents:” fulfils the definition of a
‘serious incident’ according to article 2 MDR/IVDR and the reporting criteria for a
serious incident as defined in article 87(1) MDR, article 82(1) IVDR”.
- Reporting timelines: For details on the interpretation of the reporting timelines
for the different classes of incidents, please refer to the guidance document:
MDCG 2023-3: Questions and Answers on vigilance terms and concepts as
outlined in the Regulation (EU) 2017/745 on medical devices.
4
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
1. led, might have led, or might lead to a serious deterioration in the state
of health of a patient, user or other person.
2. and the event is linked or might have been linked to device malfunction,
deterioration in the characteristics or performance of the device or an
inadequacy in the information supplied by the manufacturer.
1.3 Submitter information
1.3.1 Submitter of the report
a Submitter of report Who is submitting the report.
Y Y Y Y Y
Please note:
- Adobe Acrobat Professional is necessary for signing and XML data import/export.
- Depending on the type of submitter selected fields in section 1.3.2 (MFR), 1.3.3
(AR) or 1.3.4 (submitter) become mandatory.
- It is important to strictly follow the lines order (top-down) when filling-up
sections in the MIR form.
b Manufacturer's reference number
for this incident
The reference number assigned by the manufacturer. The Manufacturer's
reference number must be unique. Y Y Y Y Y
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
If other devices were involved in the incident, you must send a separate MIR form
for each device. List the reference numbers of the NCA, EUDAMED and
manufacturer here (As each suspected device will have its own report as opposed
to section 2.6 where only accessories associated to the suspected device(s) are
listed).
Please use a semi colon to separate multiple values
1.3.c, 2.6: If you are certain of the device that caused the incident, then this device
is what should be reported on the form.
List any associated accessories in:
- 2.6a, which could be from a different manufacturer if known.
- 2.6b, for any other devices (which could also be from a different
manufacturer if known).
This will indicate to the CA that those other manufacturers should also submit a
MIR.
N N N N N
Please note:
- 1 MIR is linked to 1 device.
- Separate MIRs should be submitted by the manufacturer when several devices
and their accessories are involved in a incident (one for each device).
- If the manufacturer is confident that some devices present cannot be the cause
of the incident, it will not be required to submit a separate MIR for each device,
but will specify them in section 2.6 b. However, if the NCA has doubts about the
conclusion made by the manufacturer, submitting an additional MIR for other
devices specified in section 2.6. might be required.
- Accessories and systems/procedure packs in the context of future EUDAMED. It is
not possible to submit a MIR for an accessory or a systems/procedure pack that is
not a device in its own right, only a manufacturer of a device or its authorised
representative if applicable (and their sub-contractors acting on their behalf) may
submit a MIR, not a system/procedure pack producer.
d If this incident is covered under a
FSCA, please provide the relevant
numbers:
Please add the relevant FSCA number when evidence confirms that the incident
observed is associated with the FSCA (i.e., upon manufacturer investigation).
NCA's local FSCA reference: The NCA reference number assigned to the FSCA that
this incident covers.
EUDAMED's FSCA reference number: Future EUDAMED reference number
assigned to the FSCA that this incident covers.
If the FSCA sent to the NCA contained multiple issues, the NCA may assign a
unique number to each issue.
If this incident in this report is related to one of those issues, list the unique
number assigned by the NCA for that issue in the field "NCA's local FSCA
reference"
Please use a semi colon to separate multiple values.
N N N N N
5
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
e Periodic Summary Report (PSR) ID Please quote the unique PSR-ID (determined by the Manufacturer) for the
incident if it is reportable under PSR.
Please use a semi colon to separate multiple values. N N N N N
Please note:
- A new methodology for PSR submission is currently under development for
reporting of PSR in EUDAMED. This field is here as a placeholder to facilitate this
new method of submission.
f The incident occurred within a
PMCF/PMPF investigation
If the incident occurred within a PMCF/ PMPF investigation; please provide the
EUDAMED ID of that PMCF/PMPF investigation. N N N N N
Please note:
- The word 'studies' is generally used for PMCF/PMPF however the MDR refers to
this as 'investigation' and IVDR as ‘studies’.
1.3.2 Manufacturer information
a Manufacturer Organisation name The name of the Manufacturer for the device involved in this incident. Y Y Y Y Y
b Single registration number SRN is the unique identifier which will be the unique identifier of actors in the
future EUDAMED. When an SRN is available, an SRN field will be completed and
will pre-populate in EUDAMED the manufacturer details, including the
Manufacturer's name.
Y Y Y Y Y
Please note:
- The use of an SRN is not mandatory before EUDAMED becomes fully functional. If
the manufacturer has not obtained an SRN yet, “Unknown” can be filled in the
text field.
- SRN of Manufacturer is different from the AR SRN number.
- Need to obtain an SRN before submitted the MIR or uploading the XML file in
future EUDAMED.
c Contact's first name First name of the manufacturer contact person.
Y Y Y Y Y
Please note:
- Information in c, d, e and f will not be auto populated when EUDAMED becomes
mandatory. These fields will be editable so can be overwritten/updated.
d Contact's last name Last name of the manufacturer contact person.
Y Y Y Y Y
Information in c, d, e, f will not be auto populated when in EUDAMED. These fields will be
editable so can be overwritten/updated.
If there is an Authorised Representative, the AR will be the preliminary contact for CA when
manufacturer is outside Europe. Please also include a manufacturer contact (as well as the
Authorised Representative.)
e Email E-mail of the manufacturer contact person.
Y Y Y Y Y
Information in c, d, e, f will not be auto populated when in EUDAMED. These fields will be
editable so can be overwritten/updated.
If there is an Authorised Representative, the AR will be the preliminary contact for CA when
manufacturer is outside Europe. Please also include a manufacturer contact (as well as the
Authorised Representative.)
f Phone Telephone number of the manufacturer contact person.
Y Y Y Y Y
Information in c, d, e, f will not be auto populated when in EUDAMED. These fields will be
editable so can be overwritten/updated.
If there is an Authorised Representative, the AR will be the preliminary contact for CA when
manufacturer is outside Europe. Please also include a manufacturer contact (as well as the
Authorised Representative.)
g Country The country where the manufacturer is located.
Y Y Y Y Y
Please note:
- 2 options are available: to use the drop-down list or to write the 2 letters of the
country acronym.
h Street The street of the manufacturer. Y Y Y Y Y Street is a mandatory field, 1.3.2 i, j and k are complement.
i Street number The street number of the manufacturer. N N N N N
j Address complement The address where the Manufacturer is located. E.g., building name. N N N N N
k PO Box The P.O box of the manufacturer. N N N N N
6
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
l City name The name of the city where the manufacturer is located. Y Y Y Y Y
m Postal code The postal or zip code where the manufacturer is located. Y Y Y Y Y
1.3.3 Authorized representative information
a Authorised representative
organisation name
The name of the Authorised representative for the device involved in this adverse
incident. Y Y Y Y Y
Mandatory properties are applicable to section 1.3.3 if manufacturer is not located within
the EU /EEA/ Turkey or Northern Ireland.
b Single registration number SRN is the unique identifier which will be the unique identifier of actors in the
future EUDAMED. When an SRN is available, an SRN field will be completed and
will pre-populate in EUDAMED the Authorised representative details, including
the Authorised representative's name.
Y Y Y Y Y
Please note:
- The use of an SRN is not mandatory before EUDAMED becomes fully functional. If
the manufacturer has not obtained an SRN yet, “Unknown” can be filled in the
text field.
- SRN of Manufacturer is different from the AR SRN number.
- Need to obtain an SRN before submitting the MIR or uploading the XML file in
future EUDAMED.
c Contact's first name First name of the Authorised representative contact person. Y Y Y Y Y
d Contact's last name Last name of the Authorised representative contact person. Y Y Y Y Y
e Email E-mail of the Authorised representative contact person. Y Y Y Y Y
f Phone Telephone number of the Authorised representative contact person. Y Y Y Y Y
g Country The country where the Authorised representative is located.
Y Y Y Y Y
Please note:
- 2 options are available: to use the drop-down list or to write the 2 letters of the
country acronym.
h Street The street of the Authorised representative. Y Y Y Y Y Street is a mandatory field, 1.3.3 i, j and k are complement.
i Street number The street number of the Authorised representative. N N N N N
j Address complement The address where the Authorised representative is located. E.g., building name. N N N N N
k PO Box The P.O box of the Authorised representative. N N N N N
l City name The name of the city where the Authorised representative is located. Y Y Y Y Y
m Postal code The postal or zip code where the Authorised representative is located. Y Y Y Y Y
1.3.4 Submitter’s details if not also manufacturer or authorised representative
a Registered commercial name of
company
(Third party) entities appointed to perform Vigilance reporting on behalf of the
manufacturer or the Authorised Representative.
Y Y Y Y Y
Mandatory properties are applicable to section 1.3.4 if Submitter of report is 'Other'
b Contact's first name First name of the person to contact about the incident. Y Y Y Y Y
c Contact's last name Last name of the person to contact about the incident. Y Y Y Y Y
d Email The email address for the submitter. Y Y Y Y Y
e Phone The telephone number for the company. Y Y Y Y Y
f Country The country where the company is located.
Y Y Y Y Y
Please note:
- Do not write in this field, it does not autocomplete to full entry. Please use the
drop down list.
g Street The street of the submitter. Y Y Y Y Y Street is a mandatory field, 1.3.3 h, i and j are complement.
h Street number The street number of the submitter. N N N N N
i Address complement The address where the company is located- e.g. building name. N N N N N
j PO Box The P.O box of the submitter. N N N N N
k City name The name of the city where the company is located. Y Y Y Y Y
l Postal code The postal or zip code where the company is located. Y Y Y Y Y
7
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
2. Medical Device Information
2.1 Unique Device Identification (UDI)
a (Master) UDI-DI/Eudamed ID The Unique Device Identifier - Device Identifier (UDI-DI)
UDI-DI is a unique numeric or alphanumeric code specific to a device (an unique
identificator of the device itself). A unique (Primary) Identifier for a Device, Device
Model, Package Structure element or Unit of Use. It is the static data portion of
the UDI. e.g., a GS1 or GTIN.
Master UDI-DI is the unique identifier used for grouping of certain highly
individualised devices. Such highly individualised devices present specific
similarities with respect to defined clinically relevant parameters (e.g. a Master
UDI-DI should be assigned to contact lenses that have the same combination of
contact lens design parameters, including at least base curve and diameter).
Custom made devices
Custom-made medical devices and performance study/investigational devices do
not require a UDI.
Procedure packs
In cases where devices are supplied within a system or procedure pack, if an
individual device is being reported on, use the UDI-DI for the device and record
the system or procedure pack information in 2.6 as an associated device. If the
system or procedure pack is being reported on, then use the UDI information for
the system or procedure pack.
Legacy devices
In the event of a serious incident with a legacy device, it has to be registered in
EUDAMED unless ‘the same device’ is already registered as a Regulation device.
Exceptionally, it must also be registered in case the serious incident concerns the
legacy device and not ‘the same’ Regulation device. An EUDAMED ID will be
assigned to the device instead of the Basic UDI-DI. For the rules applicable to the
registration of legacy and Regulation devices in the UDI / DEV module of
EUDAMED, please refer to Questions 7, 8 & 14 of the Q&A document on gradual
roll-out of EUDAMED.
Old devices
Old devices cannot be registered in the UDI/DEV module and, thus, will not have
an UDI-DI in EUDAMED. In case an old device is the subject of a serious incident
report (MIR), the manufacturer will need to provide a limited device data set to
submit the relevant report in the vigilance (VGL) module (see also Question 8 of
the Q&A document on gradual roll-out of Eudamed).
Y N N Y Y
Procedure Packs and Systems
(MDR Article 2 (10), (11))
Legacy Devices
Devices, which can continue to be placed on the market under Directive certificates by
virtue of Article 120(3) of Regulation 745/2017 (MDR), and Article 110(3) of Regulation
746/2017 (IVDR) after the relevant regulation application dates.
OLD devices
“Old devices” are those medical devices that were placed on the market before 26 May
2021 in accordance with the AIMDD or the MDD or in accordance with the applicable rules
before the Directives have entered into force and those “in-vitro diagnostic medical
devices” that were placed on the market before 26 May 2022 in accordance with Directive
98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro
diagnostic medical devices or in accordance with the applicable rules before the Directive
had entered into force.
Same device:
Means that Regulation device and legacy device have the same identification; such as UDI-
DI., and/or catalogue/reference number and/or trade name which follows from shared
characteristics. For details on the definition of “same device” and the applicable rules for
registration, see Questions 8 of the Q&A gradual roll-out of EUDAMED.
Issuing Entity:
The Commission has designated one or several entities to operate a system for assignment
of UDI’s ('issuing entity'). Complete this filed by selecting from drop down the applicable
designated entity (e.g., GSI, HIBCC) that your organization used to assign device
information required for device registration in EUDAMED.
Please note:
- Issuing entity: The drop down list blank field option to be used for resetting the
issuing entity. N/A (non applicable) for devices no issuing entity is involved.
