MDCG 2023-3 Questions and Answers on vigilance terms and

Medical Devices

Medical Device Coordination Group Document MDCG 2023-3

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MDCG 2023-3

Questions and Answers on vigilance terms

and concepts as outlined in the Regulation

(EU) 2017/745 on medical devices

February 2023

This document has been endorsed by the Medical Device Coordination Group (MDCG)

established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of

representatives of all Member States and it is chaired by a representative of the

European Commission.

The document is not a European Commission document and it cannot be regarded as

reflecting the official position of the European Commission. Any views expressed in this

document are not legally binding and only the Court of Justice of the European Union

can give binding interpretations of Union law.

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Introduction

This document aims to clarify important terms and concepts that are outlined in Section 2 of

Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). Establishing a

common understanding of these terms and concepts is necessary for an effective and

harmonised implementation of the vigilance requirements under the MDR.

The document is written for competent authorities, economic operators and other relevant

parties.

Some of the definitions presented in this document are reintroduced from the Guidelines on a

Medical Devices Vigilance System

with, where relevant, modifications for alignment with the

MDR.

The term ‘devices’ will be understood to include medical devices, accessories for medical

devices and products listed in Annex XVI to the MDR.

The document is non-exhaustive and should be read in conjunction with the MDR, relevant

standards

and MDCG guidance documents

Terms and concepts that are outlined in the corresponding articles of the Regulation (EU)

2017/746 on in vitro diagnostic medical devices (IVDR) are outside the scope of this document.

1. What is the difference between an ‘incident’ and a ‘serious incident’ with a device

under the MDR?

The main difference between an ‘incident’ and a ‘serious incident’ under the MDR is the severity

of the related health or public health outcome (or potential outcome) linked to an issue with a

device made available on the market.

An ‘incident’ (Article 2(64) MDR) is any malfunction or deterioration in the characteristics or

performance of a device made available on the market, including use-error due to ergonomic

features, as well as any inadequacy in the information supplied by the manufacturer

and any

undesirable side-effect.

Incidents are not reportable to competent authorities under Article 87(1) MDR. However,

incidents must be documented and considered in the manufacturer’s quality management

system and reported in accordance with requirements outlined in Article 88 MDR.

Guidelines on a Medical Devices Vigilance System, MEDDEV 2/12-1 rev. 8, January 2013.

Please note that the MEDDEV 2.12/1 rev. 8, January 2013 was in operation under the Directives (Directive 93/42/EEC

concerning medical devices (MDD) and Directive 90/385/EEC on the approximation of the laws of the Member States relating to

active implantable medical devices (AIMDD)) and is not applicable under the MDR.

For definition of a ‘standard’ please refer to Article 2(1) Regulation (EU) No 1025/2012 of the European Parliament and of the

Council of 25 October 2012 on European standardisation. A summary list of titles and references of harmonised standards can be

found on the European Commission Medical Devices website:

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

All MDCG Guidance documents can be found on the European Commission Medical Devices website:

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en.

Please note this document is intended to be updated to include the IVDR.

The general requirements regarding the ‘information supplied by the manufacturer’ are outlined in Section 23 of Annex I MDR and

a definition is provided in EN ISO 15223-1:2021. The information supplied by the manufacturer should be regarded as part of the

medical device or accessory. For the purpose of this document, this information includes the label (packaging or marking),

instructions for use, technical description, installation manual, quick reference guide, training material, any promotional material,

sales material and statements by the manufacturer and other information accompanying the device (accompanying information).

Trend reports (Article 88 MDR) should be reported to the competent authority(ies) of the Member State(s) in which the incidents

occurred.

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A ‘serious incident’ (Article 2(65) MDR) is an incident as outlined in Article 2(64) MDR that has

in addition, either led to or has the potential to lead to the significant health or public health

outcomes outlined in Article 2(65)(a) to (c) MDR. More specifically, serious incidents are the

subset of incidents that directly or indirectly led, might have led or might lead to the death or the

temporary or permanent serious deterioration in the state of health of a patient, user or other

person or posed a serious public health threat.

The manufacturer must report serious incidents in accordance with Article 87(1) to (5) MDR to

the relevant competent authority.

Reportability under the MDR

If an incident is determined on first evaluation not to be a serious incident, it must nonetheless

be investigated whether it might lead to/might have led to one of the outcomes specified in

Article 2(65)(a) to (c) MDR, if the circumstances were less fortunate (for instance without the

performance of an intervention by a third party or if there was exposure of more vulnerable

patients to the same situation, etc.).

If the manufacturer cannot exclude that the incident could potentially have led to the outcomes

specified in Article 2(65)(a) to (c) MDR, the incident must be considered serious and reported to

the relevant competent authority.

If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about

whether the incident is reportable, it must nevertheless submit a report within the timeframe

required in accordance with Article 87(2) to (5) MDR.

Flowchart 1 below illustrates the process to be followed by manufacturers for the management

of incidents and serious incidents.

In this context, the relevant competent authority is the competent authority of the Member State in which the serious incident

occurred. Serious incidents are to be reported to the competent authorities by means of the Manufacturer Incident Report (MIR),

which became applicable from 1

January 2020. The MIR can be found on the European Commission Medical Devices website:

https://ec.europa.eu/docsroom/documents/41681.

