The European Commission (‘Commission’) has published a Questions & Answers (‘Q&A’) document on the new obligation to notify interruptions or discontinuations of the supply of medical devices under the Medical Devices Regulation (Regulation (EU) 2017/745, ‘MDR’) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’).

This new reporting obligation is set out in the newly introduced Articles 10a in both the IVDR and the MDR, as amended by Regulation (EU) 2024/1860. This obligation will start to apply on 10 January 2025.

Our blog focuses on the key requirements applying to manufacturers, and how these align with  the European Medicines Agency’s (‘EMA’) role to monitor medical device shortages.

Article 10a obligation to notify

Article 10a of the MDR and IVDR requires medical devices manufacturers to notify any supply interruptions or discontinuations of the marketing of their devices when they can reasonably foresee a serious harm or risk to patients’ or public health in an EU Member State. This obligation applies to all manufacturers, whether established in the EU or not, and to all medical devices, including legacy devices. The only exception are custom-made devices.

The Q&A also sets out the key definitions:

• Interruption of supply: It is defined as a temporary inability to place individual devices of a given model or type on the EU market for more than 60 days. Manufacturers are still encouraged to notify even if the interruption lasts less than 60 days if it may result in serious harm or a risk to patient or public health.
• Discontinuation of supply: Discontinuation occurs when the supply of a device ceases entirely, and the individual devices of this model or type are no longer placed on the EU market.

Who must notify whom?

Manufacturers must notify

• The competent authority in the EU Member State where the manufacturer or their authorized representative is established.
• All economic operators, health institutions, and healthcare professionals to whom the manufacturer directly supplies the concerned medical device.

Other economic operators

Economic operators (i.e., importers, distributors) who are notified by manufacturers of the discontinuation/interruption are required to pass on the information received in the downstream supply chain until it reaches the relevant health institutions and healthcare professionals using the medical device in question.

When must manufacturers notify?

Manufacturers must notify at least 6 months before the anticipated interruption/discontinuation of the supply of the medical device, or immediately upon becoming aware in cases of exceptional circumstances.

Examples of exceptional circumstances noted in the Q&A include natural disasters, sudden inability to obtain raw materials or components or unexpected issues of economic nature.

Anticipation of an interruption or discontinuation of device supply

The Q&A acknowledges that an interruption or discontinuation may be caused for several reasons, including certification issues, device performance, access to raw materials or components, business decisions, etc.

When anticipating interruptions/discontinuations, manufacturers are generally not required to consider factors like the availability of stock of alternative devices, the appropriateness of other devices with similar intended purpose, or other manufacturers’ capability to produce sufficient quality or quantity of devices.

Note, however, that according to the Commission’s Q&A, serious harm or risk may occur when there is an imminent risk of death, a serious deterioration of patient health, or a life-threatening condition, and that no suitable alternative diagnosis method or therapy is available. In these cases, it is likely that manufacturers will have to consider the existence of alternative devices from other manufacturers.

No notification is required when manufacturers can replace a medical device impacted by an interruption or discontinuation of supply with a successor device with a similar intended purpose. Neither is notification required when there is sufficient stockpile of the medical device in question or the health institutions and/or healthcare professionals concerned have confirmed to the manufacturer that no serious harm or risk of serious harm to patients or public health would occur in case of interruption or discontinuation of the supply of the medical device in question.

What information must be notified by manufacturers?

Manufacturers must provide the following:

• Information required in the ‘Manufacturer Information Form’: The form is pending publication by the Commission.
• Any additional information required by the relevant Member State: If applicable.
• Voluntary information in the ‘Manufacturer Information Form’: While optional, it is encouraged if it assists authorities in assessing the situation.
• Reasons for the interruption/discontinuation: These may include regulatory issues (e.g., delay in certification of device), manufacturing challenges (e.g., device performance concerns), supply chain disruptions (e.g., shortages) or other factors (e.g., marketing or business reasons).

Manufacturers are expected to analyse the problem or business decision, evaluate mitigation measures across operations and the supply chain, and develop appropriate communication strategies for stakeholders. Although the guidance does not specify whether you must provide details of this analysis, we advise documenting it.

EMA’s role to monitor medical device shortages

The obligation to notify supply interruptions/discontinuations under the MDR and IVDR applies in parallel with EMA’s mandate to monitor shortages of medical devices. Manufacturers will be, therefore, subject to both regulatory regimes. However, EMA is responsible only for the devices listed as ‘critical medical devices’ during a public health emergency. When a manufacturer markets such critical medical devices during a public health emergency, a number of obligations apply, including the requirement to provide information to the EMA under Article 26 of the Regulation (EU) 2022/123. This information, requested by the EMA, supports the EMA’s Medical Device Shortages Steering Group (‘MDSSG’) in monitoring shortages of listed critical devices.

When does the obligation to notify supply interruptions and discontinuations take effect?

The obligation to notify takes effect on 10 January 2025, though early voluntary compliance is encouraged to align with best practices. To ensure timely notification, the Commission recommends manufacturers to establish adequate processes and monitoring systems.