- This field is N/A for “old devices”.
- Please refer to the Delegated Regulation: Commission Delegated Regulation (EU)
2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European
Parliament and of the Council, as regards the assignment of Unique Device
Identifiers for contact lenses (europa.eu) for further information on Master UDI-
DI.
- For further information on device registration and vigilance reporting please refer
to the Q&A; Q&A on practical aspects related to the implementation of the
gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by
Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU)
2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in
case of interruption or discontinuation of supply, and transitional provisions for
certain in vitro diagnostic medical devices.
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197
https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf
https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf
https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf
https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf
https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf
https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf
8
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
b UDI production identifier The UDI-PI is a numeric or alphanumeric code that identifies the unit of device
production. The different types of UDI-PIs include serial number, lot number,
software identification and manufacturing or expiry date or both types of date.
The UDI Production Identifier (PI) - default value to be ‘Unknown’ and for
MDD/IVDD risk class devices this field is not mandatory but for MDR/IVDR risk
class devices this field is mandatory.
Legacy and old devices will not have an UDI PI. Please write unknown.
Custom made devices and investigational devices will not have a UDI-PI. Please
write unknown.
The UDI Production Identifier (PI) - if unknown at time of submission please leave
as 'unknown' and fill out on follow up or final if available.
If two devices, with the same UDI-PI have failed in the same way you must fill out
two MIR forms. Please do not add multiple UDI PIs to 1 MIR.
Y N N Y Y
Please note:
- UDI PI is only required for MDR/IVDR CE certified products.
c Basic UDI-DI/Eudamed DI The Basic UDI-DI is the main key in the database and relevant documentation
(e.g., certificates, declaration of conformity, technical documentation and
summary of safety and clinical performance) to connect devices with same
intended purpose, risk class and essential design and manufacturing
characteristics. It is independent/separate from the packaging/labelling of the
device and it does not appear on any trade item.
The Basic UDI-DI shall identify the devices covered by that Basic UDI-DI in a unique
manner.
Basic UDI-DI is only required for EU 2017/745 or EU 2017/746 Regulation-
compliant devices.
Legacy devices that will be registered in EUDAMED (for specific conditions see
comment section) without UDI, will need two other unique access keys (IDs) to
replace the Basic UDI-DI and UDI-DI for the sake of the workability of EUDAMED
(see also 2.1a). An EUDAMED DI will be assigned to the device instead of the Basic
UDI-DI.
Y N N Y Y
Please note:
- Issuing entity; detailed information under UDI-DI (section 2.1a). The drop down
list blank field option to be used for resetting the issuing entity. N/A (non
applicable) for devices no issuing entity is involved.
- This field is N/A for “old devices”.
- Legacy devices for which no individual (sales) units are placed on the market from
the date when the UDI/DEV module becomes mandatory, only need to be
registered in the UDI/DEV module when the legacy device is the subject of a
serious incident report (MIR) and the same device is not already registered as a
Regulation device.
- For the rules applicable to the registration of legacy and Regulation devices in the
UDI / DEV module of EUDAMED, please refer to Questions 7 and 8 of the Q&A
document on gradual roll-out of EUDAMED”.
- Same device:
Means that Regulation device and legacy device have the same identification;
such as UDI-DI., and/or catalogue/reference number and/or trade name which
follows from shared characteristics. For the definition of “same device”, see
Question 8 of the Q&A document on gradual roll-out of EUDAMED.
d Unit of use UDI-DI An identifier assigned to an individual medical device when a UDI-DI is not labelled
on the individual device at the level of its unit of use, for example in the event of
several units of the same device being packaged together.
N N N N N
9
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
2.2 Categorisation of device
a Medical device nomenclature Select the EMDN (or where needed the other nomenclature) code of your product
(see also chapter 3, link)
Field used to provide information on the medical device nomenclature used by
your organization. If the nomenclature system is unavailable in drop down menu,
please select other and input the system used to assign an international naming
and grouping convention to your medical device.
For Legacy devices select the code system that your organisation uses for legacy
devices (devices with valid Directive certificate placed on the market after date of
application of the Regulation).
N N N N N
Please note:
- EMDN is the preferred nomenclature. EMDN primarily serves regulatory purposes
to support MDR and IVDR requirements. It is intended to support all actors in
their activities under the MDR/IVDR and provides key device descriptions to
patients as regards their own devices and all other devices available on the
market and registered in EUDAMED.
- See also MDCG 2021-12; FAQ on the European Medical Device FAQ on the
European Medical Device Nomenclature (EMDN)
b Medical device nomenclature code Enter the numeric code provided by your organization nomenclature coding
system (See 2.2a) that describes the device. N N N N N
Please note:
- If a medical device nomenclature is selected (See 2.2a), providing the
corresponding medical device nomenclature code that describes the device and
the nomenclature text in field 2.3b becomes a mandatory requirement.
- For example; When selecting EMDN please enter the EMDN Code: L010102:
which is associated with the EMDN description “Scalpel blades, reusable”.
2.3 Description of device and commercial information
a Medical device name
(Brand/Trade/Proprietary or
Common name)
The Medical device name to which this report refers. The Medical device name is
defined as: A name used to assist in the identification of the regulated medical
device (source; IMDRF)
-For initial reporting, if unknown, put 'unknown' and update in a followup report
when you receive the information.”
Y Y Y Y Y
b Description of the device and its
intended purpose
Description of the device and its intended use: Please briefly describe the device
and its intended use of the device as outlined in the IFU.
Example 1: 'Hip Implant'
Example 2: 'Cardiac Marker'
Y N Y Y Y
Please note:
- The mandatory requirements apply only to the first free-text box of field 2.3.b.
(see below for the 2nd free text box of field 2.3.b.).
b Nomenclature text Please use primarily the EMDN nomenclature text associated with defining the
code used in 2.2b.
As already mentioned in right column for field 2.2.a. it is possible to use other
nomenclatures than EMDN: see draft change proposal in the last column
Y N Y Y Y
Please note:
- This field only appears when selecting a nomenclature type in section 2.2a.
- Mandatory requirement applies only when a medical device nomenclature type
has been selected in field 2.2.a.
c Model The medical device model to which this report refers. The medical device model is
defined as: the value used to represent one medical device or a family of medical
devices to group many variations that have shared characteristics (source; IMDRF).
N N N N N
d Catalogue/Reference number The Catalogue/Reference number for the medical device to which this report
refers. The Catalogue/Reference number is defined as: The value given by the
Regulated Entity to identify the specific medical device as it relates to its form/fit,
function, and process (i.e., manufacturing processes requiring differentiation for
distribution control (e.g., sterilization, component material, reprocessing, etc.)
(source IMDRF).
N N N N N
Please note:
- “Regulated Entities” include: Sponsors, Applicants, Manufacturers, Labellers,
Suppliers and Distributors, Maintenance/Servicing) (IMDRF).
https://health.ec.europa.eu/document/download/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en
10
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
The catalogue, reference number is found on the device label or accompanying
packaging to identify a particular product.
e Serial number The serial number for the medical device to which this report refers. The serial
number is defined as: A unique sequence of numbers or letter in a series used to
identify an individual unit of a medical device (source; IMDRF).
N N N N N
f Lot/batch number The Lot/batch number for the medical device to which this report refers i.e.: A
value that represents one or more components or finished devices that consist of a
single type, model, class, size, composition, or software version that are
manufactured under essentially the same conditions and are intended to have
uniform characteristics and quality within specified limits (source; IMDRF)".
N N N N N
g Software version
The software version is defined as: The value given by the applicant to identify a
specific revision of the software, including Software as a Medical Device (SaMD). N N N N N
Please note:
- “Applicant” means any natural or legal person who is legally responsible for the
medical device regulatory submission under the country or jurisdiction’s
legislation (IMDRF).
h Firmware version The firmware version is defined as: The value given by the applicant to identify a
specific revision of the firmware (including SaMD (source; IMDRF)). N N N N N
i Device manufacturing date The date of manufacture for the medical device to which this report refers. N N N N N
j Device expiry date The expiry date for the medical device to which this report refers. N N N N N
k Date when device was implanted If available, the implant date for the medical device to which this report refers- if
exact date is unknown, please add timeframe. N N N N N
Please note that it is important to ensure the logic chronological order of the dates in 2.3.k
and 2.3.l (i.e. an implant can be explanted only after it has been implanted)
l Date when device was explanted If available, the explant date for the medical device to which this report refers- if
exact date is unknown, please add timeframe. N N N N N
Please note that it is important to ensure the logic chronological order of the dates in 2.3.k
and 2.3.l (i.e. an implant can be explanted only after it has been implanted)
m If precise implant/explant dates are
unknown, provide the duration of
implantation
How long was the implant in the patient? (months/years)
Please provide best estimate. If day is unknown, month and year are acceptable. If
month and day are unknown, year is acceptable.
N N N N N
n Implant facility The healthcare facility where the device was implanted. N N N N N
o Explant facility The healthcare facility where the device was explanted. N N N N N
p Notified body (NB) ID number(s) (if
applicable)
The most current identification number for the Notified Body that granted the CE
mark for this device. If two Notified Bodies are involved, please enter both values
in the field provided.
Y N N Y Y
Please note:
- Only applicable for devices where a NB is involved in the conformity assessment
procedure (i.e., devices other than MDD Class I without measuring function or
sterile; IVD general; MDR class I without measuring function, sterile or reusable
surgical instruments; IVDR class A without sterile conditions).
- This field appears as mandatory by default for final reportable, final non
reportable and combined initial and final report types. When the risk class is
selected in fields 2.4. c or d, then the field 2.4.p either remains mandatory or
becomes not mandatory depending the applicable MDR /IVDR requirements.
- Link; 'Risk Class and NB' properties' Guidance table for MIR section 2.3p. the
mandatory properties presented in this table (see link above) are only applicable
to devices for which a NB is involved in the conformity assessment procedure.
p Notified body (NB) certificate
number(s) of device (if applicable)
The certificate number from the notified body(ies) above. If two Notified Bodies,
please enter both values in the fields provided (For example, a kit containing
multiple components). Y N N Y Y
Please note:
- Only applicable for devices where a NB is involved in the conformity assessment
procedure (see also link; 'Risk Class and NB' properties')
11
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
q Please indicate the date of one of
the following:
What was the date of either: the first Declaration of Conformity; or the device first
CE marked, or first placed on the market and/or put into service or if software, the
first date available for download.
For CE marked devices: the date of the first Declaration of Conformity or the date
the CE Marking was affixed (these dates are usually considered to coincide but
may not). For Custom-Made devices: the date the device was first placed on the
market and/or put into service. Please indicate to which option the date refers.
N N N N N
Please note: this is a single choice.
2.4 Risk class of device when placed on market
Select which regulation the device was conforming to when it was placed on the market,
irrespective of when the actual incident occurred.
a Applicable legislation unknown Y Y Y Y Y One of either a, b, c or d.
b This device has been placed on the
market before the implementation
of the MDD/AIMDD/IVDD
Select if the device was placed on the market before the implementation of the
MDD (93/42/EEC), AIMDD (90/385/EEC) or IVDD (98/79/EC).
It is possible that on the market there are devices which were placed on the
market before June 1993 or active implants implanted before 1990 or an IVD
before 1998.
Y Y Y Y Y
Please note:
- Enter one of either a, b, c or d
- If unknown please use 2.4a.
c MDD/AIMDD/IVDD risk class Indicate the relevant Risk Class for the medical device to which this report refers.
If unknown please select risk class to the best of your knowledge and update on
follow up/final.
Auto populates when entering UDI-DI in Section 2.1.a.
Y Y Y Y Y
Please note:
- Enter one of either a, b, c or d
- If unknown please use 2.4a.
d MDR/IVDR risk class MDR and IVDR fields set up as according to proposal in EUDAMED
The information will be attached to the UDI (Basic UDI-DI) in the UDI database;
therefore, it will come automatically with the Basic UDI-DI (except for custom-
made device which will not have a Basic UDI-DI). If unknown please select risk
class to the best of your knowledge and update on follow up/final.
Auto populates when entering UDI-DI in Section 2.1.a.
Y Y Y Y Y
Please note:
- Enter one of either a, b, c or d
- Type chosen can be multiple.
- If unknown please use 2.4a.
e Did this device continue to be placed
on the EU market after MDR / IVDR
date of application?
This field is only applicable to directive devices, solely to identify if this medical
device is a legacy device.
Y Y Y Y Y
Please note:
- Becomes mandatory when 2.4c is selected e.g. MDD (93/42/EEC) or IVDD
(98/79/EC) compliant devices.
f 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."
If yes is selected, the 2 free text-boxes become mandatory. Please fill in the
requested information.
• Competent authority name or European Medicines Agency consulted by
the notified body for the conformity assessment procedure described in
Article 52(9) MDR or Article 52(10) MDR. For companion diagnostics
(CD); the competent authority name or European Medicines Agency
consulted by the notified body for the CD conformity assessment
procedure described in Article 48(3) IVDR or Article 48(4) IVDR.
