Mandatory Use of EUDAMED Vigilance Module Delayed Until 2028

By Amelia Boldrick and Elizabeth Pugh

On Oct. 22, 2026, the European Commission (EC) informed stakeholder interest groups through its Communication and Information Resource Centre for Administrations, Businesses and Citizens web platform that mandatory use of the European Database on Medical Devices (EUDAMED) Vigilance and Post-Market Surveillance (VGL) module will not occur before 2028. 

VGL module delay follows functional audit

The announcement comes after unspecified challenges were identified during the initial functional audit of the VGL module. Successful completion of this audit was required before a notice declaring the module functional could be published in the Official Journal of the European Union by the end of 2026. Publication of the notice would have started the official six-month countdown for mandatory use. The EC now expects to add functionality and implement fixes. VGL Competent Authority Board testing in the EUDAMED Playground, which was planned for the third quarter of 2026, has been postponed to early 2027 to better coordinate the efforts of those assisting with testing. 

Another functional audit is planned

While mandatory use was last forecast for the second quarter of 2027, the EC indicated that another functional audit of the VGL module will be required. No additional details were provided. Further work in 2027 is expected to include addressing issues identified during the 2026 audit and conducting additional testing.

Connection with the UDI/Devices module

Once the VGL module becomes mandatory, manufacturers of devices that were taken off the market prior to the dates of application of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) but that may still be in the field will need to complete a simplified registration form in EUDAMED for vigilance reporting purposes. The delay in mandatory use of the VGL module also delays simplified EUDAMED registration for these devices. 

A parallel U.S. delay: AEMS has not yet replaced MAUDE

Production deployment to consolidate U.S. Food and Drug Administration (FDA) electronic Medical Device Reports (eMDRs) in the Adverse Event Monitoring System (AEMS) took place on July 27, 2026; however, adverse event reports continue to be accessible to the public only via the Manufacturer and User Facility Device Experience (MAUDE) database. Despite the self-described “aggressive schedule” announced in March, which initially estimated replacing MAUDE with the real-time AEMS system by May 2026, adverse event reports continue to flow into the platform with a roughly one-month delay. 

MAUDE connections with other FDA databases

MAUDE data connects to a number of other FDA databases that are key to post-market surveillance, such as the Product Code Classification and Total Product Life Cycle (TPLC) databases. It is unknown whether or how the AEMS system interacts with these databases or whether complete retirement of MAUDE is feasible given the current TPLC system architecture.

Concluding remarks

Emergo by UL continues to monitor these developments and will provide updates on the EUDAMED VGL module and the replacement of the FDA MAUDE database as new information becomes available.