Notification for interruptions or discontinuations in the supply of medical devices

In its recent Regulation (EU) 2024/1860, the European Commission introduced amendments to the Medical Devices Regulations (MDR and IVDR). One of the main novelties of this Regulation is introduced by Article 10a, which outlines the obligations regarding the interruption or discontinuation of supply for certain devices. Following the introduction of 10a, a Q&A document was published by the European Commission to address the practical aspects of its implementation.

Article 10a tackles the situation where a supply of a device to the EU market is not ensured for more than 60 days. However, if the supply of a device is interrupted for a shorter period, but it might result in serious harm or a risk of serious harm to patients or public health, the manufacturer is to follow Article 10a, nevertheless.

Process for anticipated discontinuation of device supply

The procedure starts with the manufacturer. If an interruption or discontinuation in the supply of a medical device or IVD is anticipated, which could result in serious harm or pose a risk to patients, the manufacturer must notify the competent authority of the Member State where they or their authorised representative is established at least six months before the end of supply, providing the reasons for this decision. The authorised representative can support the manufacturer when notifying the competent authority.

Additionally, the manufacturer must inform the economic operators, health institutions, and healthcare professionals to whom it supplies the device directly.

Once the manufacturer has notified the relevant actors, the competent authority that has received the notice will inform the competent authorities of the other Member States and the European Commission of the interruption or discontinuation. Similarly, the economic operators who have received the notification will alert any other economic operators, health institutions and healthcare professionals to whom they provide the device directly.

Example from the Commission Q&A

Example of the onward information sharing in the context of a supply interruption where the manufacturer does not directly supply to the health institution:

On 1 May 2025, a manufacturer of a CE-marked pacemaker confirms that a supply interruption is expected to begin in approximately seven months i.e. 1 December 2025. The manufacturer, located outside of the Union, does not supply the pacemakers directly to health institutions (HIs). Instead, the devices are supplied to importers, who then supply them to a network of distributors that ultimately deliver them to HIs across several Member States. In this case, the information flow should proceed as follows:

1. Initial manufacturer information obligation: by 1 June 2025, i.e. at least six months before the confirmed anticipated start of the supply interruption on 1 December 2025, the manufacturer must inform the competent authority in the Member State where its authorised representative is established, as well as the importers to whom it supplied the device in question.
2. Downstream information flow:
   • Importers: Upon receiving this information from the manufacturer, the importers of the device in question must, without undue delay, transmit the information, as provided by the manufacturer, to all distributors to whom they directly supply.
   • Distributors: When receiving the information from the importers, distributors must without undue delay, relay it, as provided by the manufacturer to any other distributors to whom they supply the device in question as well as the HI they supply (Source: European Commission).

The Q&A document provides further clarifications on what is considered to be an “interruption or discontinuation that may result in serious harm or a risk of serious harm to patients or public health”, and how the manufacturer should approach such an assessment. Additionally, the Q&A addresses situations where the manufacturer is exempted from the notification obligation and explains the obligations of different economic operators.

European Commission’s aim to protect the EU medical device supply

The objective of the Commission is to ensure timely communication among manufacturers, competent authorities, and economic operators regarding any anticipated changes in the supply of medical devices and IVDs. With this, the new procedure aims at protecting patients from supply interruptions and at preventing market disruptions caused by medical devices whose lack of supply can cause risk or harm.

Do you have any questions regarding the new procedure on the interruption or discontinuation of supply for certain medical devices? Do not hesitate to contact us!