Once Eudamed is fully functional, reports of serious incidents, will be automatically transmitted to the notified body that issued the

certificate (Article 56 MDR) for the device in question (Article 92(9) MDR). In the interim, manufacturers and notified bodies are

advised to agree on how that information is provided to the notified body that issued the certificate for the device in question and

may continue with the same procedures used under the Directives (MDD and AIMDD).

Article 87(7) MDR.

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Manufacturer receives vigilance information e.g. a complaint*:

 From a healthcare professional, patient or user about a

suspected incident related to a device,

 via a competent authority,

 from an economic operator e.g. the authorised

representative, importer or distributor,

 in the course of its own routine monitoring activities, e.g. its

post-market surveillance, post-market clinical follow-up

(possible sources: literature searches, registry data,

questionnaires, etc.)

Does the complaint fulfil the

criteria of an incident under

Article 2(64) MDR ?

Yes

Does the incident fulfil the criteria of a

serious incident under

Article 2(65) MDR ?

The manufacturer must report in

accordance with Article 87(1) MDR to the relevant

competent authority within the timelines outlined in

Article 87(3) to (5) MDR

as follows

The manufacturer does not have to report in

accordance with Article 87(1) MDR.

The manufacturer must comply with the

requirements for trend reporting in accordance with

Article 88 MDR.

The manufacturer does not

have to report to the competent

authority but must record the complaint

in its quality

management system.

Any serious incident:

must be reported

immediately after

causal relationship is

established/causal

relationship is reasonably

possible between the

device and serious

incident and

no later than 15 days

(calendar days)

A serious public health

threat:

must be reported

immediately after the

manufacturer becomes

aware of the threat and

no later than 2 days

(calendar days)

To be considered:

Is the complaint related

to an issue with the

device?

Is the issue with the

device one of the

following:

- a malfunction or

deterioration in its

characteristic or

performance,

- an inadequacy in the

information supplied by

the manufacturer,

- an undesirable side-

effect.

To be considered:

Are the basic reporting

criteria outlined in

question 2 of this

document fulfilled?

Is it an expected

undesirable side-

effect** ?

The timelines for reporting must be considered as

calendar days, each beginning at the date of the

manufacturers awareness of the potentially serious

incident (= day 0). The reporting period begins on the

day after the date of the manufacturers awareness

of the potentially serious incident (= day 1).

See question 11 and 12 for clarification on the

reporting timelines and manufacturer awareness

date.

Death or an unanticipated

serious deterioration in a

person's state of health

must be reported

immediately after

established/suspected

causal relationship

between the device and

serious incident and

no later than 10 days

(calendar days)

Yes

* A complaint is defined in EN ISO 13485:2016 and can be described as a written, electronic or oral communication

that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a

medical device or related to a service that affects the performance of such medical devices. It is important to note that

complaints and information relevant for vigilance reporting are not only externally generated but can also be created

due to the manufacturers own activities for routine monitoring of a devices safety and performance.

** Expected undesirable side-effects are clearly documented in the product information and quantified in the technical

documentation and subject to trend reporting pursuant to Article 88 MDR (see question 8 for elaboration of

undesirable side-effects).

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2. What are the basic reporting criteria for a serious incident?

Any incident which meets all three basic reporting criteria A – C listed below is considered a

serious incident and must be reported to the relevant competent authority:

A. an incident (Article 2(64) MDR) has occurred, and

B. the incident directly or indirectly led, might have led or might lead to any of the outcomes of

a serious incident (Article 2(65) MDR), and

C. a causal relationship between the serious incident and the manufacturer's device has been

established, is reasonably possible or suspected.

Elaboration of the reporting criteria A - C is provided below

Criterion A: an incident has occurred

Examples of an incident can include:

 a malfunction or deterioration in the characteristics or performance of the device, e.g. a

device that fails or is losing its ability to achieve its intended purpose (Article 2(12) MDR)

when used as indicated in the information supplied by the manufacturer (see question 4 for

further clarification of a malfunction or deterioration in the characteristics or performance a

device),

 a deterioration in the characteristics of the device that is related to manufacturing errors,

e.g. sterilisation process failures,

 a use error due to ergonomic features, e.g. a use error caused by a mismatch between the

user interface

and the physical or medical condition of the intended user (see question 7

for further clarification of use-error due to ergonomic features),

 any inadequacy in the information supplied by the manufacturer, e.g. insufficient

information on how to maintain, adjust or calibrate the device in the instructions for use

that can lead to a use error,

 unclear instructions in the labelling or the manufacturer’s instructions for use, e.g. the

information is not written in a way that is suitable for/readily understood by the intended

user,

 undesirable side-effects e.g. allergic skin reactions such as allergy to nickel or wound

therapies (see question 8 for further clarification of undesirable side-effects).

Criterion B: the incident directly or indirectly led, might have led or might lead to any of

the outcomes of a serious incident

For this criterion to be fulfilled, it is sufficient that an incident associated with the device

happened and the incident was such that, if it occurred again, it might have led or might lead to

any of the following outcomes:

 death of a patient, user or other person,

 the temporary or permanent serious deterioration of a patient's, user's or other person's

state of health,*

 a serious public health threat.**

According to EN 62366-1:2015, the ‘user interface’ is the means by which the user and the device interact.

