Coronavirus: how should tests be made available in Belgium?

date: 30/04/2020

Belgian manufacturers of COVID-19 tests for professional use and Belgian authorised representatives of foreign manufacturers must notify the FAMHP when placing their tests on the market. This notification does not constitute an offer of equipment to the Belgian state. Companies wishing to offer tests to the government must contact the FPS Public Health.

Several types of tests for COVID-19

The types of tests used for COVID-19 are as follows:

  • Nucleic acid test (e.g. PCR): this primarily involves a swab of the nose and throat. The presence of the virus is then detected in the sample taken.
  • Antigen test: this primarily involves a swab of the nose and throat. This test also detects the presence of the virus. 
  • There are “rapid” antigen tests, where the sample is placed on a plate and the result appears after a few minutes.
  • There are also ELISA (enzyme-linked immunosorbent assay) or “ELISA-like” tests which are more complex but offer a more reliable and qualitative method.
  • Antibody test (IgG/IgM/IgA): blood sample. This test makes it possible to detect antibodies against the virus in the sample taken.
  • Antibody tests can also be performed via “rapid” tests, or via ELISA or “ELISA-like” tests.

The Risk Management Group (RMG) determines the strategy and criteria for determining which people are tested and with what types of tests.

No need for FAMHP approval

Tests that have been created for use by healthcare professionals to detect the virus that causes COVID-19 or to detect antibodies to COVID-19 do not require approval from the FAMHP to be placed on the market.

For marketing within Belgium and the European Union, the manufacturer of the tests for professionals must complete a self-certification. Self-certification notably requires compliance with the essential requirements of European Directive 98/79/EC. Once this self-certification is complete, the CE marking may be affixed on the product. This marking means that it complies with current legislation, as well as with quality, safety and efficiency standards. Some manufacturers have voluntarily obtained approval from accredited laboratories in Belgium, but this laboratory validation is not mandatory for manufacturers or other actors who wish to sell their test on the Belgian market, as long as their test bears the CE marking.

The Belgian manufacturer, or its authorised representative, must notify the competent authority in the country in which its head office is located (the FAMHP for Belgium) of the test’s placement on the market on the day of said placement at the latest. The manufacturer does not have to wait for a response before placing the test on the market. The FAMHP has not introduced any bans for tests intended for health professionals.

Companies (distributors) that distribute tests related to COVID-19 on the Belgian market must register with the FAMHP through a specific web portal.

List of tests recommended by the FAMHP and Sciensano

Since the emergence of the COVID-19 pandemic, numerous tests have appeared on the European market. These tests detect either the presence of the virus (e.g. PCR tests and antigen tests) or the presence of antibodies against the virus.

The reliability of tests, particularly those detecting antigens and antibodies, is not always clearly proven and documented. For this reason, the FAMHP and Sciensano have decided to draw up a list of tests which meet certain minimum criteria. Manufacturers of these tests can find the procedure to follow to appear on this list, as well as the qualification criteria.

Contact the FPS Public Health to offer stocks of tests to the Belgian state

Any companies wishing to offer tests to the Belgian state can do so by completing the application on the website.

Ban on sale of self-tests to non-professionals

In the context of COVID-19, only tests intended for self-diagnosis by the patients themselves (such as home pregnancy tests) and sterile devices must be approved by a notified body to obtain CE marking. A notified body is a private company designated by the competent authorities. This approval takes considerable time. As a precautionary measure to avoid misinterpretation of results, the FAMHP banned the sale, distribution and use of rapid self-testing for the detection of antibodies against the new coronavirus (SARS-CoV-2) for six months.

Last updated on 09/05/2020