Guidance on the vigilance system for CE-marked devices and the Device Specific Vigilance Guidance (DSVG) Template

This newsletter is aimed toward introducing the Device Specific Vigilance Guidance (DSVG), a pivotal document aimed at harmonsing vigilance reporting and offering comprehensive guidance for manufacturers of Specific Devices. This guidance is designed to provide clarity on vigilance reporting of Specific Devices to the relevant Competent Authority and should be considered alongside the requirements of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). It’s important to note that the DSVG neither replaces nor extends the existing regulatory requirements.

Key Reporting Obligations

Manufacturers are responsible for evaluating each event individually to ensure compliance with the statutory reporting requirements outlined in the MDR and IVDR. The guidance specifies:

• Individual Serious Incident Reporting:

Manufacturers must report serious incidents to the relevant Competent Authority within specified timeframes.

• Periodic Summary Reporting (PSR):

An alternative regime allowing manufacturers to report similar serious incidents involving the same device or device type in a consolidated manner.

• Trend Reporting:

Manufacturers are required to report any statistically significant increase in the frequency or severity of incidents that could impact the benefit-risk analysis.

For illustrative purposes, the guidance includes examples of device-related problems that should be reported as incidents or serious incidents. This list is not exhaustive but serves as a guide for manufacturers, and can be found in the guidance.

Clinical References and Guidelines and IMDRF Terminologies

Manufacturers may use clinical references or current clinical guidelines for Specific Devices as a resource for identifying potential incident examples and complications. The guidance highlights the importance of using the most recent version of the IMDRF adverse event code for categorising adverse event reporting, with examples provided for both medical device problems and health effects.

Conclusion

The DSVG provides essential guidance for manufacturers on the vigilance reporting of Specific Devices, emphasising the importance of compliance with the MDR and IVDR requirements. By adhering to these guidelines, manufacturers can ensure they are fulfilling their reporting obligations, ultimately contributing to the safety and efficacy of medical devices on the market.

For more information and to stay updated on the latest guidance, manufacturers are encouraged to refer to the official documents and websites related to the MDR and IVDR regulations.