MDCG 2023-3 Rev. 1: Guidance for vigilance requirements for medical devices and IVDs

The document MDCG 2023-3 Rev. 1 of November 2024 provides a comprehensive explanation of important terms and concepts in the area of vigilance for medical devices and in vitro diagnostic medical devices in accordance with EU regulations 2017/745 (MDR) and 2017/746 (IVDR). It is aimed at competent authorities, economic operators and other relevant parties to ensure uniform implementation of the vigilance requirements set out in MDR Art. 87 and IVDR Art. 82 and 83.

The MDCG 2023-3 Rev. 1 Guideline provides clarifications on the vigilance requirements of EU MDR and IVDR regulations, in particular on the identification and reporting of serious incidents and on the implementation of security corrective measures in the field.

Distinction of incidents

A central aspect is the distinction between “incident” and “serious incident.” While an incident includes any malfunction or deterioration in the characteristics or performance of a product, the subset of serious incidents is defined by its potential or actual serious consequences for individual or public health. The document defines the reporting obligation by manufacturers and the criteria for serious incidents and explains the decision-making process using a flow chart with the respective deadlines of immediate (day 0) to 15 calendar days.

Definitions

Terms such as “malfunction”, “deterioration of properties or performance”, “usage error” compared to “abnormal use” or “application failure due to ergonomic features” (see MDR Art. 2 and IVDR Art. 2) are defined and exemplified. Reporting deadlines for various types of serious incidents depend on the distinction between, for example, immediate threat to public health, death or unexpected serious deterioration of health status.

Specific aspects of in vitro diagnostics and clinical investigations

Specific aspects of in vitro diagnostic medical devices are also addressed, such as expected faulty results and indirect damage caused by medical decisions based on IVD results. Incidents of CE-marked IVDs must also be reported as part of clinical investigations or performance studies. In addition, topics such as safety corrective actions in the field, the role of the evaluating competent authority and the use of EUDAMED for vigilance reporting are described, and explanations of terms such as “serious risk”, “periodic summary report” and criteria for “frequent and well-documented” serious incidents are provided.

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Source and detailed information: https://health. ec. europa.eu/document/download/af1433fd-ed64-4c53-abc7- 612a7f16f976_en?filename=mdcg_2023 -3_en.pdf (delete space for link)

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