Compliance requirements
A bidder may be excluded if it, or a person in its management, supervisory or control bodies or authorised to represent or control it, has a relevant final conviction within the past five years, or remains subject to an exclusion period, for participation in a criminal organisation, corruption, fraud, terrorism-related offences, money laundering or terrorist financing, child labour or human trafficking. The grounds also cover tax offences and, as a mandatory national ground, enabling the unlawful employment of a foreign national or breaches of the conditions for their employment in Estonia, including paying less than the legally required wage.
Exclusion may also apply for unpaid taxes or social security contributions; bankruptcy, insolvency, liquidation, an equivalent procedure, administration of assets by a liquidator or court, suspension of business, or an arrangement with creditors; serious professional misconduct; agreements with other businesses to distort competition; an unresolved conflict of interest; involvement by the bidder or a related business in preparing the procurement where the resulting competitive advantage cannot otherwise be remedied; and serious or persistent breaches of previous contracts resulting in early termination, damages, price reductions or penalties.
A bidder may also be excluded for breaching environmental, social or labour obligations; submitting false information, withholding required information or failing to provide requested supporting documents; improperly influencing the contracting authority or seeking confidential information to gain an unfair advantage; or being subject to an international sanction that would make the contract unlawful. Where permitted, the bidder may submit evidence of remedial measures taken to restore its reliability.
Qualification criteria and exclusion grounds
The bidder must be registered in a business or equivalent register under the law of its country of establishment. If registration is not legally required, it must provide a copy of its founding document or equivalent.
The bidder must have completed at least one sales contract with a healthcare institution for diagnostic ultrasound systems during the 36 months preceding the procurement, with the total value of such contracts during the relevant 36-month period of at least EUR 400,000. It must provide contract details, including value, device manufacturer and model, contract date, and the other party’s contact details; for contracts awarded through the public procurement register, include the procurement reference number.
The bidder must be an authorised reseller of the proposed products and have the manufacturer’s authorisation to provide technical support for the offered system in Estonia. Evidence issued by the manufacturer must be provided.
The offer must include the completed technical specification with actual values for all parameters and references to supporting manufacturer information, manufacturer’s product information, a user manual, and a description of the proposed configuration and separately purchasable hardware and software functions. Technical descriptions and prices for optional functions, including ultrasound probes, must also be provided; the hospital may order these during the three years following signature of the framework agreement. The device must meet the technical requirements, be authorised for use in EU countries, be a medical device assessed under Directive 93/42/EEC or Regulation (EU) 2017/745, and bear the required CE marking. Evidence of the device’s risk class and electrical safety class must be supplied.
The manufacturer’s and supplier’s warranty for the device must be at least 12 months; the warranty for spare parts must be at least 6 months. The bidder must provide the warranty terms, the manufacturer’s technical maintenance requirements and recommendations, and price lists for maintenance, repairs and repair call-outs, including transport costs. Repair and call-out prices must remain valid for the framework agreement’s term; prices for additional functions must remain valid for three years from signature.
At the time of bidding, the bidder must have at least one service engineer in Estonia who speaks and writes Estonian, has at least three years’ experience and qualifications in ultrasound-system maintenance, and has manufacturer-provided training for maintenance and repair of the offered system. The bidder must provide the required confirmation and copies of training certificates. It must also provide calibration certificates for the measuring equipment, including the electrical safety tester, and tools used for maintenance, including warranty-period maintenance.
The bidder must undertake to deliver, at its own expense, an optimised and pre-configured sample in the exact proposed configuration to Pärnu Hospital within one month after the tender deadline. The sample must be available for evaluation for at least two weeks and is to be returned within seven days after the evaluation period ends. The offer must remain valid for at least six months after the submission deadline and include prices in the required format, covering delivery and installation, configuration and training at the hospital.
For a joint bid, the participants must appoint an authorised representative and provide a power of attorney. The bidder must confirm compliance with the tender documents and explain and evidence any claimed equivalence. It must also confirm that it will not involve, for more than 10% of the contract value, subcontractors or suppliers covered by the stated EU restrictions concerning Russian persons and entities, and that the offered goods are not subject to international sanctions or from sanctioned regions. The supplied document text does not specify the award-scoring formula; check the official tender documents for the evaluation details.