Compliance requirements
A bidder may be excluded for final convictions within the preceding five years, or an exclusion period that remains in force, involving participation in a criminal organisation, corruption, fraud, terrorist offences, money laundering or terrorist financing, child labour or other forms of human trafficking. The grounds also cover failure to pay taxes or social security contributions; bankruptcy, insolvency, liquidation, suspended business activity or comparable situations; serious professional misconduct; breaches of environmental, social or labour-law obligations; agreements intended to distort competition; an unmanageable conflict of interest or an unfair advantage from involvement in preparing the procurement; and serious or repeated breaches of previous contracts, including early termination, damages or comparable sanctions. Exclusion may also apply for false or misleading information, withholding information, failure to provide requested supporting documents, or improper attempts to influence the procedure or obtain confidential information. National grounds include enabling the unlawful employment of a foreign national, being subject to an international sanction, and relevant tax-offence convictions. Where permitted, the bidder may provide evidence of measures taken to restore its reliability.
Qualification criteria and exclusion grounds
The notice and tender documents provided do not specify separate bidder qualification requirements such as turnover or prior experience; check the official tender documents for any further requirements. The stated compliance requirements apply to all three lots:
- Submit a bid for the relevant lot using the required price structure and the technical description and bid form, including information about the offered products. Conditional bids are not permitted. The bid must accept the tender-document conditions and include the required contact details for the contract signatory and the contract-performance contact person; include a power of attorney if applicable.
- All offered products must bear the CE mark and comply with Medical Device Regulation (EU) 2017/745. Include manufacturer-issued technical documentation to allow the products’ characteristics and compliance to be checked. The contracting authority may request further supporting documents.
- Explain and provide evidence for any claimed equivalence where relevant. Mark any business secrets in the bid and justify the designation; prices and other evaluation-related indicators may not be classified as business secrets.
- Confirm that the goods are not subject to international sanctions and do not originate from sanctioned regions. For procurements to which the relevant EU Russia sanctions apply, do not involve, for more than 10% of the contract value, subcontractors or suppliers that are Russian nationals, residents or entities established in Russia; entities more than 50% owned by such persons or entities; or persons or entities acting on their behalf or at their direction.