Today the MDCG released vigilance-related guidance. Below are the links to each new document:
The purpose of MDCG 2024-1 is to harmonize vigilance reporting, particularly for the above specific devices. The guidances provide examples of what could be submitted under each reporting mechanism:
Serious incidents must be reported to the relevant Competent Authority. The reporting timeframe depends on the severity of the incident.
MDCG 2024-1 provides a (non-exhaustive) list of examples, of serious incidents that would be individually reported. For example, from MDCG 2024-1-1, cardiac ablation devices:
The examples reference the IMDRF’s ‘Adverse Event Reporting’ (AER) documents: ‘Medical Device Reporting’ (Annex A) and ‘Health Effects – Clinical Signs and Symptoms or Conditions’ (Annex E).
Periodic Summary Reports are a mechanism for manufacturers to consolidate reporting, when they have similar serious incidents with the same device/device type. This prevents having to report each serious incident individually.
To qualify for Periodic Summary Reporting:
Further, the format, content, and frequency of reporting must be agreed upon with the Competent Authority. Until EUDAMED is functional, manufacturers should continue to use the current PSR Form. Note that “the additional information required under the MDR may be added to the general comments section of the form“.
MDCG 2024-1 provides a (non-exhaustive) list of examples regarding what can be included under a PSR. For example, from MDCG 2024-1-3, cardiac implantable electronic devices and their leads (CIEDs):
The examples reference the IMDRF’s ‘Adverse Event Reporting’ (AER) documents: ‘Medical Device Reporting’ (Annex A) and ‘Health Effects – Clinical Signs and Symptoms or Conditions’ (Annex E).
Manufacturers are required to proactively report if there is a statistically significant increase in the:
MDCG 2024-1 provides a (non-exhaustive) list of examples regarding which trends should be reported. For example, from MDCG 2024-1-2, coronary stents and associated delivery systems:
The examples reference the IMDRF’s ‘Adverse Event Reporting’ (AER) documents: ‘Medical Device Reporting’ (Annex A) and ‘Health Effects – Clinical Signs and Symptoms or Conditions’ (Annex E).
You may be interested in these additional resources: