---
title: "Update manual on borderline classification IVDR and MDR published"
description: "On 12 September 2025, a new manual on borderline classification IVDR and MDR was published. The revision includes clarifications for borderline cases, including red blood cell additive solutions containing adenine, dual action creams with menthol and capsaicin, lactose tablets for vaginal use, microabrasion dental stain removers, medical examination table covers, and mobile sterile air systems. Other examples remain unchanged. Manufacturers and regulatory teams can use the updated manual to confirm the correct qualification and classification of their products, supporting compliance decisions and avoiding potential regulatory disputes."
url: https://qbdgroup.com/en/regulatory-updates/update-manual-on-borderline-classification-ivdr-and-mdr
type: "Regulatory update"
language: en
published: 2025-09-30
author: "Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"Update manual on borderline classification IVDR and MDR published\", https://qbdgroup.com/en/regulatory-updates/update-manual-on-borderline-classification-ivdr-and-mdr"
---
# Update manual on borderline classification IVDR and MDR published
> On 12 September 2025, a new manual on borderline classification IVDR and MDR was published. The revision includes clarifications for borderline cases, including red blood cell additive solutions containing adenine, dual action creams with menthol and capsaicin, lactose tablets for vaginal use, microabrasion dental stain removers, medical examination table covers, and mobile sterile air systems. Other examples remain unchanged. Manufacturers and regulatory teams can use the updated manual to confirm the correct qualification and classification of their products, supporting compliance decisions and avoiding potential regulatory disputes.

The revision includes clarifications for borderline cases, including red blood cell additive solutions containing adenine, dual action creams with menthol and capsaicin, lactose tablets for vaginal use, microabrasion dental stain removers, medical examination table covers, and mobile sterile air systems. Other examples remain unchanged.

## What does this mean for you?

Manufacturers and regulatory teams can use the updated manual to confirm the correct qualification and classification of their products, supporting compliance decisions and avoiding potential regulatory disputes.

[![CTA RA update MD](https://no-cache.hubspot.com/cta/default/7030766/interactive-185449024004.png)](https://qbdgroup.com/hs/cta/wi/redirect?encryptedPayload=AVxigLI1gRJjxW3BLYcRYs3hT%2F%2BoXK7JkqvcwywksWoqh8VFHqdVQb8meGqdiInvHcZevd1JmkliTnQhqLIoN7QYbR%2BqbrhY5k7Y1j5Tvfmfkf%2Bduyh%2F7pwA2Y4GzzixMdfoSdK7Gwr08Ti%2BFAEo3SRNd%2FokrfWUlvE3PoHI%2BNJl5a6owlI2Lh6JLC1uEiWtUkvebz8K8SULxKmA%2BEynEGPKqDkdDg%3D%3D&webInteractiveContentId=185449024004&portalId=7030766)
---
Source: https://qbdgroup.com/en/regulatory-updates/update-manual-on-borderline-classification-ivdr-and-mdr — © QbD Group. Quote freely with attribution and a link back.