Interruption and discontinuation of medical devices

As we had the opportunity to highlight a few months ago, on July 9, 2024, Regulation (EU) 2024/1860 was published, with the aim of introducing changes to the regulation concerning medical devices and in vitro diagnostic medical devices ("Medical Devices Regulations"), in what concerns potential situations of shortages of medical devices and of in vitro diagnostic medical devices. For more details on the changes promoted by this Regulation, we suggest reading our publication on this topic, available here.

This Regulation, among other changes, established new obligations for manufacturers regarding situations of interruption or discontinuation of the supply of certain devices, which came into force on January 10, 2025.

In general terms, we remind that, by virtue of these new rules, manufacturers (or their EU authorized representatives) are required to notify the competent authorities of situations of interruption or discontinuation of a medical device or in vitro diagnostic device, whenever the interruption or discontinuation may result in serious harm or a risk of serious harm to patients and public health. In other words, this notification must be fulfilled by manufacturers (or their EU authorized representatives) regardless of the reason for the interruption or discontinuation, whenever it may result in harm or risks to patients and public health.

From a national perspective, it is important to highlight that, in Portugal, situations of interruption or discontinuation of marketing that meet the previously identified requirements must be notified to INFARMED, I.P., as the competent authority for the regulation and supervision of the medical devices and in vitro diagnostic devices market.

For this purpose, INFARMED has clarified the procedures that must be observed by manufacturers and/or representatives based in national territory, through the publication of Informative Note No. 114/CD/100.20.200.

In summary, and contrary to what happens with medicinal products where notifications are made through specific platforms managed by INFARMED, the communication of situations of interruption or discontinuation of medical devices should be carried out by sending, via email (to uss@infarmed.pt), the form model prepared by the MDCG for this purpose – available here.

Still in the context of this matter, we take the opportunity to remind that, on July 4, 2024, Decree-Law No. 29/2024 came into force, which ensured the implementation of the Medical Devices Regulations in the Portuguese legal system and established the respective sanctioning framework.

Thus, and interestingly, the implementation of national procedures for reporting situations of interruption and discontinuation appears as another measure in the context of the adaptation of the Portuguese legal and regulatory framework to the European Medical Devices Regulations, at a time when the medical devices industry has been called to share their experience with these Regulations, with a view to their revision in the near future.