The MDCG released a new guidance document on vigilance terms and concepts under the EU MDR 2017/745. It is available: HERE

Highlights from the document are provided below. Please review the full guidance for all questions and complete answers.

What is meant by ‘immediately’ and ‘without undue delay’?

‘Immediately’ and ‘without undue delay’ should both be understood as without any delay that is intentionally or negligently caused by the manufacturer.

When does the ‘clock start’ on reporting timelines?

As a general rule, the reporting period begins on the day after the awareness date of a potentially serious incident. Per the 24-hour clock, the next day starts at 00:00:01.

The awareness date is day=0.

NOTE: the reporting deadlines are calendar days. This means the reporting deadlines include public holidays and weekend days. Therefore, where the last day of the deadline falls on a public holiday or on the weekend, the deadline is considered to be the last hour of the following workday.

What is considered the ‘manufacturer awareness date’?

The ‘manufacturer awareness date’ is the date when the first employee or representative of the manufacturer’s organization, receives information (e.g., a complaint) regarding the potentially serious incident.

What is the purpose of the report type ‘Final (Non-reportable incident)’?

The report type ‘Final, (Non-reportable incident)’ is for situations where the manufacturer has submitted an incident report but then later establishes that the criteria for a serious incident were not met.

This report type is needed because manufacturers should, in cases of doubt, report. It may then be determined later, while investigating the incident, that it did not meet the requirement to be reported. In this situation, the manufacturer can select the ‘Final, (Non-reportable incident)’ and provide its conclusion under this section.

Which Competent Authorities must be notified of serious incidents and field safety corrective actions (FSCAs)?

Serious incidents: the competent authority of the Member State in which the serious incident occurred.

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. Plus, the competent authority where the manufacturer, or its authorized representative, is located must also be notified, even if was not directly impacted by the FSCA.

What is the difference between an ‘incident’ and a ‘serious incident’ that must be reported?

While all incidents should be documented and investigated, not all incidents are reportable. So, what makes an incident serious enough to warrant reporting?

The main difference is the severity of the related health or public health outcome (or potential outcome) linked to an issue. An incident is considered serious, and therefore reportable, under the following circumstances:

• • If the incident 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.
  • If the manufacturer cannot exclude that the incident could potentially have led to a) the death of a patient, user, or other person, b) the temporary or permanent serious deterioration of a patient’s, user’s, or other person’s state of health, or c) a serious public health threat.
  • If the manufacturer is uncertain about whether it is reportable, it should err on the side of reporting within the timeframes.

Examples of a ‘temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health’

These can include:

• • a life-threatening illness or injury,
  • permanent or temporary impairment of a body structure or a body function (including impairments leading to diagnosed psychological trauma),
  • a condition necessitating hospitalization or prolongation of existing hospitalization,
  • 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
  • a chronic disease,
  • fetal distress, fetal death, or any congenital abnormality (including congenital physical or mental impairment) or birth defects.

Examples of a ‘serious public health threat’

A serious public health threat includes the possibility of multiple deaths occurring at short intervals or events that are of significant and unexpected nature such that they become alarming as a potential public health hazard.

Examples include:

• • 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 a high risk of exposure to a disease (e.g., cancer) after the 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 labeled devices leading to multiple serious incidents, e.g., distribution of non-sterile devices labeled as sterile,
  • Cyberattacks related to life-supporting or life-saving devices.

How can an incident indirectly lead to a serious deterioration of health?

Examples of indirect harm include:

• • a misdiagnosis
  • a delayed diagnosis
  • delayed treatment
  • inappropriate treatment
  • absence of treatment
  • transfusion of inappropriate materials

Examples of device malfunctions

Examples include:

• • 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 deterioration in the characteristics and/or performance of a device

Examples include:

• • a gradual occlusion of fluid or gas path, change in resistance to flow or electrical conductivity of a device as a result of aging 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

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.

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.

What is a ‘use error’ versus ‘abnormal use’ of a device?

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.

Examples include:

• • user’s failure to pay attention
  • memory lapses or mistakes during device use

Use errors are generally not considered incidents unless it was caused by the ergonomic features of the device.

Abnormal use is the deliberate violation (act or omission of an act) of the intended use of a device.

For example:

• • 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

Both use errors and abnormal use should be documented and handled within a manufacturer’s quality management system.

How to determine if there is a causal relationship between the serious incident and the manufacturer’s device.

The manufacturer should consider factors such as the following:

• • 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

Where the incident is complex (such as where multiple devices and/or drugs were involved), and therefore the causal link is more challenging to identify, the manufacturer should assume that the device may have, or potentially could have, contributed to the serious incident and report it.

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

An ‘undesirable side-effect’ is:

• • any unintended and unwanted medical manifestation in the human body, as a consequence of the normal use of a device
  • both expected and unexpected
  • considered an incident

An ‘undesirable side-effect’ is not:

• • the result of a malfunction, deterioration in the device’s characteristics or performance
  • an inadequacy in the information supplied by the manufacturer
  • An unsuccessful treatment (or treatment failure)

When the ‘undesirable side-effect’ is expected by the manufacturer, it should be:

• • clearly documented in the product information
  • quantified in the manufacturer’s technical documentation
  • 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
  • assessed as part of the manufacturer’s trend reporting requirements under MDR Art. 88

When the ‘undesirable side-effect’ is unexpected, it should be handled like all other incidents.

Example of when a field safety corrective action (FSCA) ‘undertaken in a third country’ must be reported in Europe.

The MDCG document cites the following:

“…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.”

What is a ‘Periodic Summary Report’?

A ‘Periodic summary report’ (PSR) is an alternative reporting process. This allows a manufacturer, in agreement with the respective national competent authority that is coordinating the periodic summary reporting, to report similar serious incidents with the same device or device type, in a consolidated way.

A manufacturer may be eligible for Periodic Summary Reporting when:

• • the root cause has been identified
  • an FSCA has been implemented
  • where the serious incidents are ‘common and well documented’

A ‘common and well documented serious incident’ 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.