Officers and regulatory representatives of LASOTRONIX
POKORA Marcin
Art.15 MDR-PRRC shall be responsible for ensuring that:
a) the conformity of the devices is checked in accordance with the QMS under which the devices are manufactured, before a device is released
b) the TD and the EU DoC are drawn up and kept up-to-date
c) the post-market surveillance obligations are complied with in accordance with Art.10(10)
d) the reporting obligations are fulfilled(Art.87 to 91)
e) in the case of investigational devices the statement is issued (Sec 4.1 of Ch II of An XV)