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.
MDCG Vigilance Guidance Updated to Include IVDs
MDCG Vigilance Guidance Updated to Include IVDs
The Medical Device Coordination Group (MDCG) has issued an update to the European vigilance guidance MDCG 2023-3.
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