A new revision of the Medical Device Coordination Group (MDCG) guidance document 2023-3 has been published in November 2024, focusing on questions and answers related to vigilance terms and concepts outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). This revision, MDCG 2023-3 Rev.1, includes several important updates and changes:
Key Updates
- Expanded Scope: The document now incorporates references to both MDR and IVDR throughout, aligning it with Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
- New Questions: Several new questions have been added, including:
- Indirect harm related to IVDs
- Expected erroneous results
- Reporting serious incidents with CE-marked devices used in clinical investigations or performance studies
- Preventive and corrective actions
- Clarified Definitions: The document provides clearer distinctions between "incidents" and "serious incidents" for both medical devices and in vitro diagnostic medical devices.
- Updated Reporting Criteria: The guidance offers revised criteria for reporting serious incidents, including new examples specific to IVDs.
- Manufacturer Awareness: The document clarifies the concept of "manufacturer awareness date" in relation to reporting timelines.
Significant Changes
- IVD-Specific Content: Many sections now include examples and explanations specific to in vitro diagnostic medical devices.
- Flowchart Revision: The flowchart for determining reportable incidents has been updated to include relevant terms and definitions from the IVDR.
- Use Errors: The guidance provides more detailed explanations of use errors, including those due to ergonomic features.
- Field Safety Corrective Actions: The document expands on the definition and reporting requirements for field safety corrective actions.
- Eudamed Usage: The guidance includes updated information on when Eudamed can be used for vigilance reporting.
- Serious Public Health Threat: New examples of what constitutes a serious public health threat have been added.
Implications
This revised guidance document aims to provide clearer and more comprehensive information on vigilance reporting under both MDR and especially IVDR. It addresses the specific needs of in vitro diagnostic medical devices while maintaining consistency with medical device regulations. The updates should help manufacturers, competent authorities, and other stakeholders better understand and comply with vigilance requirements in the EU medical device regulatory framework.
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