26-07-2023 IMPORTANT: Please note that the work of the technical working group on COVID-19 diagnostic tests has formally ended.
Manufacturers were able to submit applications for antigen devices to be included in the EU common list until 31 March 2023, 23:59 CET. Since then, no new applications have been considered or assessed.
The technical working group and its activities formally stopped on 30 June 2023, with the end of validity of the EU Digital COVID Certificate Regulation.
08-03-2023 IMPORTANT NEWS on HSC Technical Working group activity
Please note that the Health Security Committee has decided that the work of the technical working group on COVID-19 diagnostic tests will be discontinued. Manufacturers can submit applications for antigen devices to be included in the EU common list until 31 March 2023, 23:59 CET.
After this date, neither applications nor further details submitted by email will be considered or assessed. The final update of the EU common list is expected to be published by the end of April 2023.
The technical working group and its activities will formally come to an end once the EU Digital COVID Certificate Regulation is no longer in force.
10-11-2021 Rapid antigen tests that use a mix of different sampling materials
As stated in the latest version of the document EU health preparedness: A common list ofCOVID-19 rapid antigen tests and a common standardised set of data to be included in COVID-19 test result certificates, Rapid antigen tests that are using a mix of different sampling materials (i.e. nasal, oropharyngeal and/or nasopharyngeal swabs as well as other specimen types such as saliva) can be included in the EU common list. However, the validation studies of such tests should present the results and data for each specimen type separately.
Only the validation results based on nasal, oropharyngeal and/or nasopharyngeal swabs of such devices will be reviewed by the Technical Working Group and assessed against the specified criteria.
Only test results based on nasal, oropharyngeal and/or nasopharyngeal specimens should be valid for the issuance of test certificates for the EU Digital COVID Certificate.
Rapid antigen tests that are solely based on other sampling materials, such as saliva, sputum, blood and/or faeces, are not included in the EU common list of antigen tests, as well as rapid antigen self-tests.
04-11-2021 Triton X-100
Note concerning Triton X-100 in rapid test kits
If Triton X-100 is contained in the rapid test kit this needs an authorisation under the REACH Regulation. The latest application date is 22 June 2022. If you intend to apply, please make a notification to the European Chemicals Agency (ECHA) here
This will enable the Agency to give procedural advice to Manufacturers and be prepared to receive applications.