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.
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.
‘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 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.
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.
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.
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.
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:
These can include:
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:
Examples of indirect harm include:
Examples include:
Examples include:
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:
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:
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:
Both use errors and abnormal use should be documented and handled within a manufacturer’s quality management system.
The manufacturer should consider factors such as the following:
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.
An ‘undesirable side-effect’ is:
An ‘undesirable side-effect’ is not:
When the ‘undesirable side-effect’ is expected by the manufacturer, it should be:
When the ‘undesirable side-effect’ is unexpected, it should be handled like all other incidents.
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.”
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:
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.