• Name(s) of the medicinal substance(s) / product(s), tissue(s), cell(s) of
human origin or their derivative(s) associated with the device. For
companion diagnostics please provide the International Non-proprietary
Name (INN) of the corresponding medicinal product.
Y Y Y Y Y
Please note:
- This field is applicable to MDR (all classes) and IVDR devices (classes C or D +
companion diagnostics). A bullet selected in 2.4 a, b or c disactivates section 2.4
f (grey area).
- Covers both medicinal products and ancillary substances.
- This field is not applicable to substances of animal origin.
- For a proper functioning of fields 4.1.b. and 4.2. c as regards the “suspicion of the
relationship between the incident and the medicinal product …”, it is required to
prior provide an answer “Yes” or “No” in field 2.4.f. when this field appears as
mandatory.
Some incidents may be related to:
12
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
- a substance which, if used separately, would be considered to be a medicinal
product. For medical devices incorporating a medicinal substance, the action of
the substance is ancillary to that of the device.
- substances of human origin (SOHO) i.e. derivatives of blood, tissues or cells of
human origin utilised for the manufacturing of the device. For the identification
of the involved tissue or cells, please add the Single European Code (SEC).
- medicinal product of a companion diagnostic.
If yes selected, preliminary data or final conclusions concerning the relationship between
the incident and the substances described are requested in section 4.1 b and/or 4.2 c,
depending on the status of the report submitted.
2.5 Market distribution of device (region/country)
a Market distribution of device
(region/ country)
Indicate in which countries the medical device has been distributed to
• please fill to the best of your knowledge.
• Auto populates when entering UDI-DI in Section 2.1.a.
Y N N Y N
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)
Accessories enable the medical device to be used for its intended purpose and
may or may not be from the same manufacturer as the device being reported on.
Provide as much information as possible, including manufacturer names if
different. This field may be used to alert the relevant NCA of the need for a
separate MIR form from the other manufacturer(s) involved.
1.3.c, 2.6: If you are certain of the device that caused the incident, then this
device is what should be reported on the form.
- If unsure, then submit separate MIR reports on all other devices from
the same manufacturer that could have played a role and fill out 1.3.1c.
- List any associated accessories in 2.6a which could be from a different
manufacturer if known and 2.6 b for any other devices (which could be
from a different manufacturer if known).
N N N N N
Please note:
- If the accessory itself is a possible cause of the incident, a separate MIR shall be
submitted for that accessory.
- For incident reporting an accessory has to be registered in EUDAMED.
- Section 1.3c provides further details on the reporting obligations regarding the
relevant accessories used with the 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)
Associated devices are those used together/in combination and may or may not
be from the same manufacturer as the device being reported on. This field may be
used to alert the relevant NCA of the need for a separate MIR form from the
(other) manufacturer(s) involved.
- An example is the use of a CT scanner used in combination with contrast
medium; contrast injectors; tubing, syringes etc.
- If the manufacturer is confident that some devices present cannot be
the cause of the incident, it will not submit a separate MIR for each
device, but will specify them in this section.
- Provide as much information as possible, including manufacturer names
if different.
N N N N N
Please note:
- If the NCA has doubts about the conclusion made by the manufacturer,
submitting an additional MIR for other devices specified in section 2.6. might be
required.
- Section 1.3c provides further details on the reporting obligations regarding the
relevant associated devices used with the device being reported on.
13
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
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)
Describe the incident including any relevant information that might impact the
understanding or evaluation of the incident. This should cover the first observable
incident or possibly a later secondary but more serious incident, or maybe both.
Describe the condition/outcome of a patient after the incident, including the
degree of wellness and the need for continuing care, medication, support,
counselling, or education.
Y Y Y Y Y
3.2 Medical device problem information
a IMDRF Medical device problem
codes (Annex A)
(see also chapter 3, link)
"Medical Device Problems" codes describe the problems (malfunction,
deterioration of function, failure) of medical devices that have occurred in pre- or
post-market contexts. The aim is to always provide the most appropriate coding
level.
Please enter the "most relevant" Annex A level 3 observation of the medical
device problem as "Choice 1". While providing the "most relevant" code as
"Choice 1" is mandatory, a manufacturer may choose to add up to 5 additional,
different Annex A codes that describe the medical device problem(s). These other
codes are optional.
In case you cannot assign an adequate Annex A level 3 observation but a suitable
Annex A level 2 code could be assigned, please use this Annex A level 2 code as
"Choice 1". If it is not possible to assign an adequate Annex A level 2 code, select
a suitable code of Annex A level 1 as "Choice 1". For some medical device
problems, Annex A does not provide all 3 levels of terms and codes. In those
cases, coding of Annex level 1 or 2 would be acceptable without justification.
Since coding with IMDRF Annex A terms/codes is a mandatory requirement,
“Choice 1” in Section 3.2a needs to be populated and cannot be left blank.
Y Y Y Y Y
Please note:
- The PDF does not check correct IMDRF code or IMDRF code combinations. It is
the responsibility of the manufacturer to provide relevant coding.
Code A26
- This code can be used if there is not enough information available yet to classify
the device problem on initial or follow-up MIR reporting.
Code A27
- If you deem no code (on any hierarchy level) to be appropriate to describe the
medical device problem, please enter code “A27 - Appropriate Term/Code Not
Available” as "Choice 1" to indicate that the device problem is not adequately
described by any other term.
- Code A27 should not be used unless there is no other feasible code. However, in
case this code is used, please briefly explain why the current terms/codes are not
appropriate to describe the medical device problem. This information may be
used to propose new IMDRF Adverse Event Terminology terms and codes which
could be incorporated in the nomenclature as part of the ongoing maintenance
process.
b Number of patients involved The number of patients involved. Please note that Patient could also mean user or
other third person. If issue occurred without patient involvement e.g. on External
Quality Assessment Samples, this field should be “0”.
N N N N N
14
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
c What is the current location of the
device
The current location of the device involved in this event- please describe the
location if none of the provided options are applicable. Y Y Y Y Y
Please note that this is single choice.
d Operator of device at the time of the
incident
Indicate who was operating the device at the time of the event: healthcare
professional, patient, Other: please describe the operator if none of the provided
options are applicable.
N N N N N
Please note that this is single choice.
e Usage of device (as intended) Indicate the usage of the device at the time the incident occurred. Please select
Other if none of the provided options are applicable and describe the usage.
Examples: Compassionate / humanitarian use.
For reagents/test strips: select “initial use” as the assay itself will not be re-used
(i.e., another drop of reagent or another reaction support is going to be used for
the next test/sample).
For instruments/analysers: select “Reuse of a reusable medical device” as the
analyser is going to be used several years to perform testing.
N N N N N
f Remedial actions taken by
healthcare facility, patient or user
subsequent to the incident
Describe any action taken by the health practitioner, healthcare facility, patient or
user to avoid a further occurrence of this problem. This may include explant of an
implanted device; prescription medicine taken as a consequence of the incident;
the recall of patients for further testing; or the provision of changed or improved
advice on the use of the device or the quarantine of possibly affected devices /
device involved in this incident.
N N N N N
3.3 Clinical information
a IMDRF 'Health Effect' terms and
codes (Annex E, F)
(see also chapter 3, link)
Health Effect codes describe the consequence(s) of the reported incident on the
patient involved. You can choose up to 6 codes to describe: 1) clinical signs,
symptoms, conditions and 2) health impact. The aim is to always provide the most
appropriate coding level.
Please enter the most relevant lowest level observation as Choice 1. You may
chose up to 5 other different codes that describe the health effect.
In case you can't find a level 3 observation, but a suitable level 2 code, then please
use this code as Choice 1 and explain briefly in the text box why no level 3 code
was chosen.
Since coding with IMDRF Annex E, F terms/codes is a mandatory requirement,
“Choice 1” in Section 3.3a needs to be populated and cannot be left blank.
Y Y Y Y Y
Please note:
- The PDF does not check correct IMDRF code or IMDRF code combinations. It is
the responsibility of the manufacturer to provide relevant coding.
Code E2401 or F24
- These codes can be used if there is not enough information available yet to
classify the health impact on initial or follow-up MIR reporting.
Code “E2402 or F28.
- If you deem no code (on any hierarchy level) to be appropriate to describe
'Health Effect', please enter code “E2402 or F28 - Appropriate Term/Code Not
Available” as "Choice 1" to indicate that the 'Health Effect' is not adequately
described by any other term.
- Code “E2402 or F28 should not be used unless there is no other feasible code.
However, in case this code is used, please briefly explain why the current
terms/codes are not appropriate to describe the 'Health Effect'. This information
may be used to propose new IMDRF Adverse Event Terminology terms and codes
which could be incorporated in the nomenclature as part of the ongoing
maintenance process.
b Age of the patient at the time of the
incident, if applicable
The age of the patient is in years or months or days. Months & days should only
be used for patients under the age of 1. For all others, please use years. N N N N N
15
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
c Gender The gender of the patient involved in this event (Female, Male, Other, Not
specified). N N N N N
d Body Weight (Kg) The patient's weight in kilograms (Please leave blank if unknown). N N N N N Only integral values are possible.
e Height (cm) The patient's height in centimetres (Please leave blank if unknown). N N N N N Only integral values are possible.
f List any of the patient's prior health
condition or medication that may be
relevant to this incident
List any health condition that may be relevant to the incident or medication taken
by the patient either regularly or at the specific day/period when the incident
occurred.
N N N N N
3.4 INITIAL REPORTER
a Role of initial reporter Please select the role of the person that initially reported the incident. This can be
for example: healthcare professional of facility, patient, user etc. Y Y Y Y Y
b Name of the health care facility
where incident occurred
The name of the healthcare facility where this incident occurred. If this incident
did not occur in a health care facility you don’t need to fill out this field. N N N N N
c Healthcare facility report number (if
applicable)
The Report reference number used by the healthcare facility concerned when
they reported the incident. N N N N N
d Contact's first name The name of the contact at the healthcare facility where this event occurred. If
this incident did not occur in a health care facility you don’t need to fill out this
field.
N N N N N
e Contact's last name The name of the contact at the healthcare facility where this event occurred. If
this incident did not occur in a health care facility you don’t need to fill out this
field.
N N N N N
f Email The email address for the initial reporter. If this incident did not occur in a health
care facility you don’t need to fill out this field. N N N N N
g Phone The telephone number for the initial reporter. If this incident did not occur in a
health care facility you don’t need to fill out this field. N N N N N
h Country The country where this event occurred.
Y Y Y Y Y
Please note:
- If other please specify; the tickbox provides an option for a country not presented
in the list.
i Street The street of the initial reporter
If this incident did not occur in a health care facility you don’t need to fill out this
field.
N N N N N
j Street number The street number of the initial reporter
If this incident did not occur in a health care facility you don’t need to fill out this
field.
N N N N N
k Address complement The address of the initial reporter
If this incident did not occur in a health care facility you don’t need to fill out this
field.
N N N N N
l PO Box The PO box of the initial reporter
If this incident did not occur in a health care facility you don’t need to fill out this
field.
N N N N N
m City name The name of the city of the initial reporter.
If this incident did not occur in a health care facility you don’t need to fill out this
field.
N N N N N
n Postal code The postal or zip code of the initial reporter.
If this incident did not occur in a health care facility you don’t need to fill out this
field.
N N N N N
4. Manufacturer analysis
4.1 Manufacturer’s preliminary comments
16
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
a For initial and follow-up reports:
preliminary results and conclusions
of manufacturer’s investigation
Details of any preliminary analysis you can provide.
N Y Y N N
b 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?
If yes is selected in section 2.4f i.e.
• for this device a scientific opinion has been asked in accordance with
Article 52(9) MDR or Article 52(10) MDR..
• for companion diagnostics(CD); the competent authority name or
European Medicines Agency which delivered the scientific opinion or
was consulted by the notified body for the CD conformity assessment
procedure described in Article 48(3) IVDR or Article 48(4) IVDR.
this field becomes mandatory for initial and/or follow up reports.
N Y Y N N
Please note:
- This field is only applicable for devices referred to in section 2.4f.
- For a proper functioning of fields 4.1.b. and 4.2. c as regards the “suspicion of the
relationship between the incident and the medicinal product …”, it is required to
prior provide an answer “Yes” or “No” in field 2.4.f. when this field appears as
mandatory.
- If tick box “Yes” is selected in field 4.1.b. but “No” was selected under field 2.4.f.,
please reconsider your selection of tick box “No” under 2.4.f.
- Regarding the preliminary data available for initial and follow-up reports, the
answer should be “No” by default unless already available data or information
collected seems to or leads to a reasonable suspicion.
- For Companion Diagnostics select yes if there is a suspicion or confirmation that
the corresponding medicinal substance contributed to the incident.
c Initial actions (corrective and/or
preventive) implemented by the
manufacturer
Details of initial corrective and/or preventive actions implemented by the
manufacturer. Please add n/a if not applicable yet. N N Y N N
d What further investigations do you
intend in view of reaching final
conclusions?
