Compliance requirements
The bidder may be excluded for relevant final convictions of the bidder or its management, supervisory or representative persons, including participation in a criminal organisation, corruption, fraud, terrorism-related offences, money laundering or terrorist financing, and child labour or human trafficking. The grounds include failure to pay taxes or social security contributions, subject to the applicable rules; the notice states that an Estonian tax debt below EUR 100, excluding certain undetermined interest, or a rescheduled debt does not result in issuance of a tax-debt certificate.
Other grounds include insolvency, bankruptcy, liquidation, an analogous proceeding, an arrangement with creditors, a liquidator or court managing the bidder’s assets, or suspended business activities; serious professional misconduct; agreements with other businesses intended to distort competition; an unmanageable conflict of interest; involvement in preparing the procurement where this creates an unremediable competitive advantage; and significant or repeated breach of an earlier contract resulting in early termination, damages, a price reduction or a penalty. Exclusion may also follow from false or misleading information, withholding requested information or documents, or improperly seeking confidential information or influencing the contracting authority’s decisions; breaches of environmental, social or labour obligations; enabling the unlawful employment of a foreign national, including payment below the statutory wage rate; being subject to an international sanction; or convictions for tax offences. Where permitted for this procurement, the bidder may provide evidence of measures taken to restore its reliability.
Qualification criteria and exclusion grounds
The bid must meet the tender documents and technical description; conditional bids are not permitted. Submit the bid using Annex 1, the technical description bid form, and provide prices in the structure specified in the pricing worksheet. The submitted technical information must identify the offered products and demonstrate compliance with the applicable specifications.
If requested by the contracting authority, provide product samples in their original packaging within five business days of the request, delivering them to Herne 29, Tallinn (ITKH Central Warehouse). Each sample must be in a sealed, properly marked package bearing the procurement title, reference number and bidder’s name. Failure to provide samples, or a sample’s failure to meet the requirements during functional testing or use, makes the bid non-compliant. Sample quantities for each lot are specified in Annex 1.
All offered products must bear the CE marking, comply with Regulation (EU) 2017/745 on medical devices and be free of DEHP. Submit manufacturer-issued documents confirming regulatory compliance for each product. Where an offered product is equivalent to a referenced standard, mark or other requirement, explain the equivalence and provide supporting evidence; other appropriate evidence may be accepted where the required conditions are demonstrated.
Identify any information in the bid claimed as a trade secret and explain why it qualifies; prices and other specified evaluation-related figures may not be designated as trade secrets. Joint bidders must appoint an authorised representative and include the power of attorney. Confirm that the offered goods are not subject to international sanctions and do not originate from sanctioned regions. For procurements covered by the relevant EU restrictions, confirm that more than 10% of the contract value will not be performed by subcontractors or suppliers that are Russian nationals, residents or established in Russia, are more than 50% owned by such persons or entities, or act on their behalf. The supplied documents do not specify financial, turnover or prior-experience thresholds.