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22nd January 2021  Product update: rapidmicrobiology staff writer

EU Member States To Create Common List of COVID-19 Rapid Antigen Tests

Member states have unanimously agreed, by written procedure, on a Council recommendation setting a common framework for the use of rapid antigen tests and the mutual recognition of COVID-19 test results across the EU.

This is a central tool to help mitigate the spread of the virus and contribute to the smooth functioning of the internal market; the mutual recognition of test results for SARS-CoV2 infection carried by certified health bodies is essential to facilitate cross-border movement, cross-border contact tracing and treatment.

Key components of this recommendation include the validation and mutual recognition of rapid antigen tests and RT-PCR tests among member states, the sharing of a standardised set of data (through a digital platform), the development of a common list of COVID-19 rapid antigen tests, the prioritisation of situations for the use of such tests (e.g. contacts of confirmed cases, outbreak clusters) and more.

The recommendation also includes future-proof provisions to address the challenges of the evolving pandemic: the common list of appropriate COVID-19 rapid antigen tests should be flexible enough for addition or removal of those tests whose efficacy is impacted by COVID-19 mutations.

European leaders invited in December 2020 the Commission to present a proposal for a Council Recommendation on a common framework for rapid antigen tests and for the mutual recognition of test results. The Commission presented its proposal on 18 December 2020.

This recommendation was negotiated in the relevant bodies of the Council and adopted under the Portuguese Presidency. The Council Recommendation is not legally binding; it sets out best practices, which member states are encouraged to follow.

EU Directives
The currently applicable regulatory framework for placing rapid antigen tests on the market is Directive 98/79/EC. According to the Directive, for SARS-CoV-2 rapid antigen tests, the manufacturer must draw up a technical file which explicitly shows that the test is safe and performs as intended by the manufacturer, by demonstrating compliance with the requirements laid down in Annex I of the Directive. 

From 26 May 2022, Directive 98/79/EC will be replaced by Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Under the Regulation, rapid antigen tests will be subject to reinforced requirements on device performance and a thorough assessment by a notified body. This may reduce the additional effort required for the validation of these tests prior to their use as part of national strategies



Date Published: 22nd January 2021

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.