Tender detail

Trauma and orthopaedic metal osteosynthesis devices

Summary

The tender concerns trauma and orthopaedic metal osteosynthesis devices, specifically external fixator sets and accessories. The bidder must submit the required forms, technical data sheet and proof of product compliance. The bidder must also take into account the delivery capacity requirement, CE marking, compliance with MDR or Directive 93/42/EEC, the scientific article requirement, the power of attorney in case of a joint bid, and the sanctions and equivalence confirmations.

Reference number
311502-0000
Buyer
sihtasutus Põhja-Eesti Regionaalhaigla
Country
Estonia (EST)
Procedure
Open procedure
CPV
33183100 Orthopaedic implants
Deadline
2026-08-24
Status
Open
Contract subject
Supplies
Estimated value
3 000 000,00 EUR
Source
RHR

Participation requirements

Tender requirements are available in the official tender documents.

Compliance requirements

The tender documents include the standard exclusion grounds for criminal convictions, corruption, fraud and other mandatory grounds. The bidder must answer the required self-declaration questions and, where applicable, may provide evidence of self-cleaning. The machine-readable notice did not provide a complete list of all exclusion grounds in the excerpt, so the exact grounds must be checked in the official tender documents.

Qualification criteria and exclusion grounds

The bidder must submit the offer on the prescribed forms and attach the manufacturer’s technical data sheet in Estonian or English proving compliance with the requirements. The offered products must bear the CE marking and comply with either Directive 93/42/EEC or Regulation (EU) 2017/745 (MDR); the relevant certificates or other proof must be provided. The bidder must confirm that it can deliver the ordered goods within the expected value of the framework agreement by the end of 2026 at the latest. At least one peer-reviewed article in an international scientific journal must have been published about the offered trauma and orthopaedic metal osteosynthesis products, and the bid must include the article or a reference to it. In the case of a joint bid, a power of attorney for the joint bidders must be attached. If the bidder relies on equivalence, it must explain this where necessary and add supporting evidence. The bidder must also submit the application for participation in the procurement procedure, the completed price form, the completed technical proposal form and, where necessary, other files proving compliance with the requirements.