Norvegia - Apparecchiature mediche, prodotti farmaceutici e prodotti per la cura personale - Consultazione sul progetto di documenti di gara - 78100-1 Isolatore per il laboratorio di controllo qualità

Consultation on draft tender documents - isolator for QC laboratory, ATMP Norway From: Oslo University Hospital HF, Department of Medical Technology Case number: 78100-1 Date: 02.10.2026 Response deadline: 23.10.2026 This is a consultation - not a competition No tenders shall be submitted in this consultation. Information provided in the consultation is not binding on any of the parties. The competition will be announced in the tender management system (KGV), and tenders may only be submitted in the announced competition. Background Oslo University Hospital HF (the Customer) is preparing the procurement of an isolator for inoculation of ATMP products for sterility testing. The equipment will be installed in a new QC laboratory at the Norwegian Radium Hospital and operated under the manufacturing authorisation of the Department of Cellular Therapy. The laboratory is part of the nationally funded service ATMP Norway. Enclosed is a complete draft of the tender documents for consultation. The consultation is a preliminary market consultation under Section 12-1 of the Norwegian Public Procurement Regulations (FOA). The competition is planned to be announced in November 2026. What we ask you to respond to in the consultation Environmental requirements (Requirements Specification items 2.43-2.47, 4.6, 7.1-7.2 and 8.1-8.2) We ask for responses to all environmental requirements in the Requirements Specification. For each requirement, please state whether your solution meets the requirement, how this can be documented, and whether, in your opinion, the requirement is relevant and suitable for differentiating between solutions. Suggestions for other environmental requirements relevant to this type of equipment are welcome. Input on the tender documents We ask for input on the complete tender documents including annexes, including: whether any requirements in the Requirements Specification exclude solutions that, in your opinion, would meet our needs; whether any requirements in the Requirements Specification are unclear or difficult to respond to; whether there are matters of importance for operation, qualification or maintenance that are not covered; whether there are contract terms that the supplier would not be able to accept; whether the price form allows you to price your entire solution, including whether any cost elements are missing, unclearly described or do not fit the way you price. Please link your input to the relevant document and requirement number or section, with a brief justification. Delivery time to Ready for Operation We ask for the delivery time from Order to Ready for Operation (meaning that the equipment has been delivered, installed and configured in accordance with the contract, that the final inspection has been completed with an approved result, and that the documentation has been delivered). Where the tender documents specify deadlines or milestones, we ask for your assessment of whether these are achievable. Conditions for the consultation The consultation entails no obligation for the Customer. Participation gives no advantage in the subsequent competition, and suppliers who do not participate will not be disadvantaged. The Customer will take appropriate measures under Section 12-2 of the FOA to ensure that no supplier obtains an unfair competitive advantage. Contact and responses Input on the tender documents shall be submitted via the communication module in Mercell by 23.10.2026. Questions about the consultation shall be directed to the same channel.