In the context of the COVID-19 pandemic, the Health Security Committee established in May 2021 a Technical working group on COVID-19 diagnostic tests, bringing together experts from the 27 EU countries and Norway, as well as representatives from the Directorate-General for Health and Food Safety, the Joint Research Centre (JRC) and the European Centre for Disease Prevention and Control (ECDC).
The aim of the technical working group is, in particular, to review the proposals put forward by EU countries as well as manufacturers for COVID-19 rapid antigen devices to be included in the EU common list of rapid antigen tests. The technical working group will assess these proposals against the criteria established by Council Recommendation EU 2021/C 24/01 as well as further criteria that were agreed by the experts on 21 September 2021. Moreover, the technical working group agreed on 6 July 2021 that the common list does not include rapid antigen self-tests. A negative test result based on nasal, oropharyngeal and/or nasopharyngeal specimens and produced by all of the rapid antigen tests included in the EU common list can be used for the issuance of the EU Digital COVID Certificate.
In case the technical working group considers that an update of the EU common list of rapid antigen tests is required, a proposal will be presented to the Health Security Committee (HSC) for formal agreement. Updates of the EU common list of rapid antigen tests may concern additions and/or removals of rapid antigen tests, or updates regarding the availability of data and information (e.g. use of specific devices by countries or the publication of new validation studies). An addendum is published alongside every update of the common list, setting out further details and background information to the decisions taken by the technical working group.
As of July 2021, the technical working group also reviews proposals put forward by EU countries and manufacturers for COVID-19 laboratory based antigenic assays for inclusion in the common list of lab-based antigenic assays. These proposals are assessed against the same criteria as the rapid antigen tests (as agreed on 21 September 2021). Note that, at this stage, a negative test results produced by a lab-based antigenic assays cannot be used for the issuance of the EU Digital COVID Certificate.
The technical working group meets once a month, and further updates to the common list of COVID-19 rapid antigen tests and/or the common list of COVID-19 lab-based antigenic assays will be made as soon as relevant new data and information becomes available and has been carefully assessed by the technical experts.
Common list of COVID-19 rapid antigen tests
- EU health preparedness: A common list of COVID-19 rapid antigen tests and a common standardised set of data to be included in COVID-19 test result certificates; and a common list of COVID-19 laboratory based antigenic assays – agreed by the HSC
- Addendumto the common list of COVID-19 rapid antigen tests –agreed by the HSC
- Background document, providing further details to the definitions, scope, considerations and criteria to be applied to independent validation studies assessing the clinical performance of rapid antigen tests for COVID-19 diagnosis as defined in the common list of COVID-19 rapid antigen tests
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Submission of information by manufacturers
In order for devices to be included in the EU common list of rapid antigen tests, it is essential for manufacturers to ensure that their device is included in the COVID-19 In Vitro Diagnostic Medical Devices, hosted by the JRC.
Manufacturers are invited to submit information on new devices not yet listed or to update information on devices already included in the database using the ‘Submit/Update your device’ function that can be found at the bottom of the JRC COVID-19 database. Once verified for completeness, the information will be added to the database. The database is updated once a week and new and updated submissions become visible online in the course of the week following the submission date.
Once a device has been included, a device ID number becomes available. With this information, the manufacturer can now submit a specific request for the device to be included in the HSC agreed common list of rapid antigen tests. This can be done by completing this survey. The submitted information, once verified against the source provider, will be forwarded to the HSC technical working group for evaluation and review.
- Council Recommendation EU 2021/C 24/01 on a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the EU
- Commission Recommendation (EU) 2020/1743 of 18 November 2020 on the use of rapid antigen tests for the diagnosis of SARS-CoV-2 infection
- Commission Recommendation (EU) 2020/1595 of 28 October 2020 on COVID-19 testing strategies, including the use of rapid antigen tests
- ECDC - Considerations on the use of rapid antigen detection (including self-) tests for SARS-CoV-2 in occupational settings, 6 May 2021
- ECDC - Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK, 19 November 2020
In case of questions related to the working procedures of the HSC technical working group on COVID-19 diagnostic tests, please contact: SANTE-TWG-RAT@ec.europa.eu
For technical questions related to the COVID-19 In Vitro Diagnostic Medical Devices database and the submission of information by manufacturers, please contact: JRC-COVID-DIAGNOSTICS@ec.europa.eu
The European Commission does not provide details on the discussions held during the meetings of the technical working group nor does it share the contact details of its members.
Moreover, please note that the EU common list of COVID-19 rapid antigen tests is non-exclusive. This means that other rapid antigen tests - not included in the list - can be put on the EU market, if they correspond to the requirements valid in the Member State(s). In this context, it is not in the competence of the Commission to assess or limit an access to the markets of the EU countries, i.e. to decide, which rapid antigen tests can be put on the market in each country. The Commission can therefore not be held responsible, if an access to the market of the Member State(s) was not granted to a particular product.