Ministerieel besluit houdende de delegatie van handtekening met betrekking tot de toelating tot het in de handel brengen of in gebruik nemen van medische hulpmiddelen, de 2 mars 2021
Artikel 1. Aan de Administrateur-generaal van het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (hierna: FAGG) wordt delegatie van handtekening verleend voor de toelatingen voor het in de handel brengen of de ingebruikneming van medische hulpmiddelen, overeenkomstig artikel 59 van de Verordening (EU) 2017/745 van het Europees Parlement en de Raad van 5 april 2017 betreffende medische hulpmiddelen, tot wijziging van Richtlijn 2001/83/EG, Verordening (EG) nr. 178/2002 en Verordening (EG) nr. 1223/2009, en tot intrekking van Richtlijnen 90/385/EEG en 93/42/EEG van de Raad alsook zonder dat de in artikel 52 van voornoemde Verordening bedoelde procedures zijn uitgevoerd, maar waarvan het gebruik in het belang van de volksgezondheid, of de veiligheid of gezondheid van de patiënten is.
Art. 2. De Administrateur-generaal van het FAGG brengt om de drie maanden verslag uit aan de Minister van Volksgezondheid van de toelatingen die middels deze delegatie werden ondertekend.
Handtekening
Brussel, 2 maart 2021.
Fr. VANDENBROUCKE
Aanh...
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