Getinge’s CE certificate for ECLS consumables reinstated
The notified body, TÜV SÜD, reinstates Getinge’s CE certificate for HLS and PLS consumables, used for ECLS therapy, with certain conditions. 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, which is expected to be phased into Q4 2024.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