Mallinckrodt said that its Therakos Cellex Photopheresis System has achieved CE Certification under the new European Union Medical Device Regulation (EU MDR) 2017/745.
The Therakos Cellex Photopheresis System is said to be the first fully integrated and validated Extracorporeal Photopheresis (ECP) system.
Leveraging patented technology, Therakos performs ECP by collecting, separating, and treating a small quantity of white blood cells from the patient while they are connected to the device.
Therakos is employed to treat various immune-mediated diseases and is used in over 300 treatment centres across more than 30 countries worldwide.
The EU MDR 2017/745 is a regulatory certification programme for medical devices, aimed at fostering innovation while ensuring safety.
To obtain the new CE certificate, Therakos underwent a comprehensive process that included a quality management system audit of the Dublin facility, a technical review, a microbiological assessment, and an in-depth clinical evaluation.
Mallinckrodt, a global speciality pharmaceutical company, submitted the EU MDR application in September 2022.
The submission also included design enhancements like the addition of the anticoagulant ACD-A to the labelling and corresponding software updates to enhance the patient and operator experience.
The American-Irish domiciled pharmaceuticals manufacturer also seeks approval for material changes to eliminate DEHP (phthalate) and comply with the latest Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) standards.
Therakos Cellex Photopheresis System is now approved for use in patients requiring photopheresis treatment, including those over 18 with cutaneous T cell lymphoma or solid organ transplant rejection.
It is also approved for patients over three with acute and chronic graft versus host disease.
Mallinckrodt hospital international vice president Christopher Hirt said: “We are pleased Therakos has received the CE Certificate under the new EU MDR requirements that have been put in place to ensure the highest quality and safety standards for medical devices in the EU.
“Importantly, Therakos was granted this certificate after meeting the increased safety and performance requirements, which may give healthcare providers even greater confidence when treating patients.”
The latest certification comes after Mallinckrodt agreed to divest its Therakos business to CVC Capital Partners Fund IX for a purchase price of $925m.