Provide details of any further investigations you plan to undertake to reach the
root cause. Please add n/a if not applicable yet. N N Y N N
4.2 Cause investigation and conclusion
a For Final (Serious incident)
Description of the manufacturer’s
evaluation concerning possible root
causes/causative factors and
conclusion
A report of your analysis of the device involved in this serious incident.
If no analysis or investigation of the device could be carried out, for example if the
device was not returned, then indicate the most probable root cause analysis.
Please be clear whether you are describing the root cause or most probable root
cause. (Standard practice is for CA's to routinely ask for most probable root cause
when it is unclear). To avoid extensive communication, give the information here.
In many cases, evaluation of the actual device is not feasible. Instead the
investigation may focus on "surrogate devices", i.e. devices belong to the same
batch or lot as the device, to another lot/batch. Testing of model variants may
also be indicated in specific cases. Please describe the devices investigated and, if
applicable, tested-- Other investigative means than testing may include interviews
with the user/operator of the device, control of production records etc. Your
investigations and conclusions should be explained and their credibility and
plausibility justified.
If you refer to an existing CAPA please provide the reference or identification
number of that CAPA in 4.2.g.
Y N N Y N
b For Final (Non-reportable)
Fill out rationale for why this is
considered not reportable
If the incident was deemed not reportable, please indicate here why. You do not
have to fill out any other additional fields.
e.g. Two devices are involved and one of them was proved not to contribute to
the serious incident as a result of the investigation.
N N N N Y
Please note:
- Please refer to the guidance document MDCG 2023-3: Questions and Answers on
vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on
medical devices for further information on what is considered as a Final (Non-
reportable incident).
c Is root cause confirmed?
- 1st section; Please indicate if there is evidence of a causal link to the
medical device problem.
Y N N Y N
Please note:
- The second section is only applicable for devices referred to in section 2.4f
17
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
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?
- 2nd section; Suspicion or confirmation of a relationship…; Please
indicate if there is a possible causal link 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.
- For a proper functioning of fields 4.1.b. and 4.2. c as regards the “suspicion of the
relationship between the incident and the medicinal product …”, it is required to
prior provide an answer “Yes” or “No” in field 2.4.f. when this field appears as
mandatory.
- If tick box “Yes” is selected in field 4.2.c. but “No” was selected under field
2.4.f., please reconsider your selection of tick box “No” under 2.4.f
- If tick box “Yes” is selected in field 4.1.b, Suspicion of a relationship…, a rejection
or confirmation in the 2nd section of 4.2c is a mandatory requirement for final
reportable and combined reports.
- For Companion Diagnostics select yes if there is a suspicion or confirmation that
the corresponding medicinal substance contributed to the incident.
d Has the risks assessment been
reviewed?
Indicate if the risk assessment has been reviewed after this serious incident and
provide a rationale why the risk assessment is still adequate or why no review is
required
Y N N Y N
Please note:
- If “No” is selected in the 1st section, then the corresponding text box in the 1st
section becomes mandatory.
- If “Yes” is selected in the 1st section, then “yes/ No” and the text box with the
title “Results of the assessment” become mandatory in the 2nd section.
e IMDRF “Cause Investigation” terms
and codes (Annex B, C, D)
(see also chapter 3, link)
"Cause Investigation" codes describe the Type of investigation (B), findings (C) and
the outcome (D) of the Investigation conducted. The aim is to always provide the
most appropriate coding level.
Please enter the "most relevant" Annex B, C, D level 3 observation of Cause
investigation as "Choice 1".
While providing the "most relevant" code as "Choice 1" is mandatory, a
manufacturer may choose to add up to 5 additional, different Annex codes that
describe the Cause investigation. These other codes are optional.
In case you cannot assign an adequate Annex B, C, D level 3 observation but a
suitable Annex B, C, D level 2 code could be assigned, please use this level 2 code
as "Choice 1". If it is not possible to assign an adequate Annex B, C, D level 2 code,
select a suitable code of level 1 as "Choice 1".
Some Annex B, C, D codes does not provide all 3 levels of terms and codes. In
those cases, coding of Annex level 1 or 2 would be acceptable without
justification.
Since coding with IMDRF Annex B, C, D terms/codes is a mandatory requirement,
“Choice 1” in Section 4.2e needs to be populated and cannot be left blank.
Y N N Y N
Please note:
- The PDF does not check correct IMDRF code or IMDRF code combinations. It is
the responsibility of the manufacturer to provide relevant coding.
Cause investigation conclusion code “D17:
- If you deem no code (on any hierarchy level) to be appropriate to describe the
Investigation Conclusion, please enter code “D17 - Appropriate Term/Code Not
Available” as "Choice 1" to indicate that the device problem is not adequately
described by any other term.
- Code “D17 should not be used unless there is no other feasible code. However, in
case this code is used, please briefly explain why the current terms/codes are not
appropriate to describe the Cause investigation conclusion. This information may
be used to propose new IMDRF Adverse Event Terminology terms and codes
which could be incorporated in the nomenclature as part of the ongoing
maintenance process.
18
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
f IMDRF Component codes (Annex G) (see also chapter 3, link)
"Component codes" codes describe medical device component characteristics.
The aim is to always provide the most appropriate coding level.
Please enter the "most relevant" Annex G level 3 observation of Cause
investigation as "Choice 1".
While providing the "most relevant" code as "Choice 1" is mandatory, a
manufacturer may choose to add up to 5 additional, different Annex G codes that
describe medical device components. These other codes are optional.
In case you cannot assign an adequate Annex G, level 3 observation but a suitable
Annex G level 2 code could be assigned, please use this level 2 code as "Choice 1".
If it is not possible to assign an adequate Annex G level 2 code, select a suitable
code of level 1 as "Choice 1".
Some Annex G codes does not provide all 3 levels of terms and codes. In those
cases, coding of Annex level 1 or 2 would be acceptable without justification.
Since coding with IMDRF Annex G terms/codes is a mandatory requirement,
“Choice 1” in Section 4.2f needs to be populated and cannot be left blank.
Y N N Y N
Please note:
- The PDF does not check correct IMDRF code or IMDRF code combinations. It is
the responsibility of the manufacturer to provide relevant coding.
Component code G07002:
- If you deem no code (on any hierarchy level) to be appropriate to describe
Component codes, please enter code “G07002 - Appropriate Term/Code Not
Available” as "Choice 1" to indicate that the device problem is not adequately
described by any other term.
- Code G07002 should not be used unless there is no other feasible code. However,
in case this code is used, please briefly explain why the current terms/codes are
not appropriate to describe the Component codes. This information may be used
to propose new IMDRF Adverse Event Terminology terms and codes which could
be incorporated in the nomenclature as part of the ongoing maintenance
process.
g Description of remedial
action/corrective action/preventive
action/field safety corrective action
(FSCA)
Describe any remedial, corrective (article 2(67)/2(70) MDR/IVDR) and/or
preventative action(s) taken as a result of this event and/or your investigation.
Please also include any reference number available for the remedial, corrective
and/or preventive actions, including CAPA and/or FSCA (article 2(68)/2(71)
MDR/IVDR).
If this serious incident is covered by an existing CAPA or FSCA, please provide the
reference or identification number. Note that FSCA reference number should also
be given in section 1.3.1d.
Y N N Y N
Please note:
- A FSCA initiated has to be reported separately by using the FSCA form.
- For final and combined initial & final reports please add n/a if not applicable.
h Time schedule for the
implementation of the identified
actions
Describe your time schedule for any corrective, preventative or other actions
arising from this event and your investigation.
N N N N N
i Final comments from the
manufacturer on Cause investigation
and conclusion
Enter your final comments on this serious incident for cause investigation and
conclusion.
Y N N Y N
4.3 Similar serious incidents (for Final serious incidents)
4.3.1 Use of IMDRF terms and codes for identifying similar serious incidents
19
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
a Identification of similar serious
incidents using IMDRF Adverse Event
Reporting terms and codes.
Are identified as similar serious incidents when:
• The same device type/variant of a given manufacturer, and
• Having the same medical device problem (IMDRF medical device
problem; Annex A) and the same investigation finding (IMDRF
investigation finding; Annex C), if the investigation finding of the
original serious incident is known,
• Or having the same medical device problem (Annex A) if the
investigation finding is unknown;
notwithstanding the outcome for the patient, user or other person.
When using the IMDRF Adverse Event Reporting terms and codes, it is preferable
to identify and provide similar serious incident data based on the most relevant
codes (this should be choice 1 in each coding section).
Alternatively: Where the IMDRF 'Annex A medical device problem' and 'Annex C
investigation findings' codes are not used to describe similar serious incident data,
please detail how the similar serious incidents data has been calculated and the
rationale for not using the IMDRF codes specified.
• For example, for some implantable devices, it may be appropriate to
provide similar serious incident data based on the IMDRF Health effect
codes (Clinical signs, symptoms and conditions, Annex E; Health impact,
Annex F).
• If using these health effect codes, please use the most relevant term
from either Annex E or Annex F (and not a combination of both) for
identifying similar serious incidents.
Y N N Y N
For combined and final reportable MIR:
- Annex A tick box is mandatory for final reportable and combined reports
when the manufacturer has identified there were similar serious incidents
with same Annex A code.
- Annex C tick box is optional and can, where applicable, be selected after
having selected Annex A.
- When no similar serious incidents have been registered so far or when no Annex
A code corresponds to the medical device problem encountered, please select
the tick box "Other" and provide explanations in the free text field.
- When the tick box "Other" has been selected, then the red box for Annex A
"choice 1" is removed.
4.3.2 Use of in-house terms/codes for identifying similar serious incidents (until June 2025)
a If similar serious incidents were not
identified by IMDRF codes but by in-
house codes, please indicate the
code / combination of codes below.
Are identified as similar serious incidents when:
• the same device type/variant of a given manufacturer, and
• having the same root cause investigational finding, and
• the same medical device problem,
• the root cause investigational finding of the original serious incident is
known, or having the same medical device problem if the root cause
investigational finding is unknown;
Notwithstanding the outcome for the patient, user or other person.
When using in-house codes and terms, it is preferable to identify and provide
similar serious incident data based on the most relevant code and term.
Other:
Where the in-house 'medical device problem' and 'root cause evaluation' terms
and codes are not used to describe similar serious incident data, please detail how
the similar serious incidents data has been calculated and the rationale for not
using these terms/codes.
For example, for some implantable devices, it may be appropriate to provide
similar serious incident data based on in-house patient problem terms and codes.
N N N N N
Please note:
This field is no longer editable as the deadline of June 2025 has already passed.
Only IMDRF terms and codes can be used to identify similar serious incidents (see field
4.3.1.a.)
20
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
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:
How have you defined and categorised similar serious incidents? Specify medical
device identification e.g. based on model, product platform, batches, serial
number range etc... that you believe is the most appropriate for categorisation of
relevant similar serious incidents.
Y N N Y N
Please note that this is single choice.
b Indicate to what criteria the number
of devices on the market (also
known as denominator data) is
based on (tick the most appropriate)
Indicate what the numbers of devices on the market are based on.
For example, number of devices sold or numbers of devices installed, number of
tests performed; number of episodes of use for reusable devices (e.g. the number
of episodes of use multiplied by the number of devices in service or sold).
When selecting the criteria for the number of devices on the market in section
4.3.3b, manufacturers may use cumulative data for the (horizontal) time periods
in section 4.3.3c. when selecting one of the following bullets and clearly explained
in section 4.3.3d (mandatory):
- “Active installed base”
- “Number of devices implanted”
- “Units distributed from the date of declaration of conformity”
- “Devices placed on the market or put into service”
- “Other -describe”
When selecting the criteria for the number of devices on the market in 4.3.3b,
competent authorities do not consider the following appropriate for the use of
cumulative data for the (horizontal) time periods in section 4.3.3c
- “Units distributed within each time period”
- “Number of tests performed”
- “Number of episodes of use”
When these criteria are selected, the number of devices on the market should be
presented within each time period.
Y N N Y N
Please note
- This is single choice.
- The bullet selected i.e. the criteria the number of devices on the market are
based on must be clearly explained in section 4.3.3d (a mandatory requirement
for combined and final reportable incident reports).
- In cases of uncertainties which denominator data should be chosen, please
discuss with the coordinating National Competent Authority: Manufacturers
should work with the CA on the most appropriate denominator data for the
device (or variant) concerned.
c Enter the number of similar serious
incidents (SI) and devices on the
market for the indicated time
periods
Enter, for the indicated time periods, the number of similar serious incidents (SI)
and number of devices on market (i.e. denominator data should align with 4.3.3.b
above). The default time period for similar serious incident data is yearly unless:
1. a different time period has been specified by the European Medical
Device Vigilance Experts Group or
2. the device has not been on the European market for more than three
years.
In the event of (2) please clearly indicate the time periods being used to provide
similar serious incident data.
If selecting yearly periods, the first selection will automatically set the other time
periods.
Y N N Y N
c Start date The default time period as described above-If a manufacturer believes there is
good reason not to use the default time period the manufacturer should approach
their CA requesting agreement to use the new reporting time periods with all
Competent Authorities- in the future this information/guidance can be included in
the DSVGs.
Y N N Y N
Only Mandatory if using different dates from calendar years.
