Field safety notice

The notice has to tell users clearly what the problem is and what they must do. Manufacturers normally share the draft with the competent authority before sending it, unless the situation is urgent.

‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;

EU MDR, Article 2(69)

‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;

IVDR, Article 2(72)