Officers and regulatory representatives of MEDBRYT
TAFF Michal
PRRC is responsible for ensuring that:
a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
d) the reporting obligations referred to in Articles 87 to 91 are fulfilled