21
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
c End date The default time period as described above-If a manufacturer believes there is
good reason not to use the default time period the manufacturer should approach
their CA requesting agreement to use the new reporting time periods with all
Competent Authorities- in the future this information/guidance can be included in
the DSVGs.
Y N N Y N
Only Mandatory if using different dates from calendar years.
c Number of similar serious incidents
that occurred within each time
period:
Indicate the annual cumulative number of similar serious incidents in the vertical
direction. The number of similar serious incidents need to be filled out for more
than one column, if the device has been on the market for more than one year. If
none please add zero (type in "0").
The purpose of the data supplied by the manufacturer is for the competent
authority to be able to perform risk evaluation. It needs to be possible to see the
number of serious incidents per device.
Y N N Y N
Please note:
- Geographical (vertical) numbers of similar incidents should always be cumulative
(country of incident is part of the EEA+TR+XI and the latter is part of the world).
- Reporting of the number of similar incidents should always be within each time
period (horizontal) and not cumulative data for all time periods.
c Number of devices on market Indicate the annual number of devices placed on market or devices in use based
on the selected option for the denominator data in section 4.3.3.b.
The number of similar devices need to be filled out for more than one column, if
the device has been on the market for more than one year. If none please add
zero (type in "0"). Y N N Y N
Please note:
- Geographical (vertical) numbers of devices on the market should always be
cumulative (country is part of the EEA+TR+XI and the latter is part of the world).
- Reporting of the number of devices on the market could be within each time
period or cumulative data for all time periods based on the selected option for
the denominator data selected in section 4.3.3.b and clearly explained in section
4.3.3d (mandatory requirement).
c In country where serious incident
occurred
In the country where the serious incident occurred. If none please add zero (type
in "0"). Y N N Y N
c EEA + TR + XI In EEA + TR + XI. If none please add zero (type in "0")
This number will include the number directly above
Y N N Y N
c World In the world. If none please add zero (type in "0")
This number will include the number directly above.
Y N N Y N
d Comments on how similar serious
incidents and associated number of
devices on the market were
determined
Based on the selected option for the denominator data in section 4.3.3.b. and the
data presented in section 4.3.3c, the manufacturer should clearly explain in this
section 4.3.3d how data on similar serious incidents and associated number of
devices on the market were determined.
Y N N Y N
5. General Comments Please use this section for any further comments or information that has not
already been provided in the earlier sections of this report form. N N N N N
Coded Summary of report (Will be
auto populated from previous
selections)
This section will be auto populated from previous sections for a quick overview of
the coded serious incident.
Please note:
- There is nothing to be filled out here by the manufacturer.
22
Help text Mandatory properties Comments
Section Combined
initial & final Initial Follow Up
Final
(Reportable
incident)
Final (Non-
reportable
incident)
Before submitting Check the form:
This is an automated mandatory field check. Use this button to screen the
document for finding mandatory fields with no data input. Output depends on
type of report.
Signature:
The signature is optional. It can be performed by using either a certificate
(individual or corporate) or a virtual signature to be added in the box for
signature.
- The “Check the form” can be performed at any moment of the MIR drafting and the
fields remain editable after the validation process.
- When a pop-up message with “check the form” appears, the submission of the MIR is
blocked as long as the mandatory fields in Pop-up are not filled in.
- The list of displayed errors in the pop-up is limited to a maximum of 20 notifications.
When several errors are indicated at the same time, pleaser consider only the error
detailed in the lower part of the text.
- Adobe Acrobat Professional is necessary for signing and XML data import/export.
- After signing the document, the fields are fixed. It is no longer possible to modify data.
- The ‘date’ field is auto populated when signing the form. Date order (e.g. YYYY-MM-DD)
is depending the geographical location (country & region settings) of the
- computer of the user.
Export and / or submission Save as XML / PDF:
Use this button to save the document respectively in XML / PDF format within a
specific location on your computer.
Submit XML / PDF by email:
Use this button to automatically initiate a blank email with respectively the
document in XML / PDF format attached.
Please note:
- After using “Submitting the PDF by email” or “Submitting the XML by email”
the fields are fixed. It is no longer possible to modify data.
Bottom of the MIR
Please note:
- The free-text fields of the MIR PDF are not auto-expandable but the scroll down
button for each free-text field allows for the reading of the whole field text when
drafting it.
- To get an overview of the content of all the free-text fields, the whole list and
content of each free text field for which text has been added is displayed as
“extra fields” at the bottom of the MIR.
- The whole list of “extra fields” is provided in section 6 (List of extra fields) of this
document. As field 4.3.2.a. is no longer editable (deadline of June 2025 already
passed), it is not displayed as an “extra-field”.
- For ease of work with the MIR PDF and in particular with the free-text fields, a
document explaining how to split the MIR PDF in 2 independent parts is provided
in section 7 (Guide for splitting the MIR PDF with Adobe Acrobat) of this
document.
23
Rules
Section Question Default status Description
1.3.1 a free text disabled Enabled if "Other, please specify" is selected
1.3.1 f free text disabled Enabled if "The incident occurred within a PMCF/PMPF investigation,
Yes " is selected
1.3.4 a-l submitter enabled Auto populated if the submitter of the report is a Manufacturer or Authorised representative
2.2 a free text disabled Enabled if "Other, please specify" is selected
2.3 b Nomenclature text disabled Enabled if "2.2 a EMDN" is selected.
2.3 q Year and Month disabled Enabled when any of the alternatives are selected
2.4 d MDR Type (Multiple choice) disabled Enabled if an MDR class is selected.
2.4 d IVDR Type (Multiple choice) disabled Enabled if an IVDR class is selected.
2.4 e Did this device continue to be placed on the EU market after MDR / IVDR date of
application?
disabled Enabled if an MDD or IVDD risk class in section 2.4 c is selected.
2.4 f Does “the device fulfill 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 EMA has been
consulted in accordance with section 5.2 of Annex IX IVDR or section 3.k of Annex
X IVDR."
disabled Enabled if "Yes" is selected
3.2 c free text disabled Enabled if "Other" is selected
3.2 d free text disabled Enabled if "Other, please describe" is selected
3.2 e free text disabled Enabled if "Other" is selected
3.4 a free text disabled Enabled if "Other, please specify" is selected
3.4 h free text ("If other, please specify") disabled Enabled if "Other" is selected"
4.2 d If 'No', rationale for no review required disabled Enabled if "No" ("Has the risk assessment been reviewed?") is selected
4.2 d If the risk assessment has been reviewed, is it still adequate? disabled Enabled if "Yes" ("Has the risk assessment been reviewed?") is selected
4.3.1 a Annex C (Choice 1) disabled Enabled if Annex A (of the same question) is selected
4.3.1 a free text disabled Enabled if "Other" is selected
4.3.2 a Annex C Code/Term disabled Enabled if "Code for most relevant medical device problem" (of the same question) is specified
4.3.2 a free text disabled Enabled if "Other" is selected
4.3.3 b free text disabled Enabled if "Other - describe" is selected
24
EMDN coding & IMDRF Adverse Event Terminology
Q&A Useful links
EMDN European Medical Device Nomenclature (used in MIR Section 2.2a)
Question 1 What is the European Medical Device Nomenclature (EMDN)?
The EMDN is a terminology and coding system for medical devices and IVD description. Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and
Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the European Medical Device Nomenclature (EMDN) aims at supporting the
functioning of the European database on medical devices (EUDAMED). Among its various uses, it will be utilised by manufacturers for the registration of medical
devices in EUDAMED, where it will be associated to each Unique Device Identifier – Device Identifier (UDI-DI). As the EMDN primarily serves regulatory purposes
to support MDR and IVDR requirements, it also plays a key role in MDR/IVDR device documentation and technical documentation, sampling of technical
documentation conducted by notified bodies, post-market surveillance, vigilance and post-market data analysis, etc. It is intended to support all actors in their
activities under the MDR/IVDR and provides key device descriptions to patients as regards their own devices and all other devices available on the market and
registered in EUDAMED.
European Medical Device Nomenclature (EMDN)
Devices Nomenclature Finder EUDAMED EMDN Device Nomenclature Finder
Question 2 How do I gain access to EMDN information?
The entirety of the EMDN is accessible to all stakeholders, free of charge. It can hence be utilised by a non-exhaustive list of stakeholders such as manufacturers,
patients, research organisations, practitioners, hospitals, pharmacies etc. The EMDN can be accessed and downloaded in pdf and excel format and via the
European Commission’s website page for MDCG documents..
EMDN Q & A MDCG 2021-12
AE Terms The International Medical Device Regulators Forum (IMDRF) Adverse Event(AE) Terminology
Question 3 What is the IMDRF Adverse Event Terminology?
The IMDRF AE terminology is a terminology and coding system for adverse events developed by the International Medical Device Regulators Forum. It wil help
regulatory agencies by enabling them to analyze safety information about medical devices with higher accuracy and reliability, and by facilitating communication
about medical device adverse events between regulatory agencies using various languages. It will help regulated industry by reducing the burden of managing
safety information on medical device products and reducing the burden of preparing multiple adverse event reports and other safety information to regulatory
agencies. Widespread use of an improved coding system will improve signal detection by adverse event management systems enabling a faster response by both
manufacturers and regulatory agencies, and reduce the burden on manufacturers in reporting common, well known adverse events.
Question 4 Where can I find adverse event terms and codes?
Detailed descriptions and information about the IMDRF AE Terminology can be found on the IMDRF web browser. IMDRF Adverse Event Terminology Web Browser
Used in MIR section:
MIR Section: 3.2 (a) Annex A: Medical device problem Annex A: Medical Device Problem
MIR Section: 4.2 (e) Annex B: Cause investigation: Type of investigation Annex B: Cause Investigation - Type of Investigation
MIR Section: 4.2 (e) Annex C: Cause investigation: Investigation findings Annex C: Cause Investigation - Investigation Findings
MIR Section: 4.2 (e) Annex D: Cause investigation: Investigation conclusion Annex D: Cause Investigation – Investigation Conclusion
MIR Section: 3.3. (a) Annex E: Clinical signs, symptoms and conditions Annex E: Health Effects - Clinical Signs and Symptoms or Conditions
MIR Section: 3.3. (a) Annex F: Health impact Annex F: Health Effects - Health Impact
MIR Section: 4.2. (f) Annex G: Components Annex G: Medical Device Component
https://health.ec.europa.eu/document/download/e724bca0-7035-426e-9672-bd2404ebb6a7_en?filename=md_q-a_emdn_en.pdf
https://ec.europa.eu/tools/eudamed/#/screen/nomenclatures
https://health.ec.europa.eu/document/download/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en?filename=md_2021-12_en.pdf
https://www.imdrf.org/working-groups/adverse-event-terminology
https://www.imdrf.org/working-groups/adverse-event-terminology/annex-medical-device-problem
https://www.imdrf.org/working-groups/adverse-event-terminology/annex-b-cause-investigation-type-investigation
https://www.imdrf.org/working-groups/adverse-event-terminology/annex-c-cause-investigation-investigation-findings
https://www.imdrf.org/working-groups/adverse-event-terminology/annex-d-cause-investigation-investigation-conclusion
https://www.imdrf.org/working-groups/adverse-event-terminology/annex-e-health-effects-clinical-signs-and-symptoms-or-conditions
https://www.imdrf.org/working-groups/adverse-event-terminology/annex-f-health-effects-health-impact
https://www.imdrf.org/working-groups/adverse-event-terminology/annex-g-medical-device-component
25
Question 5 The reported incident is unique or a suitable IMDRF AE term is missing. How do I fulfil the mandatory field requirements of the MIR?
“If exceptionally no relevant IMDRF code is available or specific enough, then provide additional information in the accompanying free text field. This is a way to
propose new IMDRF terms which could be incorporated in the nomenclature during a maintenance session.
26
Medical Device Risk Class and Notified body properties
Guidance table for MIR section 2.3p. Mandatory properties presented in this table are only applicable for devices where a NB is involved in the conformity assessment procedure.