The user interface covers all the elements of the medical device with which the user interacts, including the physical aspects of the

device as well as visual, auditory, tactile displays and is not limited to the software interface. For the purpose of this document, the

information supplied by the manufacturer such as the accompanying information is considered part of the device and its user

interface.

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* A serious deterioration in state of health of a patient, user or other person can

include:

I. a life-threatening illness or injury,

II. permanent or temporary impairment of a body structure or a body function

(including impairments leading to diagnosed psychological trauma),

III. a condition necessitating hospitalisation or prolongation of existing

hospitalisation,

IV. medical or surgical intervention to prevent I or II, examples of this can be:

 professional medical care or additional unplanned medical treatment,

 a clinically relevant increase in the duration of a surgical procedure

V. a chronic disease,

VI. foetal distress, foetal death or any congenital abnormality (including congenital

physical or mental impairment) or birth defects.

Please note that any indirect harm that may occur as a consequence of the medical

decision or action taken/not taken on the basis of information or result(s) provided by a

device can also lead to serious incidents, including a serious deterioration in the state of

health of a patient, user or other person (see question 3 for clarification of indirect harm).

** A serious public health threat (Article 2(66) MDR) is an event 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.

These events would include:

I. the possibility of multiple deaths occurring at short intervals,

II. events that are of significant and unexpected nature such that they become

alarming as a potential public health hazard.

Examples of serious public health threats can be the following (non-exhaustive list):

 contagious illnesses, such as human immunodeficiency virus (HIV),

Creutzfeldt-Jakob Disease (CJD), Ebola, Zika virus, severe acute

respiratory syndrome (SARS), Coronavirus disease (COVID-19),

 events involving high risk of exposure to a disease (e.g. cancer) after

use of a medical device, which affects a significant number of the

population, or a specific patient population (diabetics, cardiac patients,

etc.) or a vulnerable population (children, pregnant women, etc.),

 exposure to toxic compounds with a potentially negative/harmful effect

on humans,

 widespread distribution of falsified or incorrectly labelled devices

leading to multiple serious incidents, e.g. distribution of non-sterile

devices labelled as sterile,

 cyberattack related to life supporting or life-saving devices.

A serious threat to public health will in principle not be limited to one isolated case or

individual patient issue, and identifying these events may depend on signal detection or

trending of multiple events of the same nature/typology, same root cause, etc.

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Criterion C: causal relationship between the serious incident and the manufacturer's

device has been established or is reasonably possible or suspected

The manufacturer has to investigate if there is a causal relationship between the serious

incident and their device or if such a causal relationship is reasonably possible, i.e. the device

cannot reasonably be excluded as a contributory cause of the serious incident.

In assessing the link between their device and the serious incident, the manufacturer should

take account of factors such as:

 clinical or medical plausibility,

 the opinion of healthcare professionals,

 the results of the manufacturer’s own preliminary assessment,

 known information provided in the technical documentation and evidence of previous

similar serious incidents,

 other relevant evidence held by the manufacturer.

Establishing or identifying the link between the manufacturer’s device and the serious incident

may be difficult, especially when there are multiple devices and drugs involved. In complex

situations, it should be assumed that the device may have or potentially could have contributed

to the serious incident, and the manufacturer should therefore be cautious in its evaluation and

conclusions. In case of doubt, the manufacturer must nevertheless submit the report referred to

in Article 87(1) MDR.

3. How can incidents indirectly lead to a serious deterioration of health?

In a number of cases, the device may, due to its intended use, not directly(or instantly) lead to

physical injury or damage to a person’s health but lead to indirect harm.

Indirect harm may occur as a consequence of the medical decision, action taken or lack of such

on the basis of information or result(s) provided by the device or as a consequence of a

treatment. Indirect harm, due to an incident that meets or has the potential to meet the

outcomes of a serious incident must be reported in accordance with Article 87(1) to (5) MDR.

Examples of indirect harm may include:

 a misdiagnosis,



a delayed diagnosis,



delayed treatment,



inappropriate treatment,



absence of treatment,



transfusion of inappropriate materials.

Article 87(7) MDR.

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4. With reference to Article 2(64) MDR, what is meant by a ‘malfunction or deterioration

in the characteristics or performance of a device’?

A ‘malfunction

or deterioration

in the characteristics or performance of a device’ can be

described as a situation where a device fails to achieve, or is unable to uphold, the performance

(Article 2(22) MDR) intended by the manufacturer when used in accordance with the information

supplied with the device.

Examples of device malfunctions may include the following:

 a device that due to a sudden software error fails to make correct assessments and

provides an incorrect treatment (dosage) to the patient,

 electrical short circuit causing the device to catch fire or stop working,

 premature battery depletion e.g. a malfunction resulting in high current drain depleting

the device battery faster than indicated in the instructions for use,

 a device that breaks during use although it was used/handled in accordance with the

instructions for use.

Examples of deteriorations in the characteristics or performance of a device may include the

following:

 a gradual occlusion of fluid or gas path, change in resistance to flow or electrical

conductivity of a device as a result of ageing or repeated use,

 a sensor drift caused by physical changes, e.g. a gradual decrease in accuracy on a

sensor caused by physical changes such as airborne pollutants (dust, chemicals, vapor

and other contaminants),

 UV degradation of a device e.g. cracking or disintegration of device materials due to

ultraviolet radiation, such as sunlight exposure,

 elasticity changes (increase or decrease), e.g. of compression stockings that due to an

elasticity increase are not suitable for their intended use anymore,

 failure of a device component or other types of significant loss of electrical, material or

mechanical integrity of a device due to wear or fatigue.

