Important news for COVID-19 test manufacturers: change in the classification of rapid antigen tests

TEAM-NB (The European Association for Medical Devices of Notified Bodies) published a press release on April 4, 2025, alerting manufacturers to a critical change in the regulatory classification of rapid antigen tests for COVID-19 in the European Union.

With the entry into force of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), rapid antigen tests for COVID-19, previously classified as List A devices under Directive 98/79/EC (IVDD), are now considered Class D devices under the new IVDR regulation. This new classification reflects the high risk associated with the use of these tests and imposes significantly stricter requirements on manufacturers.

TEAM-NB emphasizes that, as a result, manufacturers of these tests must now involve a Notified Body (NB) in the conformity assessment of their products, including audits of the quality management system, evaluation of technical documentation, and performance verification through EU reference laboratories, where available.

Additionally, certificates issued under the IVDD are no longer valid for these devices—that is, the IVDR transitional regime does not apply in this specific case. Therefore, manufacturers who have not yet started the CE marking process under the IVDR must act urgently to ensure the legal continuity of their products' supply on the European market.

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