Combined initial & final Initial Follow Up
Final
(Reportable incident)
Final (Non-
reportable incident)
MDD/AIMDD/IVDD
AIMD active implant Y N N Y Y
MDD class III Y N N Y Y
MDD class IIb Y N N Y Y
MDD class IIa Y N N Y Y
MDD class I N N N N N
MDD class Is Y (for part “sterile”) N N Y (for part “sterile”) Y (for part “sterile”)
MDD class Im Y (for part “measuring function”) N N Y (for part “measuring function”) Y (for part “measuring function”)
MDD class Ism Y (for part "sterile" and part
“measuring function”) N N Y (for part "sterile" and part
“measuring function”)
Y (for part "sterile" and part
“measuring function”)
IVD Annex II List A Y N N Y Y
IVD Annex II List B Y N N Y Y
IVD devices for self-testing Y N N Y Y
IVD general N N N N N
MDR/IVDR
MDR class III Y N N Y Y
MDR class IIb Y N N Y Y
MDR class IIa Y N N Y Y
MDR class I N N N N N
MDR class I + “sterile
conditions” Y N N Y Y
MDR class I + “measuring
function” Y N N Y Y
MDR class I + “reusable
surgical instruments” à yes Y N N Y Y
IVDR class D Y N N Y Y
IVDR class C Y N N Y Y
IVDR class B Y N N Y Y
IVDR class A N N N N N
IVDR class A + "sterile
conditions"
Y N N Y Y
27
XML Element Field Map: list of XML elements corresponding to the MIR field labels
Section XML element
1. Administrative information
1.1 Responsible competent authority in which country the incident occurred
a Name of receiving national competent authority (NCA) ncaName
b EUDAMED Number of NCA ncaEudamedNum
c Reference number assigned by NCA for this incident ncaReportNo
d Reference number assigned by EUDAMED for this incident refNumEudamed
1.2 Date, type, and classification of incident report
a Date of report submission reportDate
b Date of incident adverseEventDateFrom
adverseEventDateTo
c Manufacturer awareness date of the incident mfrAwarenessDate
d Manufacturer awareness date of reportability mfrAwarenessReportDate
e Type of Report reportType
f In case of initial and follow-up reports, please indicate the expected date of next report reportNextDate
g Classification of incident eventClassification
1.3 Submitter information
1.3.1 a Submitter of the report statusReporter
1.3.1 a Submitter of the report Other text reporterOtherText
b Manufacturer's reference number for this incident mfrRef
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
ncaRefMultiDev
eudamedRefMultiDev
mfrRefMultiDev
d If this incident is covered under an FSCA, please provide the relevant numbers:
ncaRefFSCA
eudamedRefFSCA
mfrRefFSCA
e Periodic Summary Report (PSR) ID psrId
f The incident occurred within a PMCF/PMPF investigation pmcfpmpfQuestion
pmcfpmpfId
1.3.2 Manufacturer information
a Manufacturer Organisation name mfrName
b Single Registration Number (SRN) mfrSRN
c Contact's first name mfrContactPersonFirstName
d Contact's last name mfrContactPersonSecondName
e E-mail mfrEmailAddress
f Phone mfrPhone
g Country mfrCountry
h Street mfrOrgStreet
i Street number mfrOrgStreetNum
j Address complement mfrAddress
k P.O Box mfrOrgPOBox
l City name mfrCity
m Postcode mfrPostcode
1.3.3 Authorized representative information
a Authorised representative Organisation name ARName
b Single Registration Number (SRN) ARSRN
c Contact's first name ARContactPersonFirstName
d Contact's last name ARContactPersonSecondName
e E-mail AREmailAddress
f Phone ARPhone
g Country ARCountry
h Street ARStreet
i Street number ARStreetNum
j Address complement ARAddress
k P.O Box ARPOBox
l City name ARCity
m Postcode ARPostCode
1.3.4 Submitter’s details if not also manufacturer or authorised representative
a Registered commercial name of company reporterOrgName
b Contact's first name reporterContactPersonFirstName
c Contact's last name reporterContactPersonSecondName
d E-mail reporterOrgEmailAddress
e Phone reporterOrgPhone
f Country reporterOrgCountry
g Street reporterOrgStreet
28
h Street number reporterOrgStreetNum
i Address complement reporterOrgAddress
j P.O Box reporterOrgPOBox
k City name reporterOrgCity
l Postcode reporterOrgPostcode
2. Medical Device Information
2.1 Unique Device Identification (UDI)
a (Master) UDI-DI/Eudamed ID udiDI
a Issuing entity udiDI_Entity
b UDI production identifier udiPI
c Basic UDI-DI/Eudamed DI udiDIBasic
c Issuing entity Basic_Entity
d Unit of use UDI-DI udiDIUnitUse
d Issuing entity UnitofUse_Entity
2.2 Categorisation of device
a Medical device nomenclature nomenclatureSystem
nomenclatureSystemOther
b Medical device nomenclature code nomenclatureCode
2.3 Description of device and commercial information
a Medical device name (Brand/Trade/Proprietary or Common name) brandName
b Description of the device and its intended use deviceDescription
b Nomenclarture deviceNomenclature
c Model modelNum
d Catalogue/Reference number catalogNum
e Serial number(s) serialNum
f Lot/batch number(s) batchNum
g Software version deviceSoftwareVer
h Firmware version deviceFirmwareVer
i Device manufacturing date deviceMfrDate
j Device expiry date deviceExpiryDate
k Date when device was implanted ImplantedDateFrom
ImplantedDateTo
l Date when device was explanted ExplantedDateFrom
ExplantedDateTo
m If precise implant/explant dates are unknown, provide the duration of implantation
numYears
numMonths
numDays
n Implant facility implantFacilityName
o Explant facility explantFacilityName
p Notified body (NB) ID number(s) (if applicable ) nbIdNum, nbIdNum2
p Notified body (NB) certificate number(s) of device (if applicable) nbCertNum, nbCertNum2
q Please indicate the date of one of the following: deviceMarketDateType
deviceMarketDate (year, month)
2.4 Risk class of device when placed on market
a Applicable legislation AppLegislationUnknown
b This device has been placed on the market before the implementation of the MDD/AIMDD/IVDD deviceClass
c MDD/AIMDD/IVDD risk class deviceClassMDD
deviceClassIVDD
29
d MDR/IVDR risk class
deviceClassMDR
deviceClassIVDR
deviceClassMDRType:
implantable
activedevice
intendedtoadminister
sterileconditions
measuringfunction
reusable
software
systems
procedurepacks
custommade
non-medical
deviceClassIVDRType:
selftesting
nearpatienttesting
professionaltesting
companiondiagnostics
reagent
software
instrument
sterileconditions
e Did this device continue to be placed on the EU market after MDR / IVDR date of application DevicePlacedMarket
f
Does the device fulfill 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."
Competent authority name or European Medicines Agency which delivered the scientific opinion or
was consultedby 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
DeviceFulfill
CompetentAuthName
RelevantName
2.5a Market distribution of device (region/ country)
a All countries distributionEEA
a All EEA, Turkey and Northern Ireland distribution_all
a other otherCountries
2.6 Use of accessories, associated devices or other devices
a Relevant accessories used with the device being reported on, if applicable deviceAccessories
b Relevant associated devices used with the device being reported on, if applicable deviceAssociated
3. Incident information derived from initial reporter
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
eventDescription
3.2 Medical device problem information
a IMDRF Medical device problem codes (Annex A) imdrfCodeChoice1-6
imdrfCodeMissing
b Number of patients involved numPatientsInvolved
c What is the current location of the device currentDeviceLocation
currentDeviceLocationOtherText
d Operator of device at the time of the incident deviceOperatorAtEvent
deviceOperatorAtEventOther
e Usage of device deviceUsage
deviceUsageOther
f Remedial actions taken by healthcare facility, patient or user subsequent to the incident patientRemedialAction
3.3 Clinical information
a IMDRF 'Health Effect' terms and codes (Annex E, F)
imdrfClinicalCodeChoice1-6
imdrfHealthCodeChoice1-6
imdrfMissingCodeHealthEffect
b Age of the patient at the time of incident
numYears
numMonths
numDays
c Gender Gender
d Body Weight (Kg) massKG
e Height (cm) heightCM
f List any of the patient's prior health condition or medication that may be relevant to this incident patientPriorMedication
30
3.4 INITIAL REPORTER
a Role of initial reporter initialReporterRole
initialReporterRoleOther
b Name of the health care facility where incident occurred healthcareFacilityName
c Healthcare facility report number (if applicable) healthcareFacilityRepNum
d Contact's first name healthcareFacilityContactPersonFirstName
e Contact's last name healthcareFacilityContactPersonSecondName
f Email healthcareFacilityEmail
g Phone healthcareFacilityPhone
h Country healthcareFacilityCountry
healthcareFacilityCountryOther
i Street healthcareFacilityStreet
j Street number healthcareFacilityStreetNum
k Address complement healthcareFacilityAddress
l P.O Box healthcareFacilityPOBox
m City name healthcareFacilityCity
n Postcode healthcareFacilityPostcode
4. Manufacturer analysis
4.1 Manufacturer’s preliminary comments
a For initial and follow-up reports: preliminary results and conclusions of manufacturer’s investigation manufacturersPrelimAnalysis
b 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? suspicionRelationShip
c
d
Initial actions (corrective and/or preventive) implemented by the manufacturer
What further investigations do you intend in view of reaching final conclusions
manufacturersInitialCorrecAction
furtherInvestigations
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 rootCauses
b For Final (Non-reportable incident)- Fill out rationale for why this is considered not reportable manufacturersWhyNotReportable
c
Is root cause confirmed
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?
rootCauseConfirmed
relationShipIncidentSubstance
d Has the risks assessment been reviewed?
riskAssReviewed
rationaleNoReview
riskAssAdequate
riskAssResults
e IMDRF ‘Cause Investigation' terms and codes (Annex B, C, D)
imdrfTypeInvestigationCodeChoice1-8
imdrfInvestigationFindingsCodeChoice1-6
imdrfInvestigationConclusionCodeChoice1-6
imdrfMissingCodeCauseInvestigation
f IMDRF Component codes (Annex G) imdrfComponentCodeChoice1-6
imdrfMissingComponentCodes
g Description of remedial action/corrective action/preventive action/Field Safety Corrective Action correctiveAction
h Time schedule for the implementation of the identified actions correctiveActionSchedule
i Final comments from the manufacturer on cause investigation and conclusion manufacturersFinalComments
4.3 Similar (serious) incidents (for Final Reportable incident)
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. T
similarIncImdrfCodesAnnexA
similarIncImdrfCodesAnnexC
similarIncOtherReportingCodes
similarIncOtherReportingCodesText
4.3.2 Use of in-house terms/codes for identifying similar (serious) incidents
a If similar incident were not identified by IMDRF codes but by in-house codes, please indicate the
code/combination of codes below.
similarIncMdCodesChoice1Code
similarIncMdCodesChoice1Term
similarIncRootCouseCodesChoice1Code
similarIncRootCouseCodesChoice1Term
similarIncOtherInHouseCodes
similarIncOtherInHouseCodesText
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:
similarVariant
similarVariantDetails
b Indicate to what criteria the number of devices on the market (also known as denominator data) is
based on ( tick the most appropriate)
numberBasedOn
numberBasedOnOther
c Start date timePeriodN - timePeriodN-3 (startDate)
c End date timePeriodN - timePeriodN-3 (endDate)
31
c In country where incident occurred (Number of similar incidents) timePeriodN - timePeriodN-3 (countrySimInc)
c In country where incident occurred (Number of devices on market) timePeriodN - timePeriodN-3
(countrySimDev)
c EEA + candidate countries + CH + TR (Number of similar incidents) timePeriodN - timePeriodN-3
(eeaChTrSimInc)
c EEA + candidate countries + CH + TR (Number of devices on market) timePeriodN - timePeriodN-3
(eeaChTrSimDev)
c World (Number of similar incidents) timePeriodN - timePeriodN-3 (worldSimInc)
c World (Number of devices on market) timePeriodN - timePeriodN-3 (worldSimDev)
d Comments on how similar (serious) incidents and associated number of devices on the market were
determined howWereDetermined
5. General Comments
General Comments AdditionalComments
Coded Summary of report (Will be auto populated from
previous selections)
Submission part
Date sCreateTimeStamp
32
List of extra fields (displayed at the end of the MIR)
Sections
2. Medical device information
2.6 Use of accessories, associated devices or other devices
a Relevant accessories used with the device being reported on, if applicable
b Relevant associated devices used with the device being reported on, if applicable
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
3.2 Medical device problem information
a IMDRF Medical device problem codes (Annex A)
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)
f List any of the patient's prior health condition or medication that may be relevant to this incident
4. Manufacturer analysis
4.1 Manufacturer’s preliminary comments
a For initial and follow-up reports: preliminary results and conclusions of manufacturer’s investigation
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
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
d Has the risks assessment been reviewed?
d Has the risks assessment been reviewed?
e IMDRF ‘Cause Investigation' terms and codes (Annex B, C, D)
f IMDRF Component codes (Annex G)
g Description of remedial action/corrective action/preventive action/Field Safety Corrective Action
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 Reportable incident)
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. T
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:
b Indicate to what criteria the number of devices on the market (also known as denominator data) is
based on ( tick the most appropriate)
d Comments on how similar (serious) incidents and associated number of devices on the market were
determined
5. General Comments
General Comments
33
Guidance for splitting the MIR PDF with Adobe Acrobat
34
35
MIR Helptext
Rules
EMDN coding & IMDRF Adverse Event Terminology
Medical Device Risk Class and Notified body properties
XML Element Field Map: list of XML elements corresponding to the MIR field labels
List of extra fields (displayed at the end of the MIR)
Guidance for splitting the MIR PDF with Adobe Acrobat
16.04.2026
Datei
PD
WF Neu I 2026:
Empfehlungen des BfArM
zu den Anträgen zu neuen Messzahlen
im Rahmen der Allgemeinen Verwaltungsvorschrift
zur Ermittlung von Packungsgrößen nach § 5
PackungsV
Stand: 15.04.2026
Seite 2 von 22
1. Budesonid_Kinder ...........................................................................................................................................................3
2. Leniolisib ..............................................................................................................................................................................7
3. Nerandomilast ................................................................................................................................................................ 10
4. Nirmatrelvir und Ritonavir .................................................................................................................................... 13
5. Remibrutinib ................................................................................................................................................................... 17
6. Tarlatamab ........................................................................................................................................................................ 20
Seite 3 von 22 1. Budesonid_Kinder
Budesonid ist in der amtlichen ATC-Klassifikation 2026 in der Gruppe A07E „Intestinale
Antiphlogistika“ der ATC-Code A07EA06 zugeteilt. Die DDD beträgt 9 mg O; 1,5 mg SL; 16 mg O
bei primärer Immunglobulin-A-Nephropathie; Standarddosis: 1 DE R.
