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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Additional information for manufacturers

This page contains additional and important information for manufacturers.
Manufacturers are invited to visit this page regularly in order to be timely informed on relevant news and updates.

  • 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.