COVID self-tests in Belgium: Conditions and approval process

From April 4, 2021, rapid antigen self-tests are allowed for sales in Belgian pharmacies! However, only if they respect strict conditions set out and verified by the Belgian Competent Authority FAMHP.

Currently, there is only 1 SARS-CoV-2 antigen self-test with a CE Certificate, thus, compliant tests for professional use are exceptionally granted access to the Belgian market via a derogation procedure available until 7 May 2021.

Which are the conditions?

  • Rapid test is listed in the ‘liste des tests rapides d’antigènes recommandés’ by the FAMHP (performance criteria) ;
  • Self-test is undergoing certification by a Notified Body intended as self-test ;
  • Test conforms to IVDD essential requirements for self-testing devices, except for the requirement related to a Notified Body certificate ;
  • IFU and labelling are available in Dutch, French and German language ;
  • Only nasal and oropharyngeal swab procedure is allowed. For ex. devices with saliva based specimen are not allowed ;
  • Test needs to have minimal sensitivity of 95% with high viral load (Ct ≤  25) based on at least 3 independant evaluations ;
  • Test needs to be a standalone one, with no additional devices needed ;
  • Test contains everything necessary to collect and analyze the specimen, as well as to interpret the result ;
  • The box destined to the final user shall contain no more than 10 tests and the components shall be individually available. For ex. 1 diluent for each cassette ;
  • Self-test usage is clearly visible on the packaging. For ex. a sticker can be added to the packaging to differentiate between tests for professional use and self-tests.

Which documents are needed?

  • Declaration of Conformity in accordance with Annex II of the IVDD;
  • IFU as well as labels in Dutch, French and German language for self-test usage;
  • Signed contract with the Notified Body that will asses the self-test, or a declaration that a pre-application was submitted to a Notified Body;
  • Roadmap with established timeline on the receipt of the Notified Body Certificate;
  • List describing control over essential requirements of IVDD and applicable harmonized standards;
  • Document describing the differences between CE-marked rapid test included in the FAMHP list and the self-test in question;
  • 3 independent evaluations proving the sensibility of at least 95% in a sample value Ct ≤ 25;
  • Validation study: clinical validation demonstrating self-test performance without supervision (sensibility and specificity);
  • Document showing that the test detects the most common variants, including     VOC202012/01 (British variant), 501 Y.V2 (South-African variant) et P.1 (Brazilian variant);
  • Specific analysis on the risks of using the test as self-test;
  • If applicable, proof of the self-test being authorized by any other EU Member State;
  • Signed declaration where the manufacturer accepts the conditions of the derogation and the obligation to keep a post-market surveillance system in place, while all incident and corrective measures are to be reported to the FAMHP in accordance with the Materiovigilance legal requirements;
  • Designation letter, in case another entity requests the derogation on behalf of the manufacturer.

In case the application is successful, the derogation granted to the manufacturer is valid until September 1, 2021, or until the manufacturer has obtained the CE Certificate from its Notified Body. On the contrary, in case the device presents a risk to public health, the derogation clause can be revoked!

All SARS-CoV-2 antigen tests for professional use that are approved by the FAMHP to be sold as self-tests to private individuals in pharmacies are added to the publicly accessible list.


Ajda Mihelcic

DPM Publications department

19.04.2021

Update: 30.04.2021


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References:

  • AFMPS. (2021). Procédure exceptionnelle à destination des fabricants afin de pouvoir commercialiser des tests rapides d'antigènes SARS-CoV-2 à usage professionnel en tant qu'autotest en Belgique. Retrieved on 19.04.2021 from https://www.afmps.be/fr/usage_humain/produits_de_sante/dispositifs_medicaux_et_leurs_accessoires/covid_19/tests/procedure
  • AFMPS.(2021). Tests rapides professionnels autorisés à la vente en tant qu'autotest. Retrieved on 19.04.2021 from https://www.afmps.be/fr/tests_rapides_professionnels_autorises_a_la_vente_en_tant_quautotest