Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On November 11th, 2024, the Medical Device Coordination Group (MDCG) released its first revision (MDCG 2023-3 Rev 1) of the questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746. MDCG 2023-3 provides a clearer framework for key terms and concepts essential to implementing the vigilance requirements under EU Regulations (MDR 2017/745 and IVDR 2017/746). Aimed at competent authorities, economic operators, and other stakeholders, the document harmonizes definitions for effective regulatory compliance.
Some key takeaways from the revised MDCG
The updated MDCG 2023-3 guidance expands its scope to include the IVDR, alongside general clarifications to support stakeholders in implementing vigilance requirements.
Some key updates include:
- Enhanced Definitions: A new table clearly distinguishes ‘incident’ and ‘serious incident’ under both the MDR and IVDR.
- Flowchart Update: The decision-making flowchart has been revised to explicitly reference both regulations.
- Targeted Examples: Examples specific to IVDR have been added, alongside new cases applicable to both MDR and IVDR.
- Additional Questions: New questions have been included to address practical considerations across both regulatory frameworks.
These updates aim to ensure consistent interpretation and effective application of vigilance requirements under the MDR and IVDR.
What does it mean to you?
This new revision is key for Medical Device and IVD manufacturers to ensure your vigilance procedures are aligned with the updated definitions and examples. In addition the revision is useful for economic operators and other stakeholders to familiarize themselves with the updated guidance to remain compliant, especially when reporting incidents or conducting post-market surveillance.
关于作者
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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