Compliance requirements
The bidder must confirm that neither it nor its management, administrative or supervisory board members or authorised representatives have, during the last five years, been finally convicted of participation in a criminal organisation, corruption, fraud, terrorism, money laundering or terrorist financing, illegal use of child labour, or human trafficking-related offences. Exclusion may also apply where the bidder has tax or social security payment debts; the stated tax debt threshold is EUR 0, subject to the exceptions described in the European Single Procurement Document for debts below EUR 100 or debts being rescheduled. The bidder must not be bankrupt, in liquidation, subject to insolvency proceedings, in an arrangement with creditors, or in a situation where its assets are administered by a liquidator or court, and its business activities must not be suspended. The exclusion grounds also cover serious professional misconduct, agreements distorting competition, an unresolved conflict of interest, serious previous contract breaches, false information, failure to provide required documents, and attempts to improperly influence the procurement procedure. The bidder must confirm that the goods are not subject to international sanctions and do not originate from sanctioned regions. The bidder must also not use subcontractors or suppliers accounting for more than 10% of the contract value if they are Russian nationals, residents or entities established in Russia, entities more than 50% directly or indirectly owned by such persons or entities, or persons acting on their behalf or instructions. Where an exclusion ground applies, the bidder may need to describe remedial measures and provide supporting evidence of restored reliability.
Qualification criteria and exclusion grounds
The machine-readable notice does not specify concrete requirements concerning turnover, previous experience, personnel or other financial capacity; any such possible conditions must be verified in the tender documents. The bidder must provide the required self-declarations regarding eligibility and the absence of exclusion grounds. The tender must be submitted using the Annex 1 technical specification and tender form, and pricing information must follow the structure provided in the worksheet titled “Award criteria and rated indicators”. For each offered product, the bidder must provide a manufacturer’s catalogue, information material or technical data sheet, together with manufacturer-issued conformity documents. Products must bear the CE marking and comply with Regulation (EU) 2017/745 on medical devices. Where an equivalent product or solution is offered, the bidder must provide explanations and evidence of equivalence where necessary. In a joint tender, a power of attorney for the joint bidders must be included. At the contracting authority’s request, two original-packaged samples of each offered product must be delivered within five working days to Herne 29, Tallinn; failure to submit the samples or non-compliance identified during functional testing will render the tender non-compliant.