---
title: "Revision of Q&A on Supply Interruption/Discontinuation Under Article 10a MDR/IVDR"
description: "On 01 April 2026, Revision 2 of the Q&A on the obligation to inform in case of interruption or discontinuation of supply under Article 10a MDR/IVDR, introduced by Regulation (EU) 2024/1860, was published. The update strengthens the link between the Q&A and the Article 10a Decision Tree to support consistent assessments of supply disruptions."
url: https://qbdgroup.com/zh-cn/regulatory-updates/revision-qa-supply-interruption-discontinuation-article-10a-mdr-ivdr
type: "Regulatory update"
language: zh-cn
published: 2026-04-01
author: "Kirsten Van Garsse"
category: "Regulatory Update"
publisher: "QbD Group"
citation: "QbD Group, \"Revision of Q&A on Supply Interruption/Discontinuation Under Article 10a MDR/IVDR\", https://qbdgroup.com/zh-cn/regulatory-updates/revision-qa-supply-interruption-discontinuation-article-10a-mdr-ivdr"
---
# Revision of Q&A on Supply Interruption/Discontinuation Under Article 10a MDR/IVDR
> On 01 April 2026, Revision 2 of the Q&A on the obligation to inform in case of interruption or discontinuation of supply under Article 10a MDR/IVDR, introduced by Regulation (EU) 2024/1860, was published. The update strengthens the link between the Q&A and the Article 10a Decision Tree to support consistent assessments of supply disruptions.

On 01 April 2026, Revision 2 of the [Q&A on the obligation to inform in case of interruption or discontinuation of supply under Article 10a MDR/IVDR, introduced by Regulation (EU) 2024/1860](https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en?filename=mdr_qna-article10a_mdr-ivdr_en.pdf) was published. The update provides a targeted clarification to support the practical implementation of manufacturers' notification obligations in case of supply disruptions.

The main change in Rev. 2 strengthens the link between the Q&A and the [Article 10a Decision Tree](https://health.ec.europa.eu/document/download/c6032b3e-a8c6-4be5-9d61-ce6a7e4ce355_en?filename=md_art10a_decision-tree_en.pdf) developed by competent authorities, **clarifying that the assessment of whether a supply interruption or discontinuation may result in serious harm (Question 9.2) is now explicitly complemented by this tool.** The decision tree supports manufacturers with a structured approach to evaluate key criteria such as duration of the interruption, availability of alternatives, stock levels, and potential impact on patient health.

While the regulatory obligations remain unchanged, the update enhances the operational interpretation and consistency of Article 10a assessments by linking guidance with a practical decision-making aid developed under CAMD.

## What does this mean for you?

For manufacturers, **this update reinforces the need for a clear and well-documented process to assess supply interruptions under Article 10a.** While requirements are unchanged, competent authorities now expect more structured and consistent decision-making, supported by factors such as duration, stock levels, alternatives, and patient impact.

In practice, manufacturers should ensure they can justify and document their assessments, with defined processes for early identification, clear responsibilities, and timely communication to authorities and the supply chain.
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Source: https://qbdgroup.com/zh-cn/regulatory-updates/revision-qa-supply-interruption-discontinuation-article-10a-mdr-ivdr — © QbD Group. Quote freely with attribution and a link back.