The manufacturer should always conduct a root cause investigation when a device, used in

accordance with information supplied by the manufacturer itself, fails to achieve or uphold its

performance.

5. Who is considered as the ‘user’ of a device?

For the purpose of this document, the ‘user’ (Article 2(37) MDR) is any healthcare institution,

healthcare professional or lay person (e.g. caregiver, patient) who uses the device, or persons

installing or maintaining the device. The user of a device can also be referenced as the

operator, e.g. in standards.

See also the following definition of a ‘malfunction’ provided in EN ISO 14155:2020: ‘a malfunction is a failure of a device to

perform in accordance with its intended purpose when used in accordance with the manufacturer’s instructions for use or to meet its

performance specifications’.

For the purpose of this document, the following definition of deterioration was taken into account: ‘the action or process of a

device becoming impaired or inferior in quality, function or condition’ (Merriam-Webster.com Dictionary, Merriam-Webster,

https://www.merriam-webster.com/dictionary/deterioration).

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6. What is a ‘use error’ in comparison to ‘abnormal use’?

A ‘use error’ is when the user’s action or lack thereof while using the device leads to a different

result or outcome than that expected by the user or intended by the manufacturer.

Use errors can be caused by a user’s failure to pay attention, memory lapses or mistakes during

device use, or lack of understanding or knowledge in relation to device use. Such use errors do

not fall within the definition of an incident. However, use errors that are caused by the

ergonomic features of a device qualify as incidents and in case of serious incidents reportable

under Article 87(1) MDR (see question 7 for elaboration).

Use errors must nevertheless be documented and handled within the manufacturer’s quality

management system.

‘Abnormal use’ is the deliberate violation of the intended use of a device. It is a deliberate act or

omission of an act by the user that is counter to or violates normal use of a device, and is

beyond any further reasonable means of interface-related risk control by the manufacturer.

An example of abnormal use may include off-label use of a device such as a doctor that, based

on a medical decision, uses a device for a different indication than indicated in the

manufacturer’s instructions for use.

Abnormal use of a device, must be documented and handled within the manufacturer’s quality

management system.

7. What is a ‘use-error due to ergonomic features’ as mentioned in Article 2(64) MDR?

‘Use-error due to ergonomic features’ can be described as use errors caused by device features

that were designed to allow the device to be easily, effectively and safely used by the intended

user.

Ergonomic features can be described as the physical features of a device that are designed to

facilitate and ensure that the interaction between the user and the device is safe, effective and

efficient. The ergonomic features of the device includes components such as measurement and

monitoring features, display scales, alarms, software menu and any other factor related to the

user interface.

Use errors due to ergonomic features may be caused by a mismatch between the device

features (including the information provided in the instructions for use) and factors such as the

user profile

and/or the environment in which the device is intended to be used.

It should be noted that in some cases, use errors caused by ergonomic features may not be

immediately identified and can lead to serious outcomes due to the unintentional nature of the

According to EN ISO 14971:2019 and EN 62366-1:2015, use errors include the inability of the user to complete their task when

using the device (Note 1, 3.52, EN ISO 14971:2019). Furthermore, according to the EN ISO 14971:2019 the occurrence of an

unexpected physiological response of the patient when using the device is not by itself considered a use error (note 4, 3.52, EN ISO

14971:2019) and a malfunction of a device that leads to an unexpected result, is also not considered a use error (note 5,3.52, EN

ISO 14971:2019).

Based on data, e.g. from complaints, related to abnormal use, manufacturers might be able to identify possible systematic misuse

or off-label use of their device, and verify that the device’s intended purpose is appropriate and, where relevant, identify the need for

initiating a field safety corrective action.

According to EN 62366-1:2015/AMD1, the user profile can include ‘the mental, physical and demographic traits of an intended

user group, as well as any special characteristics, such as occupational skills, job requirements and working conditions, which can

have a bearing on design decisions related to the device’.

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error and the potential that the user is not aware of its occurrence. This note is especially

important for devices where the patient is responsible for installing or adjusting their treatment

e.g. drug-delivery devices or devices with a diagnostic or measuring function.

Use errors due to ergonomic features must in the case of a serious incident, be reported in

accordance with Article 87(1) to (5) MDR or in case of incidents reported in accordance with

Article 88 MDR.

8. What is an ‘undesirable side-effect’ and how is it reported within the vigilance

system?

An ‘undesirable side-effect’ under the MDR should be understood as any unintended and

unwanted medical manifestation in the human body, as a consequence of the normal use of a

device.

Undesirable side-effects are not the result of a malfunction, deterioration in the

device’s characteristics or performance, or an inadequacy in the information supplied by the

manufacturer.

An unsuccessful treatment (or treatment failure) should not be considered an undesirable side

effect.

For the purpose of this guidance, undesirable side-effects can be expected or unexpected and

are considered as incidents under the MDR (Article 2(64) MDR).

Expected undesirable side-effects must be clearly documented in the product information, and

quantified in the manufacturer’s technical documentation. They must also be acceptable when

weighed against the evaluated benefits to the patient and/or user arising from the achieved

performance of the device during normal conditions of use (Section 8 of Annex I MDR).

