IVD controls without assigned values: what MDCG 2020-16 rev.5 clarifies
Revision 5 of MDCG 2020-16 (September 2026) changes only Rule 7 of the IVDR. We explain where the class B boundary now lies for quality control materials.
🧪 Many manufacturers of control materials provide indicative information in the IFU about the analytes their product contains. Does that information turn the control into a device “with assigned values” and take it out of class B? Revision 5 of MDCG 2020-16, published on 9 September 2026, gives a written answer.
📌 One change, not an overhaul
The document’s change table lists a single entry: Rule 7, clarification of the rationale and revision of examples. The rest of the guidance is unchanged from rev.4 of March 2025.
⚖️ Where the boundary lies
Rule 7 still classifies controls without a quantitative or qualitative assigned value as class B. What is new is the criterion: a range of values, or an indication of the presence of the analyte, provided by the manufacturer in the IFU, does not constitute an assigned value. The target values used routinely are set by the laboratory, which is the party required to continuously monitor the validity of its examination results; the manufacturer’s information serves to let the laboratory check that the control is suitable for its method.
On the other side are controls with values assigned by the manufacturer, including assay kit validity controls, which are classified under implementing rule 1.6 and take the class of the reagent they accompany. The guidance also recalls that internationally certified reference material and materials used for external quality assessment schemes are not IVDs (Article 1(3)(c) and (d)).
✅ Two conditions for the manufacturer
📄 The first is the intended purpose: the IFU must clearly state that the standalone control is limited to monitoring the validity of laboratory examination procedures and that it cannot replace the mandatory QC materials required to verify the performance of the IVD itself.
🔬 The second is suitability for the method: the guidance requires the material to possess properties that make it suitable for the specific examination method being monitored, and that is demonstrated in the performance evaluation, not merely declared.
🧭 What this means at MeDev Consulting
For manufacturers of control materials, rev.5 translates into a well-defined review: checking the classification rationale in the technical documentation against the new Rule 7 reasoning, confirming that the IFU limits the intended purpose in the terms the guidance requires, and verifying that the performance evaluation supports the suitability of the control for the method. It is a limited-scope adjustment that prevents indicative information from ending up reclassifying the device.
💬 If you place standalone quality control materials on the market under the IVDR and would like a second reading of your technical documentation in light of rev.5, MeDev Consulting can help.
🔗 Related service: Technical documentation (TF) and quality management system (QMS) under MDR/IVDR → /en/servicios/tf-qms/
📚 Source: MDCG 2020-16 rev.5, European Commission, September 2026.