Riccardo Chiarini -

The MDCG 2024-1Guidance on the vigilance system for CE-marked devices document, recently endorsed by the Medical Device Coordination Group, brings forth significant updates to the vigilance system for CE-marked medical devices.

Aimed at harmonizing vigilance reporting, the guidance offers a detailed framework for manufacturers on how to report individual serious incidents, implement periodic summary reporting, and understand the nuances of trend reporting. The guidance emphasizes the importance of reporting any serious incidents to the relevant Competent Authority. It also outlines the option to report similar serious incidents involving the same device or device type within the context of a Periodic Summary Report. Additionally, the guidance covers Trend Reporting of any statistically significant increase in the frequency or severity of incidents that are not serious incidents or expected undesirable side effects. With its emphasis on detailed incident reporting and the utilization of IMDRF terminologies for categorized adverse event reporting, MDCG 2024-1 represents a pivotal step towards enhancing the regulatory oversight of medical devices within the EU.

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