From 10 January 2025, manufacturers face a new, very practical obligation under the MDR and IVDR: informing authorities and the market in advance if the supply of certain devices will be interrupted or discontinued. This duty, introduced via Regulation (EU) 2024/1860 and further explained in a dedicated Q&A and decision tree, is explicitly aimed at protecting patients and public health by giving health systems time to react before critical products disappear from the market.

What does Article 10a actually require?

Article 10a applies to all CE‑marked devices and IVDs (including „legacy devices”), except custom‑made devices, where it is reasonably foreseeable that an interruption or discontinuation of supply could result in serious harm or a risk of serious harm to patients or public health in one or more Member States. The legal obligation rests squarely with the manufacturer, regardless of whether it is established inside or outside the EU, and it cannot be delegated – although authorised representatives and other partners may support the practical execution.

Manufacturers must notify, as a minimum, the competent authority of the Member State where they or their authorised representative are established, and all economic operators, health institutions and healthcare professionals to whom they directly supply the affected device. The information must normally be provided at least six months before the anticipated start of the interruption or permanent discontinuation, unless “exceptional circumstances” make such advance notice impossible.

Interruption vs discontinuation – and what counts as „serious harm”?

The Q&A clarifies that an interruption of supply means a temporary inability or unwillingness to place individual devices of a given model or type on the Union market, typically for more than 60 days. A discontinuation means the manufacturer decides to permanently cease the supply of that model or type. In both cases, the key question is whether the non‑availability of the device may result in serious harm or a risk of serious harm to patients or public health.

Serious harm is linked to situations where patients face an imminent risk of death, a serious deterioration of health, or a life‑threatening condition, and no suitable alternative diagnosis or therapy (including pharmaceutical options) is available. The Q&A offers non‑exhaustive indicators to support the assessment, such as the role of the device in essential healthcare services, the vulnerability of the target population, the availability and readiness of alternatives, and the manufacturer’s market share. A separate decision tree consolidates these considerations into a practical step‑by‑step flow to decide whether notification is required and whether the six‑month rule or the “without undue delay” clause applies.

What does this mean in practice for manufacturers?

Operationally, Article 10a pushes manufacturers to embed early warning and scenario assessment into their supply‑chain, portfolio and lifecycle management. It is no longer sufficient to manage discontinuations as an internal business decision; companies must be able to detect upcoming interruptions, evaluate potential impact on patient care, and trigger structured communication well in advance.

This has several concrete implications:

  • Internal processes and KPIs must be aligned so that decisions on product phase‑out, capacity constraints, or component shortages automatically trigger an Article 10a assessment, using the indicators and decision tree as a reference.
  • Manufacturers need clear responsibility lines for Article 10a notifications and a robust mechanism to collect, maintain and use information on where and to whom each device model is supplied (traceability of upstream and downstream partners).
  • Communication templates should be harmonised with the MDCG Manufacturer Information Form, ensuring that all required elements are covered and that information cascades through economic operators “as is”, without modification or paraphrasing.
  • For mature quality systems, this is less about creating a completely new process and more about tightening the integration between regulatory, supply chain and commercial functions. However, authorities will expect manufacturers to demonstrate that Article 10a has been operationalised – not just acknowledged on paper