Regulatory Affairs Updates
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MDCG 2023-3 Rev 1 released
- Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager
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.
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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.Â
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