Expected undesirable side-effects must be reported in accordance with the requirements for

trend reporting pursuant to Article 88 MDR.

If the manufacturer cannot demonstrate that a potentially serious incident is an expected

undesirable side-effect within the deadlines set out in Article 87(3) to (5) MDR, it must submit a

Manufacturer Incident report (MIR) within the reporting timelines.

Unexpected undesirable side-effects are not considered in the manufacturer’s risk analysis,

quantified in the manufacturer’s technical documentation or documented in the product

information. If they occur, they are to be handled like all incidents. That means that, if they

qualify as serious incidents within the meaning of Article 2(65) MDR, such side-effects must be

reported in accordance with Article 87(1) MDR as individual serious incident reports (i.e.

individual MIRs).

9. Article 87(5) MDR outlines the timelines for manufacturers to report an unanticipated

serious deterioration in a person's state of health. When is a serious deterioration in

a person's state of health considered ‘unanticipated’?

A serious deterioration in a person's state of health, is considered ‘unanticipated’ if the condition

leading to the deterioration was not considered in the manufacturer’s risk analysis.

A serious deterioration in a person’s state of health is anticipated if it was considered in the

manufacturer’s risk analysis and documented in the risk management report.

It should be noted that the terms ‘undesirable side-effects’ and ‘side-effects’ are used synonymously in the MDR.

In addition to footnote 17, note also for reporting purposes that; ‘identified side-effects, expected side-effects expected

undesirable side-effects and unknown side-effects’ as mentioned in the MDR should all be understood as ‘undesirable side-effects’

and fall under the definition of an incident (Article 2(64) MDR).

In this context, reference to ‘patient’ should be understood as the individual patient i.e. acceptable in terms of the individual patient

benefit.

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For a serious deterioration in the state of health, the manufacturer must ensure there is:

 documented evidence that a risk analysis was used to eliminate or reduce the risk

related to these events as far as possible, or

 the risk is included in the information supplied by the manufacturer to the user, e.g. in

the instructions for use.

10. With reference to the timelines for the reporting requirements outlined in Article 87

MDR, what is meant by ‘immediately’ and ‘without undue delay’?

For the purpose of this document, ‘immediately’ and ‘without undue delay’ should both be

understood as without any delay that is intentionally or negligently caused by the manufacturer.

As a general rule, the report outlined in Article 87(1) MDR must be provided without any delay

or any delay that the manufacturer cannot justify and no later than the timelines outlined in

Article 87(2) to (5) MDR.

To ensure timely reporting, the manufacturer can submit an initial MIR which can be followed by

a follow-up report (Article 87(6) MDR).

Question 11 of this document provides more clarification on how to apply the reporting timelines

outlined in Article 87(3) to (5) MDR.

11. How to apply the reporting timelines defined by Article 87(3) to (5) MDR?

In accordance with the MDR, the reporting referred to in Article 87(1) MDR must take account of

the severity of the serious incident.

The timelines for reporting serious incidents must be considered as calendar days meaning the

reporting periods include weekdays, public holidays, Saturdays and Sundays

As a general rule, the reporting period begins on the day after the awareness date of a

potentially serious incident

at 0:0:1 AM

he awareness date (day=0) refers to the date when

the manufacturer is first made aware or receives information of the occurrence of the

(potentially) serious incident and not after it has conducted its investigation. See also

question

12 for elaboration of the manufacturer awareness date.

The reporting timelines outlined in the MDR are the following:

 any serious incident, that did not involve a death or an unanticipated serious

deterioration in a person's state of health, must be reported immediately after a causal

relationship between device and the serious incident has been established or is

Article 3(3) Regulation (EEC, EURATOM) NO 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods,

dates and time limits, OJ L 124, 8.6.1971, p. 1. For the calculation of the period, Articles 3(4) and (5) of Regulation (EEC,

EURATOM) NO 1182/71 needs to be considered, which state: ”Where the last day of a period expressed otherwise than in hours is

a public holiday, Sunday or Saturday, the period shall end with the expiry of the last hour of the following working day” (Article 3(5))

and ”Any period of two days or more shall include at least two working days” (Article 3(4) of that Regulation).

See Article 3(1), second subparagraph Regulation (EEC, EURATOM) NO 1182/71: “Where a period expressed in days, […] is to

be calculated from the moment at which an event occurs […], the day during which that event occurs […] shall not be considered as

falling within the period in question.”

Article 3(2) (b) Regulation (EEC, EURATOM) NO 1182/71:”beginning of the first hour of the first day”.

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reasonably possible and no later than 15 days after the awareness date of the serious

incident (Article 87(3) MDR),

 a serious public health threat must be reported immediately, and not later than 2 days

after the manufacturer becomes aware of that threat (Article 87(4) MDR),

 death or an unanticipated serious deterioration in a person's state of health must be

reported immediately after a causal relationship between the device and the serious

incident is established or as soon as such relationship is suspected, and no later than

10 days after the awareness date of the serious incident (Article 87(5) MDR).

In the exceptional cases where a manufacturer initially determines that an incident does not

meet the reporting requirements of a serious incident, and then some time later obtains new

information that impacts or changes the initial reportability assessment, which results in the

reporting requirements of a serious incident being met, the period of reporting in this case

begins on the date on which the manufacturer received the information that determined that the

incident is reportable (Article 2(65) MDR).

