Tender detail

Reagents and accessories for autoimmune tests performed by the IIF method

Summary

The tender concerns reagents and accessories for autoimmune tests performed by the IIF method. The bidder must submit a bid together with the required confirmations, technical description, pricing form and manufacturer-issued evidence. The bidder must also confirm that the offered goods comply with IVDR requirements or transitional provisions and that the goods are not subject to international sanctions.

Reference number
307477-0000
Buyer
sihtasutus Põhja-Eesti Regionaalhaigla
Country
Estonia (EST)
Procedure
Open procedure
CPV
33696500 Laboratory reagents
Deadline
2026-06-01
Status
Open
Contract subject
Supplies
Estimated value
600 000 EUR
Source
RHR

Participation requirements

Tender requirements are available in the official tender documents.

Compliance requirements

The bidder must confirm the mandatory exclusion grounds in the tender documents, including criminal organisation, corruption and other criminal conviction grounds. The notice also refers to self-cleaning: if an exclusion ground exists, the bidder may provide evidence of measures taken to restore reliability, where allowed by law or the tender documents. The machine-readable notice did not include the full list of exclusion grounds, so they must be checked in the tender documents.

Qualification criteria and exclusion grounds

The machine-readable notice did not include precise selection or suitability criteria, so they must be checked in the tender documents. As compliance requirements, the bidder must submit a completed application for participation in the procurement, a completed pricing form and a completed technical description form. The bidder must be the official representative or authorised reseller of the offered product and must provide a manufacturer-issued document proving sales rights or technical support. The bidder must also confirm that the products will be transported and stored according to the manufacturer’s conditions, that the bid complies with the tender documents and that, where necessary, equivalence has been explained and supporting evidence has been attached. The products must bear the CE marking and comply with Regulation (EU) 2017/746 or be on the market under its transitional provisions; if products still comply with Directive 98/79/EC, the manufacturer’s confirmation of replacement by the end of the transition period must be included. Manufacturer technical data, certificates, safety data sheets, user instructions and storage and preservation conditions must also be provided.