MHRA Adds Two New UK Approved Bodies: LNE-GMED UK Limited & Scarlet NB UK Ltd
30 January 2024
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2 February 2024Today the MDCG released vigilance-related guidance. Below are the links to each new document:
Overview
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 that should be reported individually,
- serious incidents consolidated within a Periodic Summary Report, or
- non-serious incidents submitted in a trend report.
Serious Incidents
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 Reporting (PSR)
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:
- the root cause must have been identified,
- an FSCA has been implemented, or
- the serious incidents are common and well documented.
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).
Trend reporting
Manufacturers are required to proactively report if there is a statistically significant increase in the:
- frequency or severity of non-serious incidents, or
- expected undesirable side-effects that could have a significant impact on the device’s benefit-risk analysis.
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).
Further Reading
You may be interested in these additional resources:
