2 docs tagged with "market-surveillance"

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. 93–97 / IVDR Art. 88–92. Market surveillance is the system of NCA activities that ensures devices on the EU market comply with MDR/IVDR requirements. It is distinct from — but complementary to — the manufacturer's own post-market surveillance system.