Targeted Revision on Rule 7 Controls
The European Commission published Revision 5 of MDCG 2020-16, the benchmark guidance governing classification rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR).
Unlike earlier broad updates that amended multi-rule provisions or kit definitions, Revision 5 focuses specifically on clarifying the rationale, regulatory boundaries, and practical examples for Rule 7 in Annex VIII of the IVDR. Rule 7 governs control materials without quantitative or qualitative assigned values.
Key Clarifications and Regulatory Boundaries
The updated guidance provides targeted clarifications regarding how manufacturers and notified bodies must evaluate control materials:
- Definition of Assigned Values: Providing concentration ranges, recommended intervals, or parameter windows in instructions for use (IFU) for a laboratory to establish its own target values does not constitute an assigned value. Such products remain unassigned control materials and are classified as Class B under Rule 7.
- Precedence of Implementing Rule 1.6: Where control materials possess quantitative or qualitative assigned values, or are designed to be used in conjunction with specific IVD reagents or assay platforms, Implementing Rule 1.6 applies. These materials inherit the risk classification of the device they support (Class B, Class C, or Class D) rather than defaulting to Class B under Rule 7.
- Role of Independent Quality Controls: Independent quality control (QC) materials intended to monitor laboratory examination procedures fall within IVDR scope as IVD devices. However, the guidance clarifies that independent controls cannot substitute for mandatory assay-specific controls required to verify analytical performance.
- Out-of-Scope Exclusions: International certified reference materials and materials utilized for External Quality Assessment (EQA / proficiency testing) schemes remain excluded from the scope of Regulation (EU) 2017/746 under Article 1(3), and are therefore not subject to Rule 7 classification.
- Updated Practical Examples: The guidance incorporates revised and expanded real-world examples, including unassigned control sera, immunochromatographic migration controls, unassigned heterozygote controls, non-assay-specific coagulation plasma, multi-analyte control sera, and non-assay-specific DNA/RNA probes for in situ hybridization.
Practical Checks for Manufacturers
Manufacturers marketing or developing IVD quality controls and related reagents should review their current classification rationale against the updated guidance:
- Audit IFU Wording and Value Assignment: Review technical documentation for control materials currently registered or planned as Class B. Verify whether IFU text contains fixed assigned values or purely guidance intervals for laboratory calibration.
- Examine System Linkages: For controls distributed alongside reagent kits or dedicated instruments, confirm whether the product meets criteria for Implementing Rule 1.6 rather than isolated Rule 7 classification.
- Align Intended Purpose in Technical Documentation: Ensure intended purpose claims in the CE technical file explicitly delineate between analytical process monitoring and direct measurement accuracy verification.
Sources
- Primary official sourceMDCG 2020-16 rev.5 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (September 2026) (opens in a new tab)European Commission