Supply Interruption Notification Under MDR Article 10a

1. Key takeaways

Under Article 10a of the MDR (inserted by Regulation (EU) 2024/1860, applicable from 2025-01-10), where a manufacturer foresees an interruption or discontinuation of the supply of a device (custom-made devices excepted) that could reasonably be expected to result in serious harm or a serious risk of harm in one or more Member States, it must inform the competent authorities of the Member States in which it or its authorised representative is established, as well as the economic operators, healthcare institutions and healthcare professionals it supplies directly. Except where special circumstances apply, the information must be provided at least 6 months before the foreseen interruption or discontinuation. The duty operates as a three-layer chain: the manufacturer informs the competent authorities, the authorities inform the other Member States and the Commission without undue delay, and the economic operators receiving the information pass it on without undue delay to those they supply directly. Legacy devices are covered too, through Article 120(13), so phasing out products certified under the old directives requires the same notification. Many companies have not yet embedded this obligation in their procedures because it is new to the MDR era, which makes it a priority gap to close.

2. Legal basis

The obligation, its applicability date and its scope are established by the following instruments and guidance.

3. Expert insights

Insight one: this is a new, standalone obligation added after the MDR came into force, and many companies have not yet embedded it in their processes.

Article 10a is not part of Article 10; it is a provision inserted in full by Regulation (EU) 2024/1860 (adopted 2024-06-13, in force 2024-07-09), applicable from 2025-01-10 pursuant to Article 3 of that regulation. The legislative background is the prevention of public health crises arising from shortages of in vitro diagnostic devices and other critical devices. Because the obligation arrived after the original MDR implementation wave, quality management systems built before 2024 often contain no trigger for it, and internal procedures should be updated deliberately rather than waiting for a first real shortage event to test them.

Insight two: the notification chain has three layers; informing the competent authority is not the end of the duty.

The first layer: the manufacturer informs the competent authorities of the Member State in which it or its authorised representative is established, stating the reasons for the interruption or discontinuation. The second layer: the competent authorities inform the competent authorities of the other Member States and the Commission without undue delay. The third layer: the economic operators in the supply chain that receive the information pass it on without undue delay to the economic operators, healthcare institutions and healthcare professionals they supply directly. The three-layer chain means a single company may be both a notifier and a forwarder: a distributor that receives a discontinuation notice from an importer must relay it downstream on its own account, so the duty does not stop at the top of the chain.

Insight three: 6 months is the principle; the exception is special circumstances.

The second subparagraph of Article 10a(1) provides that, except where special circumstances apply, the information must be provided at least 6 months before the foreseen interruption or discontinuation. The Commission Q&A (Rev 1, 2024-12) explains special circumstances as situations where the manufacturer could not foresee or confirm the supply interruption 6 months in advance, for example disasters, the sudden unavailability of raw materials or components, or interruptions arising from unforeseen circumstances including economic or financial reasons. In these situations, the information must be provided without undue delay after becoming aware. The practical reading is that the 6-month rule is the default and that any shorter notice must be justified and documented at the time, not reconstructed later.

Insight four: legacy devices are covered too.

Under Article 120(13) (as amended by (EU) 2024/1860), Article 10a also applies to the legacy devices referred to in Articles 120(3a) and 120(3b). This means that discontinuing a product certified under the old directives also triggers the notification duty; withdrawing an older product from the market is not a ground for exemption. Companies retiring legacy portfolios as certificate validity windows close should therefore run the same trigger assessment and notification workflow for those products as for MDR-certified ones.

4. Practical recommendations

1. Establish a supply interruption / discontinuation trigger assessment table: foreseeability, reasonable foreseeability of serious harm, and the range of affected Member States.
2. Prepare notification templates for each of the three layers: the competent authority version, the downstream economic operator version, and the healthcare institutions and professionals version.
3. Use the MDCG 2024-16 manufacturer information form for the competent authority notification, stating the reasons for the interruption.
4. Maintain a list of direct supply recipients in the supply chain management system, ensuring each can be reached individually.
5. Bring legacy devices into the same process (Article 120(13)).

5. Verification checklist

Confirm the following items to verify the obligation is embedded in your procedures.

• □ A supply interruption / discontinuation trigger assessment table is established
• □ The applicability date of Article 10a (2025-01-10) has been confirmed
• □ The three-layer notification templates are prepared (competent authority, economic operators, healthcare institutions and professionals)
• □ The competent authority notification uses the MDCG 2024-16 information form
• □ The list of direct supply recipients is maintained in the system
• □ Legacy devices are included in the same process (Article 120(13))
• □ The criteria for special circumstances are written into internal procedures (the exception to the 6-month principle)

Regulatory information verified as of 29 October 2026.

GRZAN helps manufacturers implement the Article 10a supply interruption and discontinuation notification regime under the EU MDR, providing EU Authorised Representative (AR) and PRRC services, competent authority notification support using the MDCG 2024-16 information form, downstream notification workflows for economic operators and healthcare institutions, and fee and budget planning for compliance operations. Our team brings legacy devices under Article 120(13) into the same process and keeps companies without an establishment in the European Union inspection-ready under Regulation (EU) 2017/745. For practical support with notification procedures, registration and budget matters, contact GRZAN at info@grzanglobal.com.