Medical device availability

Economic operators' roles and responsibilities

Manufacturers

Manufacturers must provide the information at least six months before the anticipated interruption or discontinuation of the supply of certain MDs and IVDs, save in exceptional circumstances (e.g. natural disasters or sudden shortages of raw materials). However, it is recommended that they provide the information sooner, if possible:

  • An interruption of supply is defined as a manufacturer's temporary inability to supply a device lasting more than 60 days.
  • A discontinuation of supply means that the manufacturer will no longer place the device on the market in the European Union.

The information obligation applies only to MDs and IVDs for which it is reasonably foreseeable that the interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States.

'Serious harm or risk of serious harm to patients or public health' should be understood to mean any serious injury to patients or any threat to public health that occurs, or where there is a significant probability of this occurring.

Before providing the information, the manufacturer must assess the impact of the interruption or discontinuation in the supply of the MDs and IVDs, taking into consideration the potential consequences of the non-availability on patient treatments or diagnosis methods. Indeed, in some cases, the non-availability of MDs and IVDs may result in an imminent risk of death, a serious deterioration in patient health, or life-threatening conditions for patients, when no suitable alternatives are available. For further details, please refer to the MDCG document Q&A - Regulation (EU) 2024/1860 Article 10a MDR and IVDR.

If the manufacturer has ascertained that the interruption or discontinuation of supply of the device could result in serious harm or a risk of serious harm to patients or to public health, they must directly inform the relevant stakeholders i.e.:

  1. Economic operators
  2. Health institutions
  3. Healthcare professionals
  4. The competent authority in the Member State where the manufacturer or their authorised representative is established

Where the manufacturer does not supply health institutions or healthcare professionals directly, they must inform the relevant economic operators in the supply chain, which must then inform the health institutions.

Distributors and importers

The responsibility for sharing information downstream in the supply chain lies with the economic operators, once they have received the information from the manufacturer or from another economic operator.

  • Importers: Once they have received the information from the manufacturer, importers of the device in question must, without undue delay, forward the information, as provided by the manufacturer, to all distributors to whom they supply the device directly.

  • Distributors: When they receive the information from importers, distributors must, without undue delay, forward it, as provided by the manufacturer, to all other distributors to whom they supply the device in question, as well as to the health institutions that they supply.

To preserve the integrity of the original communication, the information must always be forwarded as provided by the manufacturer until it reaches the health institutions or healthcare professionals.

REMINDER: in accordance with Article 25 of the MDR/IVDR, economic operators must have a system in place to ensure an appropriate level of device traceability. They must be able to identify their upstream suppliers and their downstream customers.

Notification of device-supply interruption or discontinuation in Luxembourg in accordance with Art.10a

All device manufacturers established in Luxembourg, or their authorised representatives established in Luxembourg, must notify the Health Directorate using the:

This form should be sent as quickly as possible to: meddevices@ms.etat.lu.

All of the required fields in the form must be completed. To enable a better assessment of the situation, additional information may be added. If the form is updated, the updated sections must be clearly flagged.

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