Serious harm or risk of serious harm to patients or public health

Article 10a requires manufacturers to give advance notice when they expect to interrupt or discontinue supply of a device and this could cause such harm. Whether the threshold is met has to be assessed device by device, considering the alternatives available to patients.

“Serious harm or risk of serious harm to patients or public health” should be understood as any serious injury to patients or threat to public health that occurs, or where there is a significant probability of this occurring.

Q&A on the Article 10a obligation in case of interruption or discontinuation of supply (Regulation (EU) 2024/1860), rev.2, Question 8