Sachverhalt für das Fertigarzneimittel
Jorveza 0,2 mg/mL
Darreichungsform: Suspension zum Einnehmen; 0,2 mg Budesonid /mL
Anwendungsgebiete laut Fachinformation:
Jorveza 0,2 mg/ml Suspension zum Einnehmen ist indiziert zur Behandlung der eosinophilen
Ösophagitis (EoE) bei Kindern und Jugendlichen im Alter von 2 bis 17 Jahren.
Patientengruppe laut Fachinformation: Kinder, Jugendliche
Dosierung laut Fachinformation:
Kinder im Alter von 2 bis 11 Jahren:
Die empfohlene Tagesdosis beträgt 1 mg Budesonid, aufgeteilt in zwei Einzeldosen: morgens und
abends jeweils 2,5 ml Suspension (entsprechend 0,5 mg Budesonid).
Jugendliche von 12 bis 17 Jahren:
Die empfohlene Tagesdosis beträgt 2 mg Budesonid, aufgeteilt in zwei Einzeldosen: morgens und
abends jeweils 5 ml Suspension (entsprechend 1 mg Budesonid).
Die übliche Dauer der Einleitungstherapie beträgt 12 Wochen. Bei Patienten, die innerhalb von
12 Wochen nicht ausreichend auf die Therapie ansprechen, kann die Behandlung auf bis zu 24
Wochen verlängert werden.
CHMP Opinion: 26.02.2026 (EMADOC-1700519818-2896158)
Datum der Erteilung der Zulassung: geplant für Mai 2026
Markteinführung: geplant für Q4/2026
Seite 4 von 22 Aktuell gültige Messzahlen
Berechnung der Messzahlen nach VwV
Unter Berücksichtigung von Anlage 2
- Abschnitt „4.2 Patientenkollektive“
- Abschnitt „4.8 Initial- und Erhaltungstherapie“
- Abschnitt „4.9 Spannbreiten bei der Applikationshäufigkeit, -menge und / oder im
Dosierungsintervall“
N1 = 5 ml (≙ 1 mg Budesonid) x 10 Tage = 50 (Initialtherapie)
N2 = 2,5 ml (≙ 0,5 mg Budesonid) x 30 Tage = 75 (Erhaltungstherapie)
N3 = 2,5 ml (≙ 0,5 mg Budesonid) x 100 Tage = 250 (Erhaltungstherapie)
Messzahlen für das Packungsgrößenkennzeichen N3
Im zu prüfenden Antrag wird die auf 42 Tage limitierte Packungsgröße/ Reichdauer der Messzahl
für das Packungsgrößenkennzeichen N3 mit der begrenzten Haltbarkeit von 6 Wochen (42 Tage)
nach Anbruch der Flasche begründet.
Die Messzahlen der Anlage 1 orientieren sich grundsätzlich an der wirkstoff- und
indikationsbezogenen Reichdauer für die entsprechende Pharmakotherapie und sollen für alle
vergleichbaren Arzneimittel gelten.
Inwieweit –galenikbedingte- und ggf. auf das spezifische (antragsgegenständige) Arzneimittel
begrenzte Gründe in eine Entscheidung zur Festlegung reichdauerorientierter Messzahlen mit
einbezogen werden sollen, ist im Rahmen des Beratungsverfahrens durch die AG ATC/ DDD im
weiteren Verlauf zu klären.
Beantragte Messzahlen durch den Antragsteller
Beantragt wird die Aufnahme der wirkstoffbezogenen Ausnahme „Budesonid für Kinder“ in
Abschnitt 2 „Nicht abgeteilte Darreichungsformen zur oralen Anwendung“ unter „Corticoide
(Interna)“ mit den Messzahlen:
N1 = 50
N2 = 150
Seite 5 von 22 N3 = 250
Entscheidungsempfehlung
Es wird empfohlen, die wirkstoffbezogene Ausnahme „Budesonid für Kinder“ in Abschnitt 2
„Nicht abgeteilte Darreichungsformen zur oralen Anwendung“ unter „Corticoide (Interna)“ mit
den Messzahlen N1 =50, N2 =150 und N3 = 500 aufzunehmen.
Begründung
Die vom BfArM ermittelten Messzahlen entsprechen der VwV.
Stellungnahmen zu den Empfehlungen des BfArM:
Im aktuellen Workflow wurde eine Stellungnahme eingereicht.
Die Anwendung der Zusatzregeln 4.8. und 4.9. ist nicht zutreffend (Details der SN siehe
anliegend).
Schlussempfehlung des BfArM („Beschlussvorlage“)
Der Stellungnahme wird gefolgt.
Berechnung der Messzahlen nach VwV
Unter Berücksichtigung von Anlage 2
- Abschnitt „4.2 Patientenkollektive“
N1 = 2,5 ml (≙ 0,5 mg Budesonid) x 2 x 10 Tage = 50
N2 = 2,5 ml (≙ 0,5 mg Budesonid) x 2 x 30 Tage = 150
N3 = 2,5 ml (≙ 0,5 mg Budesonid) x 2 x 100 Tage = 500
Es wird empfohlen, die wirkstoffbezogene Ausnahme „Budesonid für Kinder“ in Abschnitt 2
„Nicht abgeteilte Darreichungsformen zur oralen Anwendung“ unter „Corticoide (Interna)“ mit
den Messzahlen N1 =50, N2 =150 und N3 = 500 aufzunehmen.
Seite 6 von 22
Seite 7 von 22 2. Leniolisib
Leniolisib ist in der amtlichen ATC- Klassifikation 2024 in der Gruppe L03AX „Andere
Immunstimulanzien“ der ATC-Code L03AX22 zugeordnet. Eine DDD ist nicht vergeben.
Sachverhalt für das Fertigarzneimittel
Joenja 70 mg Filmtabletten
Darreichungsform: Filmtabletten
Anwendungsgebiete laut Fachinformation:
Behandlung des aktivierten Phosphoinositid-3-Kinase-Delta-Syndroms (APDS) bei Erwachsenen
und Jugendlichen ab 12 Jahren und einem Gewicht von 45 kg oder mehr.
Patientengruppe laut Fachinformation: Erwachse und Jugendliche ab 12 Jahre
Dosierung laut Fachinformation:
Die empfohlene Dosis beträgt 70 mg Leniolisib zweimal täglich im Abstand von etwa 12 Stunden.
CHMP Opinion: 26.03.2026 (EMA/CHMP/28350/2026)
Datum der Erteilung der Zulassung: geplant für Juli 2026
Markteinführung: geplant für Juli 2026
Arzneimittel-Härtefallprogramme/ Compassionate Use: Zugang der bestätigten Anzeige per
06.06.2023
Seite 8 von 22 Aktuell gültige Messzahlen
Derzeit ist keine geeignete Postion in Abschnitt 4 der Anlage 1 vorhanden, der sich das
Arzneimittel fachlich sinnvoll zuordnen lässst.
Berechnung der Messzahlen nach VwV
Unter Berücksichtigung von Anlage 2
- Abschnitt „4.2 Patientenkollektive“
N1 = 2 x 1 Filmtablette x 10 Tage = 20
N2 = 2 x 1 Filmtablette x 30 Tage = 60
N3 = 2 x 1 Filmtablette x 100 Tage = 200
Beantragte Messzahlen durch den Antragsteller
Beantragt wird die Aufnahme der wirkstoffbezogenen Ausnahme „Leniolisib“ in Abschnitt 1
„Abgeteilte orale Darreichungsformen“ in die neue Position „Immunstimulanzien“ mit den
Messzahlen:
N1 = 20
N2 = 60
N3 = 200
Entscheidungsempfehlung
Es wird empfohlen, die Position „Leniolisib“ als wirkstoffbezogene Ausnahme in Abschnitt 1
„Abgeteilte orale Darreichungsformen“ unter die Position „Immunstimulanzien“ mit den
Messzahlen N1 = 20, N2 = 60 und N3 = 200 aufzunehmen.
Begründung
Die vom BfArM ermittelten Messzahlen entsprechen der VwV.
Stellungnahmen zu den Empfehlungen des BfArM:
Im aktuellen Workflow wurde eine Stellungnahme eingereicht. (Details s. Anlage)
Seite 9 von 22
Schlussempfehlung des BfArM („Beschlussvorlage“)
Die Entscheidungsempfehlung des BfArM bleibt unverändert.
Begründung
Leniolisib ist in der amtlichen ATC- Klassifikation 2026 in der Gruppe L03AX „Andere
Immunstimulanzien“ eingeordnet.
In dieser Gruppe werden Immunstimulanzien verschiedener Wirkstoffklassen klassifiziert, so
dass die Aufnahme einer übergeordneten, „generischen“ Position u.E. nicht sachgerecht möglich
ist.
Grundsätzlich stimmt das BfArM dem Grundgedanken zu, Positionen in den Fällen „generisch“
auszuweisen oder zusammenzuführen, in denen es möglich ist und dies in Folge ohne
Auswirkungen auf den Bestandsmarkt bleibt.
Seite 10 von 22 3. Nerandomilast
Nerandomilast ist in der amtlichen ATC-Klassifikation 2026 in der Gruppe Immunsuppressiva
„Selektive Immunsuppressiva“ der ATC-Code L04AA61 zugeteilt. Eine DDD ist nicht vergeben.
Sachverhalt für das Fertigarzneimittel
Jascayd 9 mg Filmtabletten
Jascayd 18 mg Filmtabletten
Darreichungsform: Filmtablette
Anwendungsgebiete laut Fachinformation/Zusammenfassung der Merkmale: Jascayd ist
indiziert zur Behandlung von erwachsenen Patienten mit idiopathischer Lungenfibrose (IPF).
Jascayd ist indiziert zur Behandlung der progredienten Pulmonalen Fibrose (PPF) und zur
Verringerung des Sterberisikos bei erwachsenen Patienten mit PPF.
Patientengruppe laut Fachinformation/Zusammenfassung der Merkmale: Erwachsene
Dosierung laut Fachinformation/Zusammenfassung der Merkmale: Die empfohlene Dosis
beträgt 18 mg zweimal täglich, in einem Abstand von ungefähr 12 Stunden.
Auf Basis der individuellen Patiententoleranz kann die Dosis auf 9 mg zweimal täglich reduziert
werden.
CHMP Opinion: liegt noch nicht vor
Datum der Erteilung der Zulassung: geplant für Juni 2026
Markteinführung: geplant für August 2026
Seite 11 von 22 Aktuell gültige Messzahlen
Berechnung der Messzahlen nach VwV
Unter Berücksichtigung von Anlage 2
- Abschnitt „4.3 verschiedene Wirkstärken“
N1 = 2x 1 Filmtablette à 18 mg Nerandomilast/Tag x 10 Tage= 20
N2 = 2x 1 Filmtablette à 18 mg Nerandomilast/Tag x 30 Tage= 60
N3 = 2x 1 Filmtablette à 18 mg Nerandomilast/Tag x 100 Tage= 200
Beantragte Messzahlen durch den Antragsteller
Beantragt wird die Aufnahme der wirkstoffbezogenen Ausnahme „Nerandomilast“ in Abschnitt 1
„Abgeteilte orale Darreichungsformen“ in die Position „Immunsuppressiva“ mit den Messzahlen:
N1 =20
N2 = 60
N3 = 200
Entscheidungsempfehlung
Vorbehaltlich der Positive Opinion wird empfohlen, die Position „Nerandomilast“ als
wirkstoffbezogene Ausnahme in Abschnitt 1 „Abgeteilte orale Darreichungsformen“ in die
Position „Immunsuppressiva“ mit den Messzahlen N1 = 20, N2 = 60 und N3 = 200 aufzunehmen.
Seite 12 von 22 Die finale Fachinformation muss zusammen mit einer schriftlichen Bestätigung des
Antragstellers, dass die SmPC, die dem BfArM bei Antragstellung vorlag, hinsichtlich
der für die Bestimmung der Packungsgrößen maßgeblichen Angaben unverändert
geblieben ist, innerhalb der in der VwV in §4 Satz (7) genannten Frist dem BfArM nachgereicht
werden. Anderenfalls kann der Antrag dann erneut gestellt werden, wenn absehbar ist, dass die
Zulassung innerhalb des vorgegebenen Zeitraums erteilt werden kann.
Begründung
Die vom BfArM ermittelten Messzahlen entsprechen der VwV.
