Article 10a Decison Tree

‍Article 10a of the MDR governs obligations imposed on manufacturers and the competent authorities of EU Member States in case of interruption or discontinuation of supply of certain devices. The European Commission has developed an Article 10a Decision tree.

The purpose of the Decision tree is to provide support to manufacturers in determining the circumstances in which notification to competent national authorities is required.

The table includes definitions of “interruption of supply” and “discontinuation of supply”‍‍ ‍

• 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 EU 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.

• A “discontinuation of supply” should be understood to include when a manufacturer can confirm that it will cease the supply of a device and therefore no longer places the individual devices of this model or type on the EU.