MDCG 2020-16 Rev. 5 – New IVDR Classification Clarifications for QC Controls
On 9 September 2026, the Medical Device Coordination Group (MDCG) published MDCG 2020-16 Revision 5 – Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (IVDR). The update is focused and introduces clarifications to Rule 7, including revisions to the rationale and examples relating to controls without a quantitative or qualitative assigned value.
What's New?
The revision concerns Rule 7, which classifies controls without a quantitative or qualitative assigned value as Class B devices. Revision 5 provides:
Clarified Rationale for Standalone QC Materials
Clarified rationale regarding the intended purpose and classification of standalone quality control (QC) materials.
Scope of Standalone QC Materials
Additional explanation that the intended purpose of standalone QC materials is limited to monitoring the validity of laboratory examination procedures, and that they cannot replace mandatory control materials required to verify the performance of an IVD.
Revised Examples
Revised examples illustrating the types of controls that fall under Rule 7, including:
- Unassigned control sera
- Non-assay specific coagulation controls
- Non-assay specific biochemical controls
- Non-assay specific ISH controls
Distinction from Other Controls
The guidance continues to distinguish these controls from:
- Controls with quantitative or qualitative assigned values, which are classified according to Implementing Rule 1.6 of IVDR Annex VIII.
- Internationally certified reference materials and external quality assessment (EQA) materials, which are not considered IVDs under the IVDR.
What Does This Mean to You?
Manufacturers of quality control materials should review their product portfolios and intended purposes to confirm that classification remains consistent with the updated MDCG interpretation of Rule 7. Particular attention should be given to whether controls have assigned values and whether they are intended as standalone QC materials or assay-specific controls.
The additional clarification may also be useful when preparing classification justifications and technical documentation for control materials and related products.
How Can QbD Group Assist You?
QbD Group's Regulatory Affairs and IVDR experts support IVD manufacturers with classification assessments, technical documentation, and quality control material portfolio reviews under the IVDR. Contact our team to review your classification strategy in light of MDCG 2020-16 Revision 5.