Changed Product Labeling

Updated product information related to MDCG 2024-11

The Medical Device Coordination Group (MDCG) has published the guide document MDCG 2024-11, which clarifies which products fall under the scope of the In Vitro Diagnostic Regulation (IVDR, EU 2017/746).

The guidance explains that certain products intended for general laboratory use, which are used in the preparation of human specimens, do not fall within the scope of IVDR and therefore must not be CE-IVD marked, but are instead classified as General Laboratory Use (GLU) / General Laboratory Reagents (GLR).

As a result, Histolab is reviewing and updating the classification and labeling of affected products to ensure full compliance with applicable regulatory requirements.

This change does not affect the product’s quality, performance, safety, or intended use in laboratory workflows.

Affected products

A list of affected products, including article numbers, is published below and will be updated on an ongoing basis as information becomes available.

More information

The official EU guidance document is available here:
👉 MDCG 2024-11 – Guidance on qualification of in vitro diagnostic medical devices

If you have any questions, please contact your regular Histolab representative.