Stellungnahmen zu den Empfehlungen des BfArM:
Im aktuellen Workflow wurden keine Stellungnahmen eingereicht.
Schlussempfehlung des BfArM („Beschlussvorlage“)
Dem Antrag kann nicht stattgegeben werden, da bis zum o. g. Termin vor Erstellung der
Beschlussvorlage keine positive Opinion vorgelegt wurde.
Es wird daher empfohlen, dass der Antragsteller den Antrag dann erneut stellt, wenn absehbar
ist, dass die positive Opinion innerhalb des vorgegebenen Zeitraums vorgelegt werden kann.
Seite 13 von 22 4. Nirmatrelvir und Ritonavir
Nirmatrelvir und Ritonavir ist in der amtlichen ATC-Klassifikation 2026 in der Gruppe
„Antivirale Mittel zur systemischen Anwendung, Direkt wirkende antivirale Mittel,
Proteasehemmer“ der ATC-Code „J05AE30“ zugeteilt. Die DDD beträgt 0,6 g O bezogen auf
Nirmatrelvir.
Sachverhalt für das Fertigarzneimittel
Paxlovid® 150 mg + 100 mg Filmtabletten
Darreichungsform: Filmtablette
Anwendungsgebiete laut Fachinformation:
Paxlovid wird angewendet zur Behandlung einer Coronavirus-Krankheit 2019 (COVID‑19) bei
Erwachsenen und pädiatrischen Patienten ab einem Alter von 6 Jahren mit einem Körpergewicht
von mindestens 20 kg, die keine zusätzliche Sauerstoffzufuhr benötigen und ein erhöhtes Risiko
haben, einen schweren COVID-19-Verlauf zu entwickeln.
Patientengruppe laut Fachinformation: Erwachsene und pädiatrische Patienten ab einem Alter
von 6 Jahren.
Dosierung laut Fachinformation:
Erwachsene
Die empfohlene Dosierung bei Erwachsenen beträgt 300 mg Nirmatrelvir (zwei 150 mg
Tabletten) und 100 mg Ritonavir (eine 100 mg Tablette) zur gleichzeitigen Einnahme alle 12
Stunden über einen Zeitraum von 5 Tagen.
Pädiatrische Patienten ab einem Alter von 6 Jahren mit einem Körpergewicht von mindestens 20 kg
Die empfohlene Dosierung bei pädiatrischen Patienten ab einem Alter von 6 Jahren mit einem
Körpergewicht von mindestens 20 kg ist in Tabelle 1 dargestellt.
Pädiatrische Patienten im Alter von ≥ 6 Jahren mit einem Körpergewicht von ≥ 40 kg
300 mg Nirmatrelvir (zwei 150-mg-Tabletten) mit 100 mg Ritonavir (eine 100-mg-Tablette)
zur gleichzeitigen Einnahme alle 12 Stunden über einen Zeitraum von 5 Tagen
Pädiatrische Patienten im Alter von ≥ 6 Jahren mit einem Körpergewicht von ≥ 20 bis < 40 kg
150 mg Nirmatrelvir (eine 150-mg-Tablette) mit 100 mg Ritonavir (eine 100-mg-Tablette)
zur gleichzeitigen Einnahme alle 12 Stunden über einen Zeitraum von 5 Tagen
Seite 14 von 22 Datum der Erteilung der Zulassung: 28.01.2022
Markteinführung: 25.02.2022
Aktuell gültige Messzahlen
Berechnung der Messzahlen nach VwV
Unter Berücksichtigung von Anlage 2
- Abschnitt 4.7. „Fest definierte bzw. maximal mögliche Behandlungsdauer“
- Abschnitt 4.2. „Patientenkollektive“
N1 = 2x (2 Filmtabletten à 150 mg Nirmatrelvir + 1 Filmtablette à 100 mg Ritonavir)/ Tag x 5
Tage= 30
N2 = -
N3 = -
Seite 15 von 22 Beantragte Messzahlen durch den Antragsteller
Beantragt wird die Aufnahme der wirkstoffbezogenen Ausnahme „Kombination aus
Nirmatrelvir und Ritonavir“ in Abschnitt 1 „Antivirale Mittel – Unterposition
Proteaseinhibitoren“ mit den Messzahlen:
N1 =30
N2 = -
N3 = -
Entscheidungsempfehlung
Es wird empfohlen, die Position „Kombination aus Nirmatrelvir und Ritonavir“ als
wirkstoffbezogene Ausnahme in Abschnitt 1 „Abgeteilte orale Darreichungsformen“ in die
Position „Antivirale Mittel – Unterposition Proteaseinhibitoren“ mit den Messzahlen N1 =30, N2
= - und N3 = - aufzunehmen.
Seite 16 von 22
Begründung
Die vom BfArM ermittelten Messzahlen entsprechen der VwV.
Stellungnahmen zu den Empfehlungen des BfArM:
Im aktuellen Workflow wurden keine Stellungnahmen eingereicht.
Schlussempfehlung des BfArM („Beschlussvorlage“)
Die Entscheidungsempfehlung des BfArM bleibt unverändert.
Seite 17 von 22 5. Remibrutinib
Remibrutinib ist in der amtlichen ATC-Klassifikation 2026 in der Gruppe L04AA „Selektive
Immunsuppressiva“ der ATC-Code L04AA60 zugeordnet. Eine DDD ist nicht vergeben.
Sachverhalt für das Fertigarzneimittel
Tbd; Filmtablette 25 mg à Remibrutinib
Darreichungsform Filmtabletten
Anwendungsgebiete laut Fachinformation/Zusammenfassung der Merkmale:
Tbd Filmtablette 25 mg ist zur Behandlung der chronischen spontanen Urtikaria (CSU) bei
erwachsenen Patienten indiziert, die trotz Behandlung mit H1-Antihistaminika weiterhin
Symptome aufweisen.
Patientengruppe laut Fachinformation: Erwachsene
Dosierung laut Fachinformation:
Die empfohlene Dosis von Tbd beträgt 25 mg, die zweimal täglich oral eingenommen werden.
CHMP Opinion: liegt noch nicht vor
Datum der Erteilung der Zulassung: geplant für Q2/ 2026
Markteinführung: geplant für Q2/ 2026
Seite 18 von 22 Aktuell gültige Messzahlen
Berechnung der Messzahlen nach VwV
Unter Berücksichtigung von Anlage 2
N1 = 2 x 1 Filmtablette à 25 mg Remibrutinib / Tag x 10 Tage = 20
N2 = 2 x 1 Filmtablette à 25 mg Remibrutinib / Tag x 30 Tage = 60
N3 = 2 x 1 Filmtablette à 25 mg Remibrutinib / Tag x 100 Tage = 200
Beantragte Messzahlen durch den Antragsteller
Beantragt wird die Aufnahme der wirkstoffbezogenen Ausnahme „Remibrutinib“ in Abschnitt 1
„Abgeteilte orale Darreichungsformen“ in die Position „Dermatika (Interna)“ mit den
Messzahlen:
N1 = -
N2 = 60
N3 = 180
Entscheidungsempfehlung
Vorbehaltlich der „CHMP Positive Opinion“/ des „EoP letter“ wird empfohlen, die Position
„Remibrutinib“ in Abschnitt 1 „Abgeteilte orale Darreichungsformen“ in die Position
„Immunsuppressiva“ mit den Messzahlen: N1 = 20, N2 = 60 und N3 = 200 aufzunehmen.
Seite 19 von 22 Die finale Fachinformation muss zusammen mit einer schriftlichen Bestätigung des
Antragstellers, dass die SmPC, die dem BfArM bei Antragstellung vorlag, hinsichtlich
der für die Bestimmung der Packungsgrößen maßgeblichen Angaben unverändert
geblieben ist, innerhalb der in der VwV in §4 Satz (7) genannten Frist dem BfArM nachgereicht
werden. Anderenfalls kann der Antrag dann erneut gestellt werden, wenn absehbar ist, dass die
Zulassung innerhalb des vorgegebenen Zeitraums erteilt werden kann.
Begründung
Die vom BfArM ermittelten Messzahlen entsprechen der VwV.
Stellungnahmen zu den Empfehlungen des BfArM:
Im aktuellen Workflow wurden keine Stellungnahmen eingereicht.
Schlussempfehlung des BfArM („Beschlussvorlage“)
Dem Antrag kann nicht stattgegeben werden, da bis zum o. g. Termin vor Erstellung der
Beschlussvorlage keine positive Opinion vorgelegt wurde.
Es wird daher empfohlen, dass der Antragsteller den Antrag dann erneut stellt, wenn absehbar
ist, dass die positive Opinion innerhalb des vorgegebenen Zeitraums vorgelegt werden kann.
Seite 20 von 22 6. Tarlatamab
Tarlatamab ist in der amtlichen ATC-Klassifikation 2026 in der Gruppe „Monoklonale Antikörper
und Antikörper-Wirkstoff-Konjugate“ der ATC-Code L01FX33 zugeteilt. Eine DDD ist nicht
vergeben.
Sachverhalt für das Fertigarzneimittel
IMDYLLTRA
Darreichungsform: Pulver zur Herstellung eines Konzentrats und Lösung zur Herstellung einer
Infusionslösung
Anwendungsgebiete laut Fachinformation/Zusammenfassung der Merkmale: IMDYLLTRA ist
indiziert als Monotherapie zur Behandlung von erwachsenen Patienten mit kleinzelligem
Lungenkarzinom im fortgeschrittenen Stadium (ES-SCLC).
Patientengruppe laut Fachinformation/Zusammenfassung der Merkmale: Erwachsene
Dosierung laut Fachinformation/Zusammenfassung der Merkmale: Das empfohlene
Dosierungsschema von IMDYLLTRA beträgt 1 mg an Tag 1 als Initialdosierung, gefolgt von 10
mg an den Tagen 8 und 15 und anschließend 10 mg alle zwei Wochen.
CHMP Opinion: liegt noch nicht vor
Datum der Erteilung der Zulassung: geplant für Mai 2026
Markteinführung: geplant für Juli 2026
Seite 21 von 22 Aktuell gültige Messzahlen
Berechnung der Messzahlen nach VwV
Unter Berücksichtigung von Anlage 2
- Abschnitt „4.5. Wöchentliche/monatliche oder zyklusabhängige Anwendung“
- Abschnitt „4.8. Initial- und Erhaltungstherapie“
N1= 1x 1 Durchstechflasche à 1 mg Tarlatamab an Tag 1= 1 (Initialtherapie)
N2= 2x 1 Durchstechflasche à 10 mg Tarlatamab innerhalb 4 Wochen (an Tag 8 und 15) = 2
(Erhaltungstherapie)
N3= 6x 1 Durchstechflasche à 10 mg Tarlatamab innerhalb 12 Wochen= 6 (Erhaltungstherapie)
Beantragte Messzahlen durch den Antragsteller
Beantragt wird die Aufnahme der wirkstoffbezogenen Ausnahme „Tarlatamab“ in Abschnitt
„Abgeteilte Darreichungsformen zur Injektion oder Infusion“ unter die Position
Immunsuppressiva/Zytokine“ mit den Messzahlen:
N1 = 1
N2 = 2
N3 = 6
Seite 22 von 22 Entscheidungsempfehlung
Vorbehaltlich der Positive Opinion wird empfohlen, die Position „Tarlatamab“ als
wirkstoffbezogene Ausnahme in Abschnitt „Abgeteilte Darreichungsformen zur Injektion oder
Infusion“ unter die Position Immunsuppressiva/Zytokine“ mit den Messzahlen N1 =1, N2 =2 und
N3 =6 aufzunehmen.
Die finale Fachinformation muss zusammen mit einer schriftlichen Bestätigung des
Antragstellers, dass die SmPC, die dem BfArM bei Antragstellung vorlag, hinsichtlich
der für die Bestimmung der Packungsgrößen maßgeblichen Angaben unverändert
geblieben ist, innerhalb der in der VwV in §4 Satz (7) genannten Frist dem BfArM nachgereicht
werden. Anderenfalls kann der Antrag dann erneut gestellt werden, wenn absehbar ist, dass die
Zulassung innerhalb des vorgegebenen Zeitraums erteilt werden kann.
Begründung
Die vom BfArM ermittelten Messzahlen entsprechen der VwV.
Stellungnahmen zu den Empfehlungen des BfArM:
Im aktuellen Workflow wurden keine Stellungnahmen eingereicht.
Schlussempfehlung des BfArM („Beschlussvorlage“)
Dem Antrag kann nicht stattgegeben werden, da bis zum o. g. Termin vor Erstellung der
Beschlussvorlage keine positive Opinion vorgelegt wurde.
Es wird daher empfohlen, dass der Antragsteller den Antrag dann erneut stellt, wenn absehbar
ist, dass die positive Opinion innerhalb des vorgegebenen Zeitraums vorgelegt werden kann.
1. Budesonid_Kinder
2. Leniolisib
3. Nerandomilast
4. Nirmatrelvir und Ritonavir
5. Remibrutinib
6. Tarlatamab
15.04.2026
Datei
PD
