Arrêté royal interdisant la mise à disposition, la mise en service et l'utilisation des tests rapides de mesure ou de détection des anticorps liés au virus SARS-CoV-2, de 17 mars 2020
Article 1er. Pour l'application du présent arrêté, on entend par :
1)" Dispositif médical de diagnostic in vitro " : tout dispositif visé à l'article 1, § 2, 2°, de l'arrêté royal du 14 novembre 2001 relatif aux dispositifs médicaux de diagnostic in vitro;
2) " Test rapide de mesure ou détection d'anticorps liés au SARS-CoV-2 " : groupe de dispositifs médicaux de diagnostic in vitro permettant une mesure ou une détection rapide des anticorps liés au SARS-CoV-2, tels que les IgG, IgM et IgA.
Art. 2. La mise à disposition sur le marché, la mise en service et l'utilisation des autotests rapides de mesure ou détection d'anticorps liés au SARS-CoV-2 sont interdites pour une période de six mois commençant le jour suivant l'entrée en vigueur de la présente décision.
Art. 3. Le présent arrêté entre en vigueur le jour de sa publication au Moniteur belge.
Art. 4. Le ministre qui a la Santé publique dans ses attributions est chargé de l'exécution du présent arrêté.
Signatures
Donné à Bruxelles, le 17 mars 2020.
PHILIPPE
Par le Roi :
La Ministre de la santé publique
M. DE BLOCK
Préambule
PHILIPPE, Roi des Belges,
A tous, présents et à venir, Salut.
Vu la directive 98/79/CE du Parlement européen et du Conseil du 27 octobre 1998 relative aux dispositifs médicaux de diagnostic in vitro, article 13;
Vu la loi du 25 mars 1964 sur les médicaments, articles 1bis, § 3; et 12septies;
Vu l'arrêté royal du 14 novembre 2001 relatif aux dispositifs médicaux de diagnostic in vitro, article 2/1;
Vu les lois sur le Conseil d'Etat, coordonnées le 12 janvier 1973, notamment l'article 3, § 1er, remplacé par la loi du 4 juillet 1989 et modifié par la loi du 4 août 1996;
Vu l'urgence motivée par le fait que la mesure interdisant temporairement la mise à disposition et l'utilisation de certains...
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