Translated with AI.

On 1 April 2026, the European Commission published the Article 10a Decision Tree and Revision 2 of the FAQs on notification of interruption and discontinuation of supply.

These tools help manufacturers and authorised representatives determine when a disruption in the supply of a medical device falls within the scope of Article 10a of the MDR and IVDR Regulations and require formal notification to the relevant competent authorities.

In particular, the Decision Tree supports a structured assessment of whether a situation constitutes an interruption of supply or a discontinuation of supply with a potential impact on the availability of the device on the Union market.

The objective is to ensure a high level of public health protection, enabling authorities and healthcare institutions to adopt timely mitigation measures.

Notification obligation under Article 10a

Introduced by Regulation (EU) 2024/1860 and applicable as of 10 January 2025, Article 10a requires manufacturers to inform the competent authorities of the Member State in which they are established (or where the authorised representative is established), as well as the economic operators and healthcare professionals to whom they directly supply the device, in the event of interruption or discontinuation of supply of a medical device.

For the purposes of the Regulation, the following fall within the scope of the obligation:

  • Interruption of supply: temporary inability to place devices of a given model or type on the market.
  • Discontinuation of supply: permanent cessation of placing the model or type of device on the market.

For practical purposes, an interruption may be considered as such, on a preliminary basis, when it exceeds 60 days.

The obligation applies only where such events are reasonably foreseeable as likely to cause serious harm to public health or patients, i.e. situations involving risk of death, serious deterioration of health, or life-threatening conditions, particularly in the absence of suitable alternatives.

The notification responsibility remains with the manufacturer, even where third parties are used for operational tasks.

Key points of Article 10a

  • Scope: applies to all device models or types, including legacy devices, except custom-made devices, where the interruption or discontinuation is reasonably foreseeable as capable of causing a risk of serious harm to patients or public health.
  • Risk threshold: notification is required where serious harm is reasonably foreseeable (risk of death, serious deterioration of health, or life-threatening conditions), particularly in the absence of suitable alternatives.
  • Standard timelines: notification must be submitted at least 6 months before the expected event.
  • Exceptional circumstances: in case of sudden and unforeseeable events (e.g. natural disasters, raw material shortages), notification must be made without undue delay.

The Decision Tree: risk assessment guidance

The Decision Tree provides a logical pathway to support the assessment of whether there is a foreseeable risk of serious harm:

  1. Stock analysis: availability of inventory may help exclude or reduce the foreseeability of a critical shortage within the relevant period.
  2. Availability of alternatives: the presence of suitable alternative devices is a relevant factor in the risk assessment but does not automatically exclude the notification obligation.
  3. Harm assessment: if the interruption may cause a risk of imminent death or serious deterioration of health, notification is required regardless of the expected duration.

What’s new in FAQ Revision 2

The update introduces more structured elements to support the assessment:

  • Public health relevance: attention to life-saving devices or those intended for vulnerable populations (paediatric or geriatric patients).
  • Market and availability factors: consideration of supply volumes, access to alternatives, and continuity of device availability.

Manufacturer Information Form (MIF)

For operational compliance, manufacturers must use the Manufacturer Information Form (MIF), a standardised template that ensures consistent communication of the reasons for interruption to competent authorities.

Once the initial communication has been issued by the manufacturer, distributors and importers must forward it to their customers without undue delay and without altering its content.

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