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Healthcare: Medical device and in vitro diagnostic medical device supply shortages – Decree No. 2026-730 of August 1, 2026, details the mechanism.
22/09/2026 , 10h11
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If you only have 30 seconds…
The decree establishes the implementing rules for the French system aimed at preventing shortages of medical devices (MDs) and in vitro diagnostic medical devices (IVDs), introduced by Article 10a of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), and by the DDADUE Law of 30 April 2025. It specifies the content and means of notification in the event of an interruption or discontinuation of supply, establishes the adversarial procedure to be followed before the ANSM adopts health police measures, and requires responses within eight days, reduced to 24 hours in emergencies. Breaches of these obligations may result in a financial penalty of up to 50% of the turnover generated by the product concerned, capped at €5 million.
The legal framework: a two-pronged system
The European framework
Regulation (EU) 2024/1860 of 13 June 2024 introduced Article 10a into the MDR and the IVDR, applicable since 10 January 2025. Where a manufacturer anticipates an interruption or discontinuation of supply of a device, excluding custom-made devices in the case of MDs, and it is reasonably foreseeable that this may cause serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer must notify the competent authority of the Member State in which it is established, or in which its authorised representative is established, as well as the economic operators, healthcare institutions and healthcare professionals to whom it directly supplies the device. Unless exceptional circumstances apply, this notification must be made at least six months before the anticipated interruption and must specify the reasons for it to the competent authority. Economic operators receiving such notification must, without undue delay, relay the information further down the supply chain.
The national framework
Law No. 2025-391 of 30 April 2025 introduced Articles L. 5215-1 A (MDs) and L. 5224-1 (IVDs) into the French Public Health Code. Where the ANSM has been notified pursuant to Article 10a and considers that the interruption may cause serious harm or a risk of serious harm, it shall take measures that are strictly necessary and proportionate to ensure continuity of patient care. In this respect, it shall publish the information on its website (1°), may issue recommendations, including on alternative solutions (2°), and may subject the device to specific conditions, restrict or suspend its operation, export, wholesale distribution, packaging, placing on the market, storage for sale, advertising, putting into service, prescription, dispensing or use (3°).
The decree under review creates Chapter V in Title I (Articles R. 5215-1 to R. 5215-3, MDs) and Chapter IV in Title II (Articles R. 5224-1 to R. 5224-3, IVDs) of Book II of Part Five of the French Public Health Code.
The implementing rules set out in the decree
1. Scope of the MDs and IVDs concerned
Articles L. 5215-1 A and L. 5224-1 of the French Public Health Code refer to “devices referred to in Article 1” of the MDR and the IVDR. The system therefore covers all MDs and their accessories, across all classes (I to III), as well as all IVDs (classes A to D), with no regulatory criticality threshold.
The obligation is triggered only where it is reasonably foreseeable that the interruption or discontinuation may cause serious harm or a risk of serious harm to patients or public health in one or more Member States. The assessment is left to the manufacturer, subject to subsequent review by the competent authority.
Recital 15 of Regulation (EU) 2024/1860 identifies relevant factors: the importance of the device in ensuring essential healthcare services, the extent to which patient safety depends on its continued availability, and the absence of suitable alternatives. This assessment takes into account the expected duration of the interruption, the quantities already made available, available stocks and the lead times for obtaining substitute solutions. The European Commission has also published a Q&A addressing practical aspects of implementing the obligation under Article 10a in the event of an interruption or discontinuation of the supply of certain devices, as well as form MDCG 2024-16.
2. Notification requirements (Articles R. 5215-1 and R. 5224-1 of the French Public Health Code)
Notifications must be made through two separate channels:
- To the ANSM, electronically, in accordance with procedures to be established by a decision of the Agency’s Director General;
- To economic operators, healthcare institutions and healthcare professionals, by any means allowing receipt to be acknowledged. The required information includes the device’s name, class, intended purpose and trade name, the manufacturer’s name, and the reasons for and estimated duration of the interruption or discontinuation.
The procedure
1. The obligation to respond to ANSM requests for information (Articles R. 5215-3 and R. 5224-3)
The manufacturer or, where applicable, its authorised representative must respond within eight days, reduced to 24 hours in an emergency, to requests for information made by the Agency pursuant to the final paragraph of Articles L. 5215-1 A and L. 5224-1 of the French Public Health Code.
2. The prior adversarial procedure (Articles R. 5215-2 and R. 5224-2 of the French Public Health Code)
As mentioned above, the Director General of the ANSM may adopt decisions imposing specific conditions on, restricting or suspending the operation, export, wholesale distribution, packaging, placing on the market, storage for sale, advertising, putting into service, prescription, dispensing or use of the device, pursuant to point 3° of Articles L. 5215-1 A and L. 5224-1 of the French Public Health Code. Before doing so, the Director General must give the party concerned the opportunity to submit written observations and, at their request, oral observations, while informing them of their right to be assisted by counsel.
The period granted may not be shorter than eight days and is reduced to 24 hours in an emergency. Decisions are published on the Agency’s website.
In both cases, the concept of an emergency is not defined, and the decision to reduce the period to 24 hours is left to the Agency’s discretion.
Substantial financial penalties
The system includes an enforcement component that has been in force since 3 May 2025. The decree makes the penalties fully operational in the following cases:
- For manufacturers established in France or whose authorised representative is established in France: failure to provide notification under Article 10a(1), failure to comply with measures adopted by the ANSM pursuant to point 3°, and failure to respond to requests for information (French Public Health Code, Article L. 5461-9, point 24° for MDs; Article L. 5462-8, point 20° for IVDs);
- For economic operators: failure to relay the information further down the supply chain pursuant to Article 10a(3) (Article L. 5461-9, point 25°; Article L. 5462-8, point 21°).
The maximum financial penalty is set out in Article L. 5471-1, III, of the French Public Health Code: €150,000 for an individual and, for a legal entity, 50% of the turnover generated during the last completed financial year by the product or group of products concerned, capped at €5 million. A daily penalty payment of up to €2,500 may also be imposed, and penalty decisions are published on the ANSM’s website for one year.
