Robot-assisted system for knee and hip arthroplasty

Summary

The procurement covers the delivery, installation and commissioning of a mobile robot-assisted system for hip and knee joint replacement surgery. The contractor must also provide pre-operative planning, an initial set of instruments, integration with the hospital’s IT systems, user instruction and training, and system maintenance. The application for unicondylar knee replacement is optional and may be called off by the buyer within 36 months of contract award. Implants are not included in the procurement; however, the bid must identify compatible implant systems and provide related pricing information, as well as prices for case-specific consumables. The system must be authorised under the EU Medical Device Regulation for both hip and knee procedures. Bone preparation must remain under continuous surgeon control; fully autonomous cutting systems are not permitted. HL7 and DICOM connections, automated patient-data transfer without manual duplicate entry, and data-protection and information-security documentation are required. The bid must state the total investment, maintenance and consumables costs over 8 operating years. Price is the sole award criterion, and the lowest total price is evaluated most favourably. The bidder must demonstrate average annual turnover of at least EUR 10,000,000 over the last 3 completed financial years and provide 4 suitable references from the last 3 years for delivery of an equivalent or higher model. The bid must include the required conformity, registration, reference, insurance, technical and pricing documents. It must be submitted by the deadline through the electronic procurement platform; bids and communications must be in German.