Vigilance Report Review under IVDR and MDR

Reducing Overlap in EU Vigilance Report Reviews to Improve Regulatory Efficiency

Vaida Jukneviciute, Manager, In Vitro Diagnostics, MedTech Europe

Under the European medical devices and in vitro diagnostic medical devices (IVD) regulations (IVDR and MDR), serious incidents must be reported promptly to the relevant competent authorities.

[Download a Practical Guide to Device & IVD Post-Market Surveillance, Vigilance & Reporting]

They assess the reports and oversee manufacturers’ actions to address any identified issues. However, currently, both the Notified Bodies and Competent Authorities are often reviewing single serious incident reports simultaneously, resulting in administrative inefficiencies and increased costs for manufacturers.

According to a recent MedTech Europe position paper, the review of single vigilance reports is the responsibility of the Competent Authorities while the Notified Bodies are primarily responsible for assessing the impact of vigilance data on the certificates they issue. The assessment typically occurs as part of their scheduled (often annual) surveillance audits.

European industry is calling on the European Commission to reassess the current interpretation of MDR and IVDR and to optimise vigilance data review practices.

“Streamlining these processes would help eliminate redundant reviews, allowing regulatory resources to be allocated more effectively and ensuring that oversight efforts remain focused on enhancing patient safety and product quality.”

 For further insights, refer to MedTech Europe’s position paper on Submission of vigilance reports to Notified Bodies under EU MDR & IVDR.

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Vaida Jukneviciute is part of the MedTech Europe Regulatory Affairs team, where she covers the implementation of EU MDR and IVDR, focusing on post-market surveillance and vigilance as well as labelling requirements specific to IVDs. 

She also plays an active role in MedTech Europe's advocacy efforts for both pre-market authorization and post-market requirements for IVDs.