The European Commission has published MDCG 2020-16 Rev. 5, the latest version of the guidance on the classification of in vitro diagnostic medical devices under Regulation (EU) 2017/746. The revised document was released on 9 September 2026 by the Medical Device Coordination Group (MDCG).
Updated Rule 7 clarification
The only change introduced in this new revision concerns Rule 7. Specifically, the new version updated the clarification of the rationale and revision of examples. Rule 7 covers devices which are controls without a quantitative or qualitative assigned value, typically classified as Class B under the EU IVDR.
IVDR classification rules explanation
Annex VIII of the IVDR establishes seven classification rules that determine the risk class of an IVD device:
- Rule 1 covers devices intended for the detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues, organs, or their derivatives to assess their suitability for transfusion, transplantation, or cell administration. It also includes devices intended to detect life-threatening transmissible diseases or determine their infectious load.
- Rule 2 applies to devices intended for blood grouping or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissues, or organs intended for transfusion, transplantation, or cell administration. Certain exceptions apply.
- Rule 3 covers a broad range of Class C devices, including those intended for:
- detecting sexually transmitted agents;
- detecting infectious agents in cerebrospinal fluid or blood where there is no high risk of propagation;
- detecting infectious agents where an erroneous result could lead to death or severe disability;
- determining immune status towards transmissible agents in prenatal screening;
- determining infective disease status or immune status where an incorrect result could result in a life-threatening patient management decision;
- use as companion diagnostics;
- disease staging where an incorrect result could lead to a life-threatening patient management decision;
- cancer screening, diagnosis, or staging;
- human genetic testing;
- monitoring medicinal products, substances, or biological components where an erroneous result could lead to a life-threatening patient management decision;
- managing patients suffering from life-threatening diseases or conditions; and
- screening for congenital disorders.
- Rule 4 applies to devices intended for self-testing and near-patient testing. Most self-testing devices are classified as Class C, although certain tests, such as those for pregnancy, fertility, cholesterol, glucose, erythrocytes, leucocytes, and bacteria in urine, are generally classified as Class B. Near-patient tests are classified according to their intended purpose and the applicable classification rule.
- Rule 5 covers specimen receptacles, instruments specifically intended for in vitro diagnostic procedures, and certain laboratory products intended by the manufacturer for use in IVD procedures.
- Rule 6 serves as the residual rule: devices that are not covered by Rules 1 to 5 are classified as Class B.
- Rule 7 classifies controls without an assigned qualitative or quantitative value as Class B devices.
For any questions on compliance of medical devices and IVDs, contact us here or at mdlaw@obelis.net.
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