What Changes for the Classification of IVD Controls
The MDCG published Revision 5 of MDCG 2020-16, the guidance on classification rules for in vitro diagnostic medical devices under Annex VIII IVDR (Regulation (EU) 2017/746). The change is targeted and affects only Rule 7. All other classification rules remain unchanged from Revision 4 of March 2025. For manufacturers of control materials, this is the moment to review the affected technical documentation.
What does Rule 7 cover?
Rule 7 classifies controls without an assigned quantitative or qualitative value as Class B. Revision 5 refines the rationale and updates the examples. The focus is on standalone controls that laboratories use to monitor the validity of their examination procedures. This addresses a question that has frequently caused uncertainty in practice.
Does this affect US manufacturers?
Yes, if you place IVD controls on the EU market. The IVDR applies to every device made available in the European Union, regardless of where the manufacturer is based. US manufacturers of control materials should treat Revision 5 as a prompt to confirm the classification of the products concerned.
What does this mean for manufacturers?
There are multiple points to consider:
Intended Purpose
Is the control clearly defined as material for monitoring the validity of examination procedures?
Value Assignment
Has a quantitative or qualitative value been assigned?
IFU
Is the statement to be read as an assigned value or only as an indication
Consistency
between classification rationale, intended purpose, IFU, labeling, and technical documentation
What is the next step?
An unclear classification under Rule 7 leads to a deficiency from the notified body and costs time in the procedure. WQS reviews the classification of your control materials against Revision 5 and aligns the technical documentation accordingly.
