Skip to main content
Consultations ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Consultation on specific IVD related GMDN terms

By November 19, 2021November 26th, 2021No Comments

The GMDN Agency have provided the summary information below. This is regarding a consultation on specific IVD related GMDN terms.

The IVD Team at the GMDN Agency have launched a consultation regarding a proposed scaling back of antibody-specific IVD terms within the GMDN. The move would be to consolidate all infectious disease antibody-class specific terms for a particular analyte to a single concept, including total antibody and neutralizing antibody concepts.

This means the distinction between IgA, IgM, and IgG and any combination thereof would be removed, leaving a broader single concept. We hope this change will make the identification of the correct GMDN Term easier with less opportunity for mis-assignment.

The consultation is open until the 29 of November 2021 at 16:00hrs GMT.

What do I need to do?

Please provide feedback by 25 November 2021 to Ashleigh Batchen, BIVDA will then provide a response to the GMDN on member’s behalf.