Discontinuation of supply

Article 10a, added to the MDR and IVDR by Regulation (EU) 2024/1860, requires advance notice when a manufacturer anticipates an interruption or discontinuation that could result in serious harm or risk of serious harm to patients or public health. The Q&A ties discontinuation to the whole Union market, not to a single customer or country.

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 Union market.

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