Medical equipments, pharmaceuticals and personal care products (Норвегия - Тендер #42849945)

Reagents for detecting bowel pathogenic microbes

Bergen Hospital Trust (HBE) intends to enter into amendment contracts with HD Medical AS (HD) and Roche Diagnostics Norge AS (Roche) for reagents for examining bowel pathogenic microbes. Førde Hospital Trust (HFD) intends to enter into amendment contracts with HD and Montebello Diagnostics AS (Montebello). The amendment concerns an extension to the contracts until 31.03.2025. HD currently has a contract with HBE and HFD for the delivery of analyses for detecting bowel pathogenic viruses and parasites. HBE has an equivalent contract for detecting bowel pathogenic bacteria with Roche, and HFD with Montebello.

Bergen Hospital Trust (HBE) intends to enter into amendment contracts with HD Medical AS (HD) and Roche Diagnostics Norge AS (Roche) for reagents for examining bowel pathogenic microbes. Førde Hospital Trust (HFD) intends to enter into amendment contracts with HD and Montebello Diagnostics AS (Montebello). The amendment concerns an extension to the contracts until 31.03.2025. HD currently has a contract with HBE and HFD for the delivery of analyses for detecting bowel pathogenic viruses and parasites. HBE has an equivalent contract for detecting bowel pathogenic bacteria with Roche, and HFD with Montebello.

The health trusts will make a new procurement that will require IVDR-certified reagents. The reason why it is desirable to postpone the start-up of the new procurement is that resources will be need for new instrumentation if IVDR-certified panels are introduced now, in a period with major financial uncertainty. Resources will be made available at the earliest in 2024/2025. This means that there is a need to continue with the current contracts. According to the schedule, the trusts will announce a new procurement of PCR analyses for bowel pathogenic microbes in 2024, and have the analyses fully implemented and ready for use in Q1 2025. Please note that this a tentative schedule.

The market is also still somewhat immature as regards IVDR-certified panels, but we are aware that there are several fully automatic systems in the market. We would like as many suppliers as possible to have the opportunity to take part in the contest when it is published.

Furthermore, it is not appropriate to procure new temporary contracts for panels that are not IVDR-certified. There are several suppliers that can deliver these, but there will be disproportional investments in time and money in relation to the procurement value to hold a contest when it is only for a short period. The procurement would be resource demanding, particularly as regards the necessary evaluation. It is therefore not appropriate to hold a contest for a temporary contract for reagents that will regardless be replaced with IVDR-certified variants after a short time.

Based on the named justifications, the contracting authority believes that there is a legal basis to enter into a contract with Roche, HD, and Montebello without announcing a contest, cf. the Public Procurement Regulations, Section 13-4 first paragraph letter c.

The contract will be signed at the earliest ten days after the date of this notice.

Bergen Hospital Trust (HBE) intends to enter into amendment contracts with HD Medical AS (HD) and Roche Diagnostics Norge AS (Roche) for reagents for examining bowel pathogenic microbes. Førde Hospital Trust (HFD) intends to enter into amendment contracts with HD and Montebello Diagnostics AS (Montebello). The amendment concerns an extension to the contracts until 31.03.2025. HD currently has a contract with HBE and HFD for the delivery of analyses for detecting bowel pathogenic viruses and parasites. HBE has an equivalent contract for detecting bowel pathogenic bacteria with Roche, and HFD with Montebello.

The health trusts will make a new procurement that will require IVDR-certified reagents. The reason why it is desirable to postpone the start-up of the new procurement is that resources will be need for new instrumentation if IVDR-certified panels are introduced now, in a period with major financial uncertainty. Resources will be made available at the earliest in 2024/2025. This means that there is a need to continue with the current contracts. According to the schedule, the trusts will announce a new procurement of PCR analyses for bowel pathogenic microbes in 2024, and have the analyses fully implemented and ready for use in Q1 2025. Please note that this a tentative schedule.

The market is also still somewhat immature as regards IVDR-certified panels, but we are aware that there are several fully automatic systems in the market. We would like as many suppliers as possible to have the opportunity to take part in the contest when it is published.

Furthermore, it is not appropriate to procure new temporary contracts for panels that are not IVDR-certified. There are several suppliers that can deliver these, but there will be disproportional investments in time and money in relation to the procurement value to hold a contest when it is only for a short period. The procurement would be resource demanding, particularly as regards the necessary evaluation. It is therefore not appropriate to hold a contest for a temporary contract for reagents that will regardless be replaced with IVDR-certified variants after a short time.

Based on the named justifications, the contracting authority believes that there is a legal basis to enter into a contract with Roche, HD, and Montebello without announcing a contest, cf. the Public Procurement Regulations, Section 13-4 first paragraph letter c.