Notification requirement for forecasted shortages of medical devices
Published:
Changes
From January 10, 2025, manufacturers of medical devices and in vitro diagnostic medical devices are required to notify forecasted supply shortages.
The regulations on medical devices and in vitro-diagnostic Medical Devices were amended in June 2024. One of the adopted amendments was a new provision, MDR and IVDR Article 10a, which requires manufacturers to report supply shortages on their products.
Requirements for manufacturers
The requirement applies to manufacturers, both within and outside the EU/EEA, and applies to all medical devices and in vitro diagnostic medical devices that have been placed on the European market, except for devices that are custom-made. Only forecasted shortage situations that can cause serious harm or a risk of serious harm to patients or public health need to be reported. The manufacturer is required to notify all the economic operators and health institutions in the supply chain to whom the manufacturer has sold the device, until the notification reaches the health institutions or healthcare personnel who use the equipment. This is important, so that the user of the medical device may take necessary precautions.
Norwegian manufacturers
Norwegian manufacturers must also report forecasted shortages to NoMA. The report is made by filling out the Manufacturer Information Form and sending the form to 10a@noma.no.
DMP will further inform other countries in the EU/EEA, as well as the European Commission. Manufacturers can receive assistance in reporting the forecasted shortage, but the obligation rests on the manufacturers themselves. More information and guidance on shortage reports for medical devices can be found in a separate Q&A document.