2 docs tagged with "field-safety"

Regulatory basis - MDR Art. 89 and Art. 95 / IVDR Art. 84 and Art. 90. EU medical device recalls are a subset of FSCAs. Unlike some other regulatory systems, the EU does not have a single standardised recall classification system — instead, the risk assessment under ISO 14971 and NCA discretion determine the urgency and scope.

Regulatory basis - MDR Art. 2(68) and Art. 89 / IVDR Art. 2(70) and Art. 84. An FSCA is any corrective action taken by a manufacturer to reduce a risk of death or serious deterioration in health associated with a device already placed on the market. FSCAs must be notified to NCAs.