Making COVID-19 tests available in Belgium

date: 30/04/2020

The FAMHP no longer provides specific validation or verification procedures for COVID-19 tests, nor are there any restrictions for making these tests available on the Belgian market and no specific recording for these tests made available on the Belgian market.

Economic operators are also allowed to make COVID-19 tests available in Belgium that comply with the legislation applicable to in vitro diagnostic medical devices (IVDs). Since 26 May 2022, IVDs must comply with Regulation (EU) 2017/746 on in vitro diagnostic medical devices. However, transitional periods are still provided that, under specific conditions, allow placing IVDs on the market under the previous legislation (Directive 98/79/EC on in vitro diagnostic medical devices). More information on the transition periods (see question 8 in our FAQ).

In addition, all COVID-19 tests marketed in Belgium must comply with Belgian language requirements: all information provided by the manufacturer (instructions for use, leaflet, packaging or any other document accompanying the device) must be drafted in the three national languages (Dutch, French and German). This information may also be provided in English for COVID-19 tests that are solely intended for professional use. Distributors and importers must also check compliance with these language requirements.

More information
•    Belgian IVD manufacturers and Belgian authorised representatives of non-EU IVD manufacturers. 
•    Belgian importers/distributors and other importers/distributors active in Belgium.


Last updated on 31/08/2023