Officers and regulatory representatives of PLAN 1 HEALTH S.r.l.
GIORGINI LUCA
“(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;”
“(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.”
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MOROCUTTI NICOLA
MDR 2017/745 Article 15
(a) the conformity of the devices is appropriately checked.....;”
“(b) the technical documentation and the EU declaration of conformity are drawn up.....”
“(c) the post-market surveillance obligations are complied............;”
“(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;”
“(e) in the case of investigational devices, the statement ......is issued”