On 9 September 2026, the Medical Device Coordination Group (MDCG) published Revision 5 of the guidance document MDCG 2020-16 on the application of the classification rules under Annex VIII of Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices. The revision amends the section of the guidance concerning Rule 7 of Annex VIII, clarifying the rationale and updating practical examples to resolve the frequent implementation uncertainties encountered across the sector. All other classification rules remain unchanged from Revision 4 of March 2025.

Rule 7: Controls Without Assigned Values Fall into Class B

Rule 7 of Annex VIII to the IVDR states:

“Devices that are controls without a quantitative or qualitative assigned value are classified as class B.”

Revision 5 clarifies the practical application of this provision, focusing particularly on standalone controls used by laboratories to monitor the validity of their examination procedures. The core of the clarification lies in distinguishing between controls without assigned values and controls to which the manufacturer has assigned a quantitative or qualitative value:

• Controls without quantitative or qualitative assigned values (standalone): when the control lacks a quantitative or qualitative value assigned by the manufacturer, Rule 7 applies and the device is classified as Class B, unless another rule applies. The manufacturer may state the presence of an analyte or a concentration range in the IFU. Rev. 5 clarifies that such information does not in itself constitute an “assigned value”. Indeed, the target values used by the laboratory in routine practice may be established by the laboratory itself on its own instrumentation. The IFU must also clarify that the intended purpose of standalone controls is strictly limited to monitoring the validity of laboratory examination procedures, and that such materials do not replace controls that may be required to verify the performance of the IVD.
• Controls with quantitative or qualitative assigned values: controls to which the manufacturer has assigned a quantitative or qualitative value, including run controls associated with a diagnostic kit, are classified under Implementing Section 1.6 of Annex VIII.

This clarification can have a significant impact on manufacturers, making it clear that the classification of a standalone control does not depend merely on the nature of the analyte it contains. Consequently, standalone control may contain analytes associated with Class C or Class D devices without automatically triggering a classification in the same risk class.

Practical Examples in Rev. 5 and Exclusions

To support the application of Rule 7, Rev. 5 lists several examples of controls classified as Class B:

• Unassigned control sera;
• Control materials used to verify migration in immunochromatographic assays;
• Unassigned heterozygous controls for nucleic acid extraction, amplification, and detection;
• Coagulation control plasma not assay-specific;
• Non-specific multi-analyte control sera;
• DNA/RNA probes provided as a non-specific normal control in in situ hybridization (ISH).

The examples provided in the Guidance are illustrative and not exhaustive.

As a reminder, the guidance also notes that internationally certified reference materials and materials used in external quality assessment (EQA) schemes are excluded from the scope of the IVDR pursuant to Article 1(3), points (c) and (d).

Guidance for Manufacturers

IVD classification determines the applicable conformity assessment route, the level of Notified Body involvement, and the documentation required to demonstrate device conformity.

For manufacturers, Revision 5 provides an opportunity to review the technical documentation of controls falling under Rule 7, verifying in particular:

• A clear definition of the intended purpose as material dedicated to monitoring the validity of laboratory examination procedures;
• Whether any quantitative or qualitative value has been assigned by the manufacturer;
• The distinction between an assigned value and indicative information provided in the IFU;
• The potential applicability of another classification rule;
• Full consistency among classification rationale, intended purpose, IFU, labelling, and technical documentation.

>>> Complife supports manufacturers of in vitro diagnostic medical devices in the correct implementation of IVDR requirements, offering strategic regulatory consulting and specialized training.

SOURCE:

MDCG 2020-16 rev. 5