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Home / Medical Devices / MD Interruptions

MD Interruptions

Interruption or discontinuation of supply of certain medical devices and in vitro diagnostic medical devices as per Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

Article 10(a) of the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 obliges manufactures of medical devices to inform the National Competent Authority in case of anticipated interruption or discontinuation of supply of certain devices including medical devices or In Vitro Diagnostics medical devices, which could result in serious harm or a risk of serious harm to patients or public health.

Manufacturers are obliged to inform:

  • The competent authority of the Member State where they or their authorised representative is established.

  • The economic operators, health institutions, and healthcare professionals to whom they directly supplied the device.

The information must be provided by the manufacturer at least 6 months before the anticipated interruption or discontinuation, except in exceptional circumstances. The manufacturer is to specify the reasons for the interruption or discontinuation in the information provided to the competent authority.

Notifying the Malta Medicines Authority of a supply disruption

If you are a manufacturer based in Malta, or a manufacturer based outside the EU with an authorised representative located in Malta, you are required to notify the Malta Medicines Authority, other supply chain actors, and the healthcare institutions of the planned interruption or discontinuation, by completing the Manufacturer Information Form https://health.ec.europa.eu/medical-devices-sector/new-regulations_en.

Please submit the completed form via email to mdassessors.medicinesauthority@gov.mt.

Refer to the European Commission Q&A document explaining the practical requirements for complying with Article 10(a) https://health.ec.europa.eu/medical-devices-sector/new-regulations_en.

Required actions to be taken by importers and distributors upon receiving notification of an anticipated interruption or discontinuation of a device

Importers and distributors who receive a notification of an anticipated interruption or discontinuation of a device should promptly notify the entity to whom they directly supplied the device, with the original communication from the manufacturer.