Contact person for the Icelandic competent authority (IMA).
With the role of the main PRRC to ensure that:
a) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
b) the post-market surveillance obligations are complied with (Art.10);
c) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
d) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is going to be issued.
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HALLDÓRSDÓTTIR Anna María
Partial role of PRRC to ensure 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.