In both situations i.e., the general rule and the exceptional case, the period ends on the 15th,

2nd or 10th day thereafter (more specifically at 11:59:59 PM

). However, if this (last) day is a

public holiday, Saturday or Sunday the deadline is moved to the following working day

automatically

. Nevertheless, in line with Article 87(3), (4) and (5) MDR requirement to report

’immediately’ but not later than the period provided for in those provisions, it is highly

recommended for the manufacturer to report immediately or as early as possible in time.

A delay in submitting an initial report e.g. due to incomplete information provided by the

healthcare facility, end user or other relevant parties, is not deemed justified. As outlined in

Article 87(6) MDR, the manufacturer can submit an initial MIR followed up by a follow-up report

providing additional information related to the (potentially) serious incident and progress on the

incident investigation(s). Any report must not be unduly delayed because of incomplete

information.

The example below demonstrates the timelines for the exceptional case described above, in

which the manufacturer is first made aware of an incident, and concludes that it does not meet

the reporting requirements of a serious incident, and later obtains new information that impacts

or changes the manufacturer’s previous determination regarding the need to report.

Example

A manufacturer receives a complaint on 1st June 2022. The manufacturer determines that the

criteria of a serious incident were not met and therefore, does not submit a MIR to the relevant

competent authority.

The manufacturer subsequently receives additional information on 1st July 2022. Upon review

of this information, the manufacturer determines that the complaint is a serious incident. The

manufacturer must submit a MIR at the latest by 16th of July 2022.

Variation of the above example:

Article 3(2) (b) Regulation (EEC, EURATOM) NO 1182/71:“expiry of the last hour of the last day”.

See Article 3(4), first subparagraph Regulation (EEC, EURATOM) NO 1182/71: “Where the last day of a period expressed

otherwise than in hours is a public holiday, Sunday or Saturday, the period shall end with the expiry of the last hour of the following

working day.”

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On 2nd July 2022, the manufacturer was made aware that the patient died on 2nd July 2022.

Since the consequence of the serious incident is now a patient death, a report must be

submitted no later than 10 days after awareness date of the serious incident. Therefore, a MIR

must be submitted at the latest by 12th July 2022. In conclusion, it is the earliest date of

reporting which should be considered.

12. With reference to the reporting timelines of a serious incident pursuant to Article 87

MDR, what is considered as the ‘manufacturer awareness date’?

For the purpose of this document, 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 potentially serious incident

. If the handling of these incidents is

performed by the authorised representative or if the manufacturer has outsourced its complaint

and incident handling activities to another natural or legal person (e.g. a subcontractor), then

reference to ’manufacturer’s organisation’ in the context of awareness date will also apply to this

organisation.

In the exceptional cases, where a manufacturer initially determines that an incident does not

meet the reporting requirements of a serious incident and then later obtains new information

that impacts or changes the manufacturer’s previous determination regarding the need to

report, the serious incident must be reported to the relevant competent authority and indicated

in the MIR. In the MIR, the manufacturer should provide the relevant dates in the following two

fields:

 1.2.c. ‘Manufacturer awareness date’

(in this field, the manufacturer should insert the initial awareness date of the

incident).



Section 5

‘General comments’

(in this field, the manufacturer should insert the date in which it received the

information that determined that the incident is reportable (the ‘Manufacturer

awareness date of reportability))

Within the general comments in Section 5 of the MIR, the manufacturer should also explain the

difference between the two dates (the manufacturer awareness date and awareness date of

reportability).

It should be noted that if the manufacturer is uncertain about whether the incident is a serious

incident, it must nevertheless submit a MIR within the timelines laid down in Article 87(2) to (5)

MDR.

An example is provided below to demonstrate how to correctly apply the awareness date in the

MIR in the exceptional cases (described above) that a MIR was initially not submitted to the

relevant competent authority as the requirements for reporting a serious incident were not met.

However, upon receipt of subsequent information that the criteria for a serious incident reporting

was met, a MIR was submitted to the relevant competent authority.

Please note that it is intended to update version 7.2.1 of the MIR to include a field for 'Manufacturer awareness date of

reportability’. Until the publication of the updated MIR, manufacturers should include this information in Section 5 'General

comments' instead.

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Example

A manufacturer receives a complaint on 1st July 2022. The manufacturer determines that the

requirements for a serious incident are not fulfilled and does not submit a MIR to the relevant

competent authority.

The manufacturer subsequently receives additional information on 1st August 2022 and upon

review of this information, the manufacturer determines that the complaint is a serious incident.

The manufacturer should then submit a MIR within timelines outlined under the applicable

sections of the MDR, i.e. immediately and not later than 15, 2 and 10 days (Article 87(3) to (5)

MDR), from (the day after) 1st August 2022. In the MIR, the manufacturer should insert the

dates as follows:



1.2.c. Manufacturer awareness date: 1st July 2022.



Section 5 General comments: 1st August 2022 and an explanation

of the difference between the two dates.

13. Why does the MIR in section 1.2(d) have a report type named ‘Final (Non-reportable

incident)’ and when can it be used?

The report type ‘Final, (Non-reportable incident)’ is included under section 1. 2(d) in the MIR for

cases in which the manufacturer has submitted a MIR to the relevant competent authority, but

establishes through its investigation that the criteria for a serious incident (Article 87(1) MDR)

were not met.

