MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices

The Medical Device Coordination Group (MDCG) has recently published document MDCG 2024-16, introducing a new Manufacturer’s Information Form. This form aims to enhance transparency and communication regarding the interruption or discontinuation of the supply of certain medical devices and in vitro diagnostic devices in the European market.

The new form is designed to ensure that any disruptions in the availability of critical medical devices are properly communicated and managed. Manufacturers will now be required to inform relevant authorities, healthcare professionals, and other stakeholders about potential supply issues, allowing for timely and coordinated responses.

This update is particularly important for ensuring patient safety. By notifying stakeholders about supply disruptions in advance, healthcare professionals and institutions can better prepare and manage risks associated with the unavailability of essential devices. It also supports regulatory compliance, as manufacturers will be better positioned to meet the new obligations set forth by the European regulations.

Moreover, the implementation of this form facilitates planning and management for healthcare providers and distributors, enabling them to adjust supply chains and ensure continuous access to critical medical devices. With these changes, the medical device sector moves toward greater transparency and efficiency in managing device availability.