US-based medical device manufacturer Therakos has received CE certification under the EU’s revised Medical Device Regulation (EU MDR) 2017/745 for Therakos CELLEX, its Extracorporeal Photopheresis (ECP) system.
ECP is a form of immunomodulation therapy that has demonstrated efficacy in a range of T-cell and autoimmune diseases. Therakos’s CELLEX enables ECP, a process in which a small amount of white blood cells are extracted, treated, and reinfused into patients to help modify their immune response.
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Under the revised EU MDR, Therakos CELLEX is approved for use in patients older than 18 years with cutaneous T-cell lymphoma or solid organ transplant rejection (heart, lung) and patients aged three and above with acute and chronic graft versus host disease who require photopheresis.
To achieve the CE certification, the application for which Therakos submitted in September 2022, the company underwent a quality management system audit of its Dublin site, technical and microbiological reviews, and an in-depth clinical assessment.
Therakos also included two design enhancements for its system in its submission: the addition of the anticoagulant ACD-A to the current labelling and relative software changes to ensure optimal patient and operator experience, and material changes to remove DEHP (phthalate) and ensure compliance with the latest Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) standards.
The revised EU MDR became fully applicable to all medical devices on 27 May 2024.
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By GlobalDataChristopher Hirt, managing director and vice president of Hospital International at Therakos’s parent company Mallinckrodt, commented: “Therakos was granted this certificate after meeting the increased safety and performance requirements, which may give healthcare providers even greater confidence when treating patients.”
Last month, Ireland-based Mallinckrodt, which acquired Therakos from private equity company The Gores Group for $1.3bn in 2015, announced that it had reached an agreement to sell the business to investment company CVC Capital Partners for $925m.
In January 2024, contract research organisation 1MED unveiled a recertification compliance software, MED Compliance Pack, to help companies comply with the EU MDR.
