2 docs tagged with "nca"

Regulatory basis - MDR Art. 93–97 / IVDR Art. 88–92. National competent authorities have broad powers to investigate, restrict, and remove medical devices from the EU market. The European Commission can intervene at EU level where national actions are insufficient.

Regulatory basis - MDR Art. 87 / IVDR Art. 82 require reports to be submitted to the NCA of the member state(s) where the incident occurred. EUDAMED is the primary reporting platform; some NCAs also accept or require national-format reports.