As part of the common framework for the use of rapid antigen tests, the Health Security Committee (HSC) of the European Union implemented a common list of COVID-19 rapid antigen tests.
To sell the tests in the EU market, it is not mandatory to be on the HSC list. However, important factors encourage manufacturers to apply to the list.
The Representative of choice for
Manufacturers of COVID-19 rapid antigen tests are invited to apply to be on the HSC list for several reasons. Among others:
- Manufacturers of antigen tests must know that some distributors and imports might require that the tests are on the list before they agree to cooperate with the manufacturer.
- EU Member States are strongly encouraged to ensure that only test results from the evaluated specimen type(s) are used to issue EU Digital COVID certificates. In other words, EU countries are invited to use antigen tests which are on the HSC list.
For the HSC list registration, manufacturers need to obtain a device ID for their rapid antigen tests. Devices get this ID once they are part of the JRC database, the Joint Research Centre (JRC) COVID-19 In Vitro Diagnostic Devices and Test Methods database. Among other things, the database contains all publicly available information IVDs used for COVID-19.
To this database, manufacturers can submit a new nucleic acid – PCR-based device, a new immunoassay device, and a new PCR-based molecular assay. For the application, the information to provide are:
- General information on the device and manufacturer
- Test information
- Any additional information
Overall, the application to be included in the HSC list foresees the following steps:
- Once a device is on the JRC database and has a device ID, the manufacturer can apply for the HSC list.
- The Technical Working Group will analyse the information provided, which are subsequently approved by the Health Security Committee.
- The HSC list is updated regularly. Once an application is accepted, the updated EU common list is published on the Commission’s website and the COVID-19 In Vitro Diagnostic Devices and Test Methods Database.
Notably, the HSC list does not include IVD devices solely based on sampling materials other than nasal, oropharyngeal, or nasopharyngeal specimens, self-tests, and pooled tests.
For both the JRC database and the HSC list applications, Obelis takes care of all steps.
Our services include verification of information to submit, submission of the application on behalf of the manufacturers, application for update or resubmission.
With the new Regulation on IVD medical devices, COVID-19 antigen tests are up-classified to the highest risk class, class D. This implies that such tests need a CE Certificate and therefore, the intervention of a Notified Body is necessary under IVDR. Nonetheless, there is a grace period for antigen tests until May 2027 which gives manufacturers more time to reach compliance with the Regulation.
Nevertheless, manufacturer should continue respecting the previous Directive as well as some legacy requirements of the Regulation as of May 2022.
On top of these requirements, if you are a non-EU manufacturer, it is mandatory to appoint a European Authorised Representative (EAR) in order to place IVDs on the European Market.
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
