When an FSCA is required
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.
Field safety notices (FSNs)
Regulatory basis - MDR Art. 89(3) / IVDR Art. 84(3). A field safety notice (FSN) is the communication issued by a manufacturer to inform customers, distributors, and users of an FSCA and what action they need to take. MDCG 2023-3 provides a template.
Recalls — classification & coordination
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.
Competent authority-initiated actions
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.