MDCG Vigilance Guidance Updated to Include IVDs

By Amelia Boldrick and Elizabeth Pugh

Background

The Medical Device Coordination Group (MDCG) has issued an update to the European vigilance guidance MDCG 2023-3. The document now covers devices regulated under the IVDR. As Emergo by UL reported last year, the initial version of MDCG 2023-3 explicitly excluded IVDs from its scope.

Guidance on vigilance reporting for IVDs

The guidance now includes IVD-specific examples of incidents, serious incidents, and Field Safety Corrective Actions (FSCAs). Additionally, new questions and responses concerning concepts and terms specific to IVD vigilance were added.

For example, the terms incident and serious incident are now defined in a tabular format for both Regulations. This emphasizes an important component of the definition of incidents under the IVDR: harm as a consequence of an action taken or not taken on the basis of information or results provided by a device. This concept is expanded on further with the addition of Question 8, which addresses indirect harm in incidents involving IVDs. Similarly, Question 9 addresses expected erroneous results. Like expected undesirable side effects, these are subject only to trend reporting when documented in the product information and quantified in the technical documentation.

Other noteworthy changes

Beyond the inclusion of IVDs, the document now features a table of contents with embedded links to each question. There are a few other noteworthy changes applicable to all types of medical devices. Interestingly, impairments leading to diagnosed psychological trauma were removed from the examples included for Criterion B under Question 2 on reporting criteria.

The addition of Question 11 clarifies manufacturer vigilance reporting obligations for CE-marked devices used in clinical investigations and performance studies, as well as for post-market clinical follow-up investigations and performance follow-up studies. Question 19 addresses reporting preventive or corrective actions related to serious incidents and FSCAs versus the inclusion of actions unrelated to safety via the manufacturer’s periodic safety update report or post-market surveillance report.

Finally, the revised guidance references version 7.3.1 of the Manufacturer Incident Report (MIR) template, indicating that an update to the current version 7.2.1 can be expected in the near future.

Concluding remarks

The inclusion of IVDs within the scope of MDCG 2023-3 was an important and necessary update. The guidance is now thematically complete and comprehensively covers vigilance for devices under both Regulations. Emergo by UL now looks forward to the release of the new MIR form and further updates on the progress of the EUDAMED vigilance module.

This update to the vigilance guidance further advances post-market surveillance (PMS) systems. The IMDRF Adverse Event Codes and the mandatory EUDAMED vigilance module are all developments that contribute to PMS.