Interruption of supply

Under Article 10a of the MDR and IVDR, an anticipated interruption can trigger advance notice when it could result in serious harm or risk of serious harm. The Q&A explains which situations count, to keep the obligation workable in practice.

An “interruption of supply” should be understood as the consequence of a manufacturer confirming that they cannot or are unwilling to operate as previously intended or planned in relation to the supply of a device, which can lead to a temporary disruption of supply. With the view to making the application of the Article 10a information obligation workable in practice and to avoid unnecessary reporting, an interruption of supply should be understood as having a temporary inability to place individual devices of a given model or type on the Union market, with an expected duration of more than 60 days, as a general indication. However, this should not prevent the manufacturer from notifying of a supply interruption lasting less than 60 days if they assess that this may result in serious harm or a risk of serious harm to patients or public health.

Q&A on the Article 10a obligation in case of interruption or discontinuation of supply (Regulation (EU) 2024/1860), rev.2, Question 7