The report type ‘Final (Non-reportable incident)’, must be used in the cases below.

 According to Article 87(7) MDR, in case of uncertainty, the manufacturer is obliged to

report a potentially serious incident within the timelines outlined in Article 87(3) to (5)

MDR. However, it is possible that the manufacturer, within this timeframe, is unable to

establish whether the reporting requirements outlined in Article 87(1)(a) MDR are

fulfilled. After submitting a MIR to the relevant competent authority, further root cause

investigation of the device in question (after the reporting timelines) could clarify that the

requirements of a serious incident were not fulfilled and the case was not reportable.

 Cases in which the manufacturer’s analysis of additional information, received after it

has submitted a MIR to the relevant competent authority, reveals that the reporting

requirements of Article 87(1) MDR were not fulfilled.

In the abovementioned cases, the manufacturer can select the box ‘Final (Non-reportable

incident)’ under section 1.2 (d) of the MIR and provide a rationale for its conclusion in section

4.2(b).

It should be noted that the report type ‘Final (Non-reportable incident)’ may also be used for

cases where the manufacturer has received a report of a potentially serious incident from the

competent authorities (Article 87(11) MDR) but establishes within the timelines outlined in

Article 87(3) to (5) MDR that the requirements of a serious incident are not fulfilled. In such

cases, the manufacturer can submit a final MIR selecting the report type ‘Final (Non-reportable

incident)’ and provide a rationale for its conclusion in section 4.2(b).

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If the manufacturer has not finalised its root cause analysis or established the cause and/or

contributing factors, the case cannot be considered to qualify as non-reportable. In such cases,

a MIR with the report type ‘Final (Non-reportable) incident’ should not be submitted to the

relevant competent authority.

14. What is a ‘field safety corrective action’?

A ‘field safety corrective action (FSCA)’ (Article 2(68) MDR) is a corrective action taken by a

manufacturer for technical or medical reasons to either prevent or reduce the risk of a serious

incident, which is associated with a device that is made available on the market.

A FSCA may include:

 the return of a device to the supplier or a recall

 a device exchange,

 a device modification,

 retrofit by purchaser of manufacturer’s modification or design change,

 a device destruction,

 advice given by manufacturer regarding the use of the device, such as additional

information on maintenance, cleaning instructions, and training and/or the follow-up of

patients, users or others,

 recommended inspections/examination by device user (e.g. regular professional checks

of proper functioning in a testing setting),

 changes of software/firmware in the device, including device update (e.g. version

rollback).

It should be noted that advice given by a manufacturer may include modifications to the clinical

management of patients to address a risk of death or a serious deterioration in the state of

health related specifically to the characteristics of a device. An example of this can be cases

involving implantable devices where it is often clinically unjustifiable to explant the device.

Therefore, special patient follow-up or treatment, irrespective of whether any affected un-

implanted devices remain available for return, constitutes measures to be included in a FSCA.

A FSCA must be communicated/transmitted without undue delay for the attention of users or

customers of the device in question through a field safety notice (FSN) (Article 2(69) MDR) sent

by the manufacturer.

Unless duly justified by the situation of the individual Member State (e.g. a translation error in

the instructions for use that appears only in certain languages and therefore affects only specific

countries), the content of the FSN must be consistent in all Member States. The FSN must be

edited in an official Union language or languages determined by the Member State in which the

FSCA is taken.

The MDR requirements for the content of the FSN are outlined in paragraph 2 of Article 89(8)

MDR.

Example of a FSCA conducted by a manufacturer:

As part of its post-market surveillance activities, the manufacturer identifies a systematic device

malfunction.

Removals from the market for purely commercial non-safety related reasons are not included.

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If the affected devices are available on the market and they have or potentially could lead to a

serious incident, the manufacturer must initiate a FSCA to either prevent or reduce the risk of

such incidents.

The FSCA implemented by the manufacturer may include permanent or temporary changes to

the device’s labelling or instructions for use or a recall of all affected devices that are available

on the market.

The manufacturer must without delay inform the relevant competent authority(ies) in the

Member State(s) in which the FSCA has been or is to be undertaken. Furthermore, the

manufacturer must also, ensure that information about the FSCA is brought without delay to the

attention of the affected users by means of a FSN.

15. With reference to Article 87(1)(b) MDR, what is meant with ‘..including any field

safety corrective action undertaken in a third country…’?

For FSCAs undertaken in a third country, where the device is also legally made available on the

Union market,

all relevant competent authorities must be notified unless the reason for the

FSCA is limited to devices made available in the third country.

Example

An example of such a FSCA would be where a recall of a device has taken place in a third

country due to a malfunction with certain lots. If the lots affected by this recall have also been

made available on the Union market, then all relevant competent authorities must be notified of

the FSCA.

16. Within the scope of Article 89 MDR on analysis of serious incidents and field safety

corrective actions, what is an ‘evaluating competent authority’?

The ‘evaluating competent authority’ is the national competent authority of the Member State

responsible for the assessment of the risks arising from reported serious incidents that occur

within its territory, and/or of the adequacy of FSCAs envisaged or undertaken, within its territory,

by the manufacturer (Article 89(2) and (3) MDR)

In the scenarios provided below, the evaluating competent authority is:

 For serious incidents: the competent authority of the Member State in which the

serious incident occurred.

