Norway – Medical equipments, pharmaceuticals and personal care products – 77413 RA KRE Department for Cancer Treatment Cell Prosthesing Equipment

Justification for Direct Award – Equipment for Gradient Separation of Pancreatic Tissue This procurement concerns the acquisition of new equipment for gradient separation of islet cells from pancreatic tissue at the Section for Cell Therapy (SfC), Oslo University Hospital (OUS). The contracting authority intends to procure two (2) units of Cellsaver Xtra from LivaNova AS. The estimated annual usage is 15 procedures. Please refer to the attached detailed justification. In light of the technical requirements, the need for methodological validation, and regulatory considerations, LivaNova AS is assessed to be the only supplier capable of fulfilling the requirements. The conditions for applying the negotiated procedure without prior publication, pursuant to §13-4 (2) of the Norwegian Public Procurement Regulations (FOA), are therefore considered fulfilled. Any objections must be submitted through the communication module in Mercell within 10 days of the publication of this notice.