MDCG 2020-16 Rev. 4: Update on the Classification of In Vitro Diagnostic Devices (IVDs)
The Medical Device Coordination Group (MDCG) has published Revision 4 of MDCG 2020-16, introducing important adjustments to the classification of in vitro diagnostic medical devices (IVDs) under IVDR Regulation (EU) 2017/746. The main change in this revision involves the reclassification of SARS-CoV-2 tests, as well as new clarifications on classification rules for other types of diagnostic tests.
Main Changes in the Classification of SARS-CoV-2 Tests
The revision incorporates the decision of the European Commission's Panel of Experts of January 29, 2024, which resulted in the reclassification of COVID-19 tests. Devices now follow the following rules:
Class A - Lay sampling devices (Rule 5)
Class B - Professional antigen/antibody tests (Rule 6)
Class C - Self-diagnostic tests for antigen/antibody detection (Rule 4)
This update reduces the level of risk attributed to some SARS-CoV-2 tests, making the certification process less complex for manufacturers who produce rapid tests for COVID-19. However, self-diagnostic tests still require a stricter level of control due to their direct use by patients.
Other Important Updates to the Classification of IVDs
In addition to the changes to the COVID-19 tests, the MDCG has introduced adjustments and clarifications to other classification rules:
Rule 1 - Revision of the criteria for tests to detect transmissible agents, ensuring greater precision in the categorization of laboratory tests.
Rule 3(m) - Adjustment to the footnote for complementary diagnoses, clarifying the conditions for its application.
Rule 4(a) - Revised examples for self-testing devices, including new categories of products that fall under this classification.
Rule 6 - Adjustments to the classification for blood, tissue and organ screening tests, ensuring alignment with current clinical requirements.
Annexes 1 and 2 - Editorial revisions to improve the clarity and applicability of the guidelines.
Impact for Manufacturers and Next Steps
With this update, IVD manufacturers will need to review their classifications to ensure compliance with the IVDR. The reclassification of COVID-19 tests may simplify the certification of some products, but reinforces the need for post-market monitoring and risk management, especially for self-diagnostic devices.
In addition, manufacturers should consider possible impacts on their certification processes, ensuring that compliance and documentation requirements are appropriate to the new classification.
Access the full MDCG 2020-16 Rev. 4 document below.