 For FSCA(s): the competent authority(ies) of the Member State(s) in which the FSCA is

being or is to be undertaken, e.g. Member States in which the devices affected by the

FSCA are made available.

The competent authority in the Member State in which the manufacturer or its authorised

representative has its registered place of business must always be informed of the

FSCA, even if it is not amongst the Member States in which the FSCA is being or is to

be undertaken.

The ’Union market’ refers to the territories of the European Union Member States, and due to the European Economic Area (EEA)

is extended to Norway, Lichtenstein and Iceland, and via the Customs Union Agreement to Türkiye. For Türkiye, please see also the

‘Notice to stakeholders EU-Turkey Customs Union Agreement in the field of medical devices’ on the Commission website.

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In the context of commenting on the content of the draft FSN as outlined in paragraph 1

of Article 89(8) MDR, manufacturers must, except in cases of urgency, submit the draft

FSN, to the evaluating competent authority to allow it to review and make comments

(Article 89(8) MDR).

In the cases referred to in 89(9) MDR, the draft FSN must be

submitted to the designated coordinating competent authority.

In all cases, the final FSN must be transmitted to all evaluating competent authorities.

 In the cases referred to in Article 89(9) MDR, the evaluating competent authorities can

actively participate in a procedure with the aim of coordinating the assessments referred

to in Article 89(3) MDR. Unless otherwise agreed between the competent authorities

participating in the coordinated procedure, the coordinating competent authority must be

the competent authority of the Member State in which the manufacturer or its authorised

representative has its registered place of business. Once designated, the coordinating

competent authority must through Eudamed or alternative means inform the

manufacturer, the other competent authorities and the Commission that it has assumed

this role.

17. Where can I find information on vigilance reporting in Eudamed?

Eudamed is the new European database on medical devices, which will centralise all relevant

information on devices which have been placed on the Union market. The database is defined

and described in Article 33 MDR and the specific requirements related to vigilance are outlined

in Article 92 MDR.

Until Eudamed becomes fully functional, competent authorities, economic operators and other

relevant parties should follow the ‘MDCG 2021-1 Guidance on harmonised administrative

practices and alternative technical solutions until EUDAMED is fully functional’, which has been

endorsed by the Medical Device Coordination Group (MDCG).

The MDCG guidance details alternative temporary solutions for implementing certain MDR

provisions related to Eudamed and on exchange of information to enable Member States and

other relevant parties to meet their obligations under the MDR until the full functionality of the

database.

Information of how to act and alternative mechanisms to be used to exchange data in case of

technical unavailability or malfunction of Eudamed after it is fully functional, can be found in the

‘COMMISSION IMPLEMENTING REGULATION (EU) 2021/2078 of 26 November 2021 laying

down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of

the Council as regards the European Database on Medical Devices (Eudamed)’.

The manufacturer should allow 48 working hours for receipt of comment on the FSN unless the nature of the FSCA dictates a

shorter timescale e.g. for a serious public health threat.

Until Eudamed is fully functional, alternative means provided in the following guidance are applicable:

https://health.ec.europa.eu/system/files/2021-05/2021-1_guidance-administrative-practices_en_0.pdf

OJ L 426, 29.11.2021, p. 9–15, link: https://eur-lex.europa.eu/eli/reg_impl/2021/2078

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18. In accordance with Articles 10, 13 and 14 MDR, manufacturers, importers and

distributors are required to inform competent authorities of devices that present or

are considered to present a serious risk. What is meant by a ‘serious risk’?

For the purpose of this document, a ‘serious risk’ is defined as a situation where a serious harm

resulting from the use of a device that might affect patients, users or the public is likely to

happen

. A serious risk may include situations where the effects of the risk are not immediate.

For cases involving a device that presents a serious risk, the manufacturer, importer or

distributor must immediately inform the competent authorities of the Member States in which

they made the device available and, where applicable, the notified body that issued a certificate

for the device in accordance with Article 56 MDR.

19. What is a ‘Periodic Summary Report’?

A ‘Periodic summary report’ (PSR) is an alternative reporting regime by which the manufacturer,

in agreement with the respective national competent authority that is coordinating the periodic

summary reporting (and in consultation with the competent authorities referred to in Article 92(8)

(a) MDR), can report similar serious incidents with the same device or device type in a

consolidated way. Criteria for periodic summary reporting include situations where; the root

cause has been identified, a FSCA has been implemented or where the serious incidents are

common and well documented.

The requirements for periodic summary reporting are outlined in Article 87(9) MDR.

20. What are the criteria for a ‘common and well documented’ serious incident?

A ‘common and well documented serious incident’ as referenced in Article 87(9) MDR, must be

clearly identified in the manufacturer’s risk analysis and should have led to incident reports,

which have been assessed by the manufacturer and the relevant competent authority. The

serious incident and the root cause should be clinically well-known (i.e. a certain qualitative or

quantitative predictability is established) by the manufacturer.

See also Article 2(23) MDR for definition of a ‘risk’.

For information on the reporting obligations of importers and distributors, including for devices presenting a serious risk see also

MDCG 2021-27 - Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Link:

https://ec.europa.eu/health/system/files/2021-12/mdcg_2021-27_en.pdf