EU IVDR Supply Interruption Notification under Article 10a: Six-Month Advance Notice

1. Key takeaways

Article 10a was inserted into Regulation (EU) 2017/746 by Regulation (EU) 2024/1860 and applies from 2025-01-10. Where a manufacturer anticipates an interruption or discontinuation of the supply of a device, other than a custom-made device, which it can reasonably foresee may lead to serious harm or a risk of serious harm to patients or public health in one or more Member States, it must inform the competent authorities of the Member States concerned and the economic operators and healthcare institutions and healthcare professionals that it directly supplies, at least 6 months before the anticipated interruption or discontinuation, unless there are special circumstances. The obligation is one of information, not of prohibition: supply may still be interrupted, but the regulated notification gives health systems time to secure alternatives before patients are affected. Companies should read the provision as an early-warning mechanism designed to protect continuity of care, and structure their internal processes accordingly rather than treating it as a one-off communications exercise.

2. Legal basis

3. Expert insights

Insight 1: Only the manufacturer bears the obligation, and legal responsibility cannot be delegated.

According to the official Commission Q&A, the notification obligation rests with the manufacturer alone, whether established inside or outside the EU; the manufacturer may not delegate the legal responsibility for the task, although it may seek practical assistance in performing it from its authorised representative, other economic operators or third parties. Economic operators and healthcare institutions that receive the notification must relay the information down the supply chain to the relevant healthcare institutions or healthcare professionals without altering, adding to or removing any content. In practice this cascading duty means the quality and clarity of the original notification text matter enormously, because downstream recipients transmit it verbatim. A notification that is ambiguous in the original cannot be repaired downstream, so the manufacturer should prepare and quality-check the wording before it leaves the company.

Insight 2: The decisive test is whether serious harm is reasonably foreseeable, not simply whether a stock-out occurs.

The Commission Q&A identifies the factors to be weighed: the importance of the product to essential medical care, the degree to which patient health and safety depend on continued supply, the availability of suitable alternative products on the market, and the anticipated duration of the interruption, existing inventories and the replenishment lead time of alternative products. The threshold is deliberately not tied to commercial volume: a niche reagent used by a small number of laboratories may carry a high notification risk if no substitute exists. Companies therefore need an internal mechanism that can support and document this judgement product by product. The assessment should combine input from regulatory affairs, supply chain, quality and commercial teams, since none of these functions alone holds all the facts the test requires.

Insight 3: The obligation has a clear temporal boundary of application.

According to the Commission Q&A, Article 10a applies from 2025-01-10. Where the manufacturer anticipated the interruption or discontinuation to occur before 2025-01-10, there is no mandatory reporting obligation even if the interruption in fact occurs after that date (the Commission encourages voluntary notification in such cases). This boundary is defined by the relevant provisions of Regulation (EU) 2024/1860. Compliance programmes should therefore anchor assessments to the anticipated date of the interruption as known to the manufacturer, not to the date the interruption materialises.

Insight 4: The April 2026 Q&A revision provides an official decision tree.

In April 2026 the Commission published a revised Q&A (Rev.2) together with a decision tree on the assessment of serious harm developed by the working group of competent authorities. This gives manufacturers an officially recognised, standardised tool for deciding whether an anticipated supply interruption or discontinuation triggers Article 10a. The earlier practical difficulty, namely that assessments lacked an agreed basis and judgements lacked an agreed standard, is thereby substantially eased. Companies should adopt the decision tree directly in their procedures and retain the completed assessment as compliance evidence, since the tree now provides the reference point against which any authority reviewing the company’s judgement will assess it.

4. Practical recommendations

1. Maintain a supply continuity register covering critical raw materials, production lines, critical suppliers, regional inventories and alternative procurement lead times for every device placed on the EU market.
2. Run the serious harm assessment using the official Commission decision tree, and retain the completed assessment records and conclusions as documentation.
3. Build a notification target list for each product: the economic operators, healthcare institutions and healthcare professionals directly supplied, plus the competent authorities of the Member States where the authorised representative is established.
4. Embed the downstream information relay duty into supply chain contracts, making clear that recipients may not alter, add to or interpret the notification content.
5. Link the assessment to Article 110 transition decisions: when a product line is to be exited, start the Article 10a evaluation at the same time so the 6-month clock is respected.

5. Verification checklist

• □ The obligation holder is confirmed as the manufacturer, whether or not established in the EU
• □ The temporal boundary of application from 2025-01-10 is documented
• □ The serious harm / risk assessment uses the official decision tree and records are retained
• □ A notification target list (economic operators, healthcare institutions, healthcare professionals, competent authorities) is established
• □ A scheduling mechanism for the at least 6 months advance notification is in place
• □ The downstream information relay duty is written into supply chain contracts

Legal information verified as of 29 October 2026.

GRZAN assists IVD manufacturers supplying the EU market with supply continuity compliance under Article 10a: building the supply continuity register, running serious harm assessments with the Commission decision tree, preparing and cascading notifications to competent authorities and direct customers, and integrating Article 10a reviews with legacy device transition decisions. For support with supply interruption notifications, contact info@grzanglobal.com.