On March 18, 2025, the Commission’s Directorate-General for Health and Food Safety published Revision 4 of MDCG Guidance 2020-16, dedicated to the classification of in vitro diagnostic Medical Devices (IVDs) according to the IVDR Regulation (EU) 2017/746.
The document clarifies the application of Annex VIII rules, helping manufacturers, notified bodies and health institutions to correctly determine the risk class of IVDs (Class A, B, C and D, where Class D represents the highest risk) before placing them on the market.
Accurate IVD classification is the first essential step in defining the applicable regulatory requirements, including technical documentation, compliance procedures and post-market surveillance obligations for IVDs.
The publication of Revision 4 (March 2025), just a few months after Revision 3 (July 2024), underlines the dynamic nature of IVDR implementation and the importance for manufacturers to adapt promptly.
Although the guidance is not legally binding, practitioners, in particular manufacturers, should consider it as a key reference point for good practice for compliance with the legally binding IVDR Regulation (EU) 2017/746.
The guidance promotes a consistent and harmonised application of classification rules throughout the European Union.
IVD classification: Key Updates in Revision 4 of MDCG 2020-16
- Reclassification of SARS-Cov-2 tests: self-diagnostic tests for SARS-Cov-2 were reclassified to Class C (previously Class D), while tests for professional use were reclassified to Class B (previously Class D). Note that IVDs for the detection of SARS-Cov and its emerging strains, as well as for vulnerable groups, remain in Class D, the highest.
This reclassification reflects a significant change in the population’s perception of the risk associated with SARS-Cov-2. - Revision of examples for Rule 1 (Transmissible Agents): the examples for IVD devices for the detection of transmissible infectious agents such as viruses, bacteria and other pathogens have been updated.
- Revision of examples for Rule 4(a) (Self-testing): updated examples for self-testing devices to better clarify classification according to biomarkers.
- Amendment of footnote 8 in Rule 3 (m) (Congenital Diseases): The footnote has been amended to better clarify the interpretation of the rule; in particular, more precise information has been provided for neonatal screening, in the direction of greater consistency with clinical practice.
- Minor editorial changes to Annexes 1 and 2: minor wording and structure changes were made to improve the overall readability of the document.
- Strengthened emphasis on intended use: Revision 4 reaffirms the critical and fundamental role of the intended use declared by the manufacturer for the IVD in determining its classification.
The importance of IVD classification given the upcoming IVDR deadlines
With the approaching deadlines introduced by IVDR (EU) 2023/607, the correct classification of Legacy IVDs becomes a strategic step. By May 26, 2025, manufacturers must have adapted their quality management system to IVDR and submitted a formal request to a notified body. The timing for the conformity assessment varies according to the risk class of the device.
In this scenario, Revision 4 of the MDCG 2020-16 is an essential tool for navigating the regulatory transition. Indeed, a correct IVD classification directly influences the level of evidence required and the timeframe for CE marking.
The MDCG guidelines, while not legally binding, are the gold standard for a correct interpretation of the IVDR Regulation (EU) 2017/746. Competent authorities and notified bodies expect them to be followed as proof of good practice. Deviating from these indications is possible, but requires solid and well-documented technical justifications, with the risk of incurring stricter controls and non-compliance.
Following the MDCG guidelines is a sure way to navigate, achieve compliance and meet the deadlines set by the IVDR and (EU) Regulations 2024/1860.
>>> Thema experts can give you full support in the correct application of the classification rules for in vitro diagnostic Medical Devices and the pathway to compliance with the IVDR (EU) 2017/746.
04/15/2025
