Dirigeants et représentants réglementaires de ALPA, a.s.
NOVOTNÝ Václav
the conformity of the MDs is appropriately checked, in accordance with the QMS under which the MDs are manufactured, before an MD is released; the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; the PMS obligations are complied with in accordance with Art.10(10) MDR; the reporting obligations referred to in Art.87–91 MDR are fulfilled; in the case of investigational MDs, the statement referred to in Section 4.1 of Annex XV MDR is issued.