TÜV SÜD, reinstated Getinge’s CE certificate for HLS and PLS consumables, used for ECLS therapy, with certain conditions. The reinstatement of the CE certificate is a result of committed work and a close and constructive dialogue between Getinge and TÜV SÜD.
 
In March 2023, Getinge’s CE certificate for the consumables HLS and PLS sets used for extracorporeal life support (ECLS) was suspended due to a potential defect in the sterile packaging. However, under the exemption provided by EU MDR Article 59, sales have still been able to continue to countries that require CE certification.
 
A new packaging solution has been developed by Getinge, and an application for CE approval was submitted to the notified body TÜV SÜD in Q2 2024. TÜV SÜD has now evaluated the application and decided to reinstate the CE certificate, with certain conditions to be fulfilled. Getinge expects to regain deliveries of the HLS and PLS consumables in Q4 2024.
 
Temporary challenges with a supplier and production changeover related to the new packaging solution have resulted in a lower volume of HLS and PLS sets available for shipment in Q3 2024. 
 
“We are aware of the very problematic situation this product shortage puts healthcare professionals and critically ill patients in. Therefore, we are working urgently and in close dialogue with our customers to minimize the impact,” said Elin Frostehav, President Acute Care Therapies at Getinge.
 
TÜV SÜD has also announced that the temporary suspension of Getinge’s Cardiosave Intra-Aortic Balloon Pump, effective from March 2024, will be extended until July 1, 2025. 
 
This decision does not affect the already installed base of Cardiosave. This means that products already on the market can continue to be used. Consumables, service, and spare parts for the pumps are not affected. The decision is not deemed to be financially material for Getinge.