On 6 October 2020, the European Commission published guidance on the vigilance system for insulin infusion pumps and integrated meter systems. The European Commission’s intention is to further clarify the requirements of the Directive 93/42 concerning Medical Devices (“MDD”) and MEDDEV 2.12/1 Rev. 8 guidelines of January 2013 on a medical devices vigilance system (“MEDDEV 2.12/1 Rev. 8”) for these specific products.
The guidance only relates to insulin infusion pumps and integrated meter systems (insulin infusion pumps operating in combination with a blood glucose monitoring system). Therefore, continuous glucose monitoring (CGM) devices and associated devices such as infusion sets and/or cartridges fall outside the guidance’s scope. The European Commission provides that future guidance may be developed for these devices.
The guidance aims to serve as a complement to the general requirements provided in the MDD and the MEDDEV 2.12/1 Rev.8. In this regard, the European Commission invites manufacturers to read the guidance in conjunction with the MDD, the MEDDEV 2.12/1 Rev. 8, and the European Commission’s DSVG00 guidance of September 2015 on the introduction to device specific vigilance.
Different categories of incidents to be reported
The guidance provides a table with examples of what must be reported as a device performance problem that caused or contributed to an incident. The table classifies the device performance problems in three sections, depending on the urgency of the report of the incident. The European Commission reminds that this list is not exhaustive, but merely illustrative:
- The first table concerns those events that must be reported on an individual basis, in compliance with the timescales provided in the MEDDEV 2.12/1 Rev. 8. These include clinical and symptomatic incidents such as death, severe hypoglycaemia, or unexpected medical intervention. Other events included in this section are device alarm system problems, pumping problems (without alarm), improper flow or infusion (without alarm), fluid leak impacting dose, and computer system security problems.
- Events provided in the second table can be included in periodic summary reports (PSR). Charging problems, display or visual feedback problems, and fluid leak not impacting dosing are some of the events included in this table. Manufacturers who cannot use PSR are expected to report these events individually.
- The third table refers to events that must be reported at the time the adverse trend is identified. This section includes clinical symptoms not meeting the MEDDEV 2.12/1 Rev. 8 incident reporting criteria that are increasing in the frequency or the severity of events. Other events included in this section are power problems (with alarm), pumping problems (with alarm), and unexpected shutdown (with alarm). Manufacturers may choose to include in their trend reports additional events associated with the same problem which have been reported as incidents, to explain their conclusion that a statistically significant increase has been identified.
Each of the incident categories listed is accompanied by medical device problem codes developed by the International Medical Device Regulators Forum (IMDRF).
Our team regularly assists manufacturers in complying with their vigilance reporting obligations. Please do not hesitate to contact us should you have any question or need support.
Authored by Fabien Roy and Silvia Lopez Arnao