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. This technical working group brings together experts from the 27 EU countries and Norway, as well as representatives from the Directorate-General for Health and Food Safety (DG SANTE), 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 devices to be included in the EU common list of COVID-19 antigen tests. The technical working group, which meets on average once a month, assesses these proposals against the criteria established by Council Recommendation EU 2021/C 24/01 as well as criteria agreed by the Health Security Committee on 21 September 2021.
In case the technical working group considers that an update of the EU common list of COVID-19 antigen tests is required, a proposal is presented to the Health Security Committee for formal agreement. Such updates may concern additions and/or removals of antigen tests, or updates regarding the availability of data and information (e.g. the publication of new validation studies). An addendum is published alongside every update of the EU common list, setting out further details and background information regarding the decisions taken by the technical working group.
All the antigen tests included in the EU common list are eligible for the issuance of EU Digital COVID Certificates. Note that COVID-19 antigen self-tests are not included in the EU common list of COVID-19 antigen
Common list of COVID-19 antigen tests
- The EU common list of COVID-19 antigen tests – agreed by the Health Security Committee
- Addendum to the EU common list of COVID-19 antigen tests – agreed by the Health Security Committee
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Submission of information by manufacturers
Firstly, in order for devices to be included in the EU common list of COVID-19 antigen tests, manufacturers should ensure that their device is included in the COVID-19 In Vitro Diagnostic Medical Devices, hosted by the JRC. This can be done by submitting the required information using the ‘Submit/Update your device’ function that can be found at the bottom of the following webpage. The database is updated once a week. New and updated submissions become visible online in the course of the week following the submission date.
Secondly, once a device has been included in this database, 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 EU common list of COVID-19 antigen tests. This can be done by clicking on the relevant link of the function ‘Submit info for the EU common list’ that can be found at the bottom of the following webpage.
Note that submission of applications to the database does not imply the automatic inclusion of proposed devices in the EU common list. The information and documentation provided first needs to be analysed by the technical working group and then agreed by the Health Security Committee.
- 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 – first update, 26 October 2021
In case of questions related to the working procedures of the 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 antigen tests is non-exclusive. This means that other 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 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.