MDCG aims to harmonize adverse events reports for surgical mesh in the EU

The Medical Device Coordination Group (MDCG) wants to harmonize adverse events reporting for surgical mesh implants across EU member states. Over the past decade, there have been reports of adverse events associated with the use of surgical mesh to treat pelvic organ prolapse and stress urinary incontinence, which in some cases have led to serious injury or death.

On June 11, MDCG published a Device Specific Vigilance Guidance (DSVG) on harmonized reporting to Competent Authorities (CA) for urogynaecological surgical mesh implants to treat pelvic organ prolapse and stress urinary incontinence. It details how manufacturers should report adverse events associated with the products to comply with the EU Medical Device Regulation (MDR) and emphasizes that the guidance does not replace or extend any of the vigilance reporting requirements already outlined in the MDR.

"It is the manufacturer’s responsibility to judge each event on its own merit and to ensure compliance with the statutory reporting requirements contained within the MDR," said MDCG.

The guidance provides an overview of handling different reports, including individual serious incidents, periodic summary reports, and trend reports. It references circumstances when the different types of reports are warranted under MDR and how they should be presented. For instance, manufacturers are expected to send individual serious reports to CAs even in cases where there is ambiguity over whether the issue is reportable or when they may need more time to clarify the incident's root cause. On the other hand, manufacturers can agree to file periodic summary reports with their respective CAs.

"This is possible when similar serious incidents involving the same specific device or device type occur and for which the root cause has been identified or a field safety corrective action has been implemented or where the serious incidents are common and well documented," said MDCG. "The format, content and frequency of periodic summary reports should be agreed with the Coordinating Competent Authority (in consultation with the Competent Authorities participating in the Periodic Summary Reporting)."

The group also said that periodic summary reports should follow its guidance on harmonized administrative practices and alternative technical solutions until the European database on medical devices (EUDAMED) is fully operational.

The guidance states that manufacturers are responsible for keeping an eye out for any statistically significant increases in the frequency or severity of incidences that could affect the product's risk-benefit profile and reporting them to their respective CAs.

“Clinical references or current clinical guidelines for Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence may be used by manufacturers in order to identify incident examples and complications,” the guidance states. “Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence manufacturers may refer to relevant local clinical guidelines when identifying incident examples and complications.”

It also includes several examples of how the different reports should be filed and a link to terminologies used by the International Medical Device Regulators Forum (IMDRF) that can be used when reporting adverse events.

MDCG guidance

MDCG aims to harmonize adverse events reports for surgical mesh in the EU

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