MDR/IVDR Watch / Archive
Article 10a decision tree published on supply interruption and discontinuation notifications
Published 01 Apr 2026
The Commission published a decision tree (dated 1 April 2026) to help manufacturers assess whether a supply interruption or discontinuation of a device falls under the Article 10a information obligation introduced by Regulation (EU) 2024/1860. It covers interruptions expected to last more than 60 days, discontinuations, and notifications to the competent authority and affected customers, with notice due at least 6 months ahead where applicable, or without undue delay for imminent-risk cases.
Original title: Article 10a Decision tree
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New MDCG guidance, implementing acts, standards and EUDAMED changes, each explained in two lines: what changed and who must act.
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Published 19 Jan 2026
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