Vigilance on Medical Devices: Update of MDCG Guidelines 2023-3 Rev.2
Vigilance on Medical Devices is a key activity to ensure patient safety, as set out in the MDR (EU) 2017/745 and IVDR (EU) 2017/746.
The MDCG Guidelines 2023-3, published in its first version in November 2024, is an essential reference to clarify all aspects necessary to achieve regulatory compliance with medical device vigilance managing procedures and incident reporting.
The second update of MDCG Guidelines 2023-3 Rev.2 was published in January 2025. The previous version of the guideline dates back to October 2024.
Highlights of MDCG-2023 on Medical Device Vigilance
- Distinction between accident and serious accident: The guidelines clarify the distinction between accident and serious accident, as defined in Article 2(64) of the MDR. An accident is any malfunction or deterioration in the characteristics or performance of a device placed on the market, including errors in use due to ergonomic characteristics, as well as any inadequacy in the information provided by the manufacturer and any undesired effects. Serious incidents include events that directly or indirectly caused, may have caused or are likely to cause death, serious deterioration of health (temporary or permanent) or pose a significant threat to public health.
- Timing of reporting: manufacturers must report serious incidents to regulatory authorities within 15 days of knowledge of the event unless they pose a threat to public health or involve deaths or unexpected serious deterioration.
- Distinction between intended use and misuse: The guidelines provide guidance on how to distinguish between intended use and misuse, with implications for risk assessment.
- Trend reports: manufacturers must submit trend reports to the competent authorities to monitor incidents and trends over time.
- Role of economic operators with specific reporting and monitoring obligations.
- Complaint analysis: a flow chart illustrates the process of analysing complaints to determine the need for reporting to the regulatory authorities under MDR.
Revisions of MDCG Guidelines 2023-3
The MDCG revision 2023-3 Rev.1 of October 2024 included in vitro diagnostic Medical Devices (IVDs) and specific examples of incidents and corrective actions. The MDCG 2023-3 Rev.2 update of January 2025 clarified certain aspects to align with the gradual roll-out of Eudamed, the European database that also collects and manages medical device vigilance data, as stipulated in Regulation (EU) 2024/1860.
Footnote 8 has been updated to specify that when the Eudamed Post-Market Surveillance and Supervision module becomes mandatory, Notified Bodies will have access to the supervision reports. Until then, it is recommended that manufacturers and Notified Bodies agree on a method to share this information and to continue to apply the procedures in the Directives (MDD, AIMDD and IVDR).
Furthermore, in question 21, the term ‘Eudamed vigilance (VGL) module’ was changed to ‘Eudamed Postmarket surveillance and Vigilance module (VGL module)’.
Finally, it was clarified that the review period of a draft Field Safety Notice (FSN) by a competent authority is 48 hours (2 working days) unless urgent corrective action is required.
Although these changes are limited in scope, they emphasise the importance of centralising information on incidents, fostering greater transparency and enabling competent authorities to intervene in good time to mitigate risks to patients.
Implications for Manufacturers
Medical Device vigilance requires manufacturers to adopt standardised operating procedures for incident reporting and post-market monitoring. The updating of technical documentation, including PMS Reports and PSUR is essential to ensure compliance.
The MDCG Guidelines 2023-3 Rev.2 is a further step towards clearer and more consistent regulation of the supervision of Medical Devices in the European Union.
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02/18/2025
