Q&A Published by the EU Commission Regarding Information Obligation In Case of Interruption or Discontinuation of Supply of Certain Medical Devices or In-Vitro Diagnostic Devices

The EU Commission has released a Q&A document regarding the Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices or In-Vitro Diagnostic Devices, a measure first introduced in the amendment (EU) 2024/1860. To offer some background to this document, earlier this year, an amendment to the IVDR and MDR, dubbed as (EU) 2024/1860 was published in the OJEU. Regulation (EU) 2024/1860 addresses three key areas:

1. Ensuring Patient Safety and Uninterrupted Device Supply: Regulation (EU) 2024/1860 prioritizes patient safety and public health by aiming to prevent the risks associated with the discontinuation or interruption of in vitro diagnostic medical devices (IVDs) critical for healthcare services. This amendment extends timelines for manufacturers and notified bodies to conduct conformity assessments of IVDs under the IVDR. These assessments apply to IVDs already certified or declared conformant under Directive 98/79/EC. A separate document provides detailed questions and answers on the extension of IVDR transitional periods.
2. Manufacturer Obligations on Supply Interruptions: The regulation introduces a requirement for manufacturers to inform relevant competent authorities and health institutions before interrupting or discontinuing the supply of specific medical devices or IVDs. If manufacturers do not supply directly to healthcare institutions or professionals, they must notify the appropriate economic operators in the supply chain, who will then inform health institutions. This mechanism allows authorities and institutions to implement mitigating measures, helping safeguard patient health. The Q&A document is concerning this area.
3. Phased Implementation of Eudamed: Regulation (EU) 2024/1860 facilitates the gradual activation of finalized electronic systems within the European Database on Medical Devices (Eudamed) instead of waiting for all six modules to be completed. This phased roll-out will improve transparency and provide accessible information on device registrations, economic operators, and certificates across the EU, supporting better monitoring of device availability. A separate document will cover questions and answers on this aspect.

The Q&A can be accessed using the following link