On November 11, 2024, the European Medical Device Coordination Group (MDCG) issued an update to the Questions and Answers on vigilance MDCG 2023-3, which includes a comprehensive update concerning the scope of in vitro diagnostic medical devices (IVDs) regulated under the IVDR 2017/746.
The revised guidelines of MDCG 2023-3, which include the IVDR, cover the following content.:
(1) The definition of “Incident” and “Serious Incident” under the IVDR are as follows:
- Incident (Article 2(67) IVDR) refers to any malfunction or deterioration in the characteristics or performance of a device placed on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device.
- Serious Incident (Article 2(68) IVDR) refers to any incident that directly or indirectly led, might have led or might lead to any of the following:
(a) the death of a patient, user or other person,
(b) the temporary or permanent serious deterioration of a patient’s user’s of other person’s state of health,
(c) a serious public health threat (as defined in Article 2(69) IVDR.
(2) In the event of an incident, the manufacturer must report to the competent authority within the specified timelines, depending on the type of incident, if the incident directly or indirectly led to, or could have led to, or might lead to a serious incident, and if a casual relationship between the serious incident and the manufacturer’s device has been established, is reasonably possible, or is suspected.
(a) All Serious Incidents:
- If a causal relationship between the medical device and the incident has been established, is reasonably possible, or is suspected, the manufacturer must report the incident without delay, but no later than 15 days.
(b) Serious Public Health Threat:
- If the manufacturer becomes aware of a public health threat, the manufacturer must report the incident immediately, but no later than 2 days.
(c) Death or Unexpected Serious Health Deterioration:
- If a causal relationship between the medical device and the serious incident is confirmed or suspected, the manufacturer must report the incident immediately, but no later than 10 days.
(3) Newly Added Question on Vigilance Related to MDR and IVDR (Q8, Q9, Q11, Q19)
Q8. What is considered ‘any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device’s as outlined in Article 2(67) IVDR? How is it reported within the IVDR vigilance system?
- This includes harm that indirectly occurs to the patient when a healthcare professional makes an incorrect medical decision based on inaccurate results provided by an IVD.
- Since this type of harm does not meet the criteria for a serious incident, it should be reported in accordance with the reporting requirements outlined in IVDR Article 83, as part of trend reporting.
Q9. What is an ‘expected erroneous result’ and how is it reported within the IVDR vigilance system?
- Erroneous results refer to any incorrect (inadequate or inaccurate) results or information provided by an IVD
- Anticipated erroneous results must be reported in accordance with the trend reporting requirements outlined in Article 83 IVDR.
- if such incidents are considered serious incidents under Article 2(68) IVDR, they must be reported as individual serious incident reports (i.e. as individual Manufacturer Incident Reports (MIRs)) in accordance with Article 82(1) IVDR.
Q11. Is it required to report serious incidents with CE-marked devices used in a clinical investigation or performance study?
- CE-marked MD/IVDs used in clinical investigation or performance studies are subject to vigilance reporting requirements.
- Serious incidents related to these devices must be reported in accordance with Article 87(1) MDR and Article 82(1) IVDR.
Q19. Should manufacturers inform competent authorities of preventive or corrective actions in accordance with Article 83(4) MDR and Article 78(4) IVDR?
- If the manufacturer identifies the need for preventive and corrective actions related to a serious incident or field safety corrective action (FSCA), the manufacturer must report this information to the competent authorities.
- This information should be provided using the relevant vigilance reports (MIR or FSCA forms).
- Information on preventive and corrective actions may also be provided to the competent authorities through periodic safety update reports (PSUR) or post-market surveillance reports (PMSR).
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