Vigilance Under the EU MDR: A glossary
Many medical device manufacturers are in the habit of using the terms post-market surveillance and vigilance interchangeably. However, while medical device post-market surveillance is entirely focused on establishing processes that can ensure the compliance of medical devices and in vitro diagnostic medical devices, vigilance is concerned with reporting severe adverse incidents and FSCAs, also known as Field safety corrective actions, to the relevant authorities.
Any severe incident involving a medical device marketed and sold in the European Union and any field safety corrective action performed in the EU or other markets for devices that are also sold in the EU must be reported to the European Medicines Agency through EUDAMED.
Please note that “serious incident” and “adverse event” are used interchangeably in this article.
Vigilance for medical devices: The basics
Vigilance is described in Section 2, Articles 87-92 of the European Medical Device Regulation (MDR, 2017/745) and Section 2, Articles 82-87 of the In Vitro Diagnostics Regulation (IVDR, 2017/746). There are no significant differences between the two regulations in terms of vigilance, so for the purposes of this article, we will only mention the medical device vigilance system described in the MDR – however, you can assume the same is valid for any devices covered under the IVDR. The MDR vigilance section covers Class I, Class IIa, and IIb, Class III, and implantable medical devices.
Medical device vigilance is the identification, reporting, and trending of serious incidents or FSCAs involving a medical device to the competent regulatory authority.
Why do we need vigilance for medical devices?
In order to protect the patient’s health and safety, and healthcare professionals, medical device vigilance systems are developed and designed to reduce the chances of medical devices causing harm to patients and healthcare professionals. It plays a substantial role in assessing risks associated with medical devices and the post-market surveillance of these devices in the European Union and practically everywhere else in the world.
Serious incidents
A serious incident is defined in the vigilance section of the MDR as;
“…any incident that directly or indirectly led, might have led or might lead to:
- the death of a patient, user, or other person
- the temporary or permanent serious deterioration of a patients’, users’, or other persons’ state of health
- a serious public health threat”
Serious deterioration of health means any life-threatening illness or serious injury, permanent impairment, hospitalization or prolonged hospitalization, or medical or surgical intervention to avoid any of these.
In summary, any adverse event involving a medical device that hurts a patient or user to a serious degree or could potentially have hurt a patient or user must be reported to the competent authority in as little as two days, depending on the type of incident.
Field safety corrective action (FSCA)
FSCAs are defined as;
“… corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.”
FSCAs are vital to any medical device vigilance system and must be treated as such.
FSCAs should be reported to the competent authority for any action taken within the EU and outside of the EU for devices that are also marketed and sold in the EU.
Trend reporting
Trend reporting is not distinctly defined in the vigilance part of MDR but covers any statistically significant increases in frequency or severity of incidents that involve medical devices or in vitro diagnostic medical devices.
A statistical increase in frequency or severity rate is established compared to the expected or previously seen rates for both the device in question and similar devices on the market.
Trend reporting is a new vigilance requirement for medical devices found in Article 83 of the EU IVDR and Article 88 of the EU MDR.
It is important to note that trend reporting must use appropriate statistical methods.
Reporting timelines
The timelines for reporting an incident involving a medical device depend on the severity of the incident and the threat to public health:
- Serious incidents should be reported no later than 15 days after the manufacturer has become aware of the incident
- Serious incidents involving death or a serious deterioration in a person’s health should be reported no later than ten days after the manufacturer has become aware of the incident
- Serious public health threats should be reported no later than two days after the manufacturer has become aware of the threat
Please note that the (voluntary) reports must be submitted after the manufacturer has been made aware of the incident, not immediately after the event has occurred.
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