Capsule endoscopy equipment

The bidder must confirm that neither it nor its management, administrative or supervisory body members, procurists or authorised representatives have been finally convicted within the last five years of participation in a criminal organisation, corruption, fraud, terrorism-related offences, money laundering, terrorist financing or offences involving child labour. The exclusion grounds also cover tax or social security payment arrears, bankruptcy or insolvency proceedings, liquidation, suspended business activities, serious professional misconduct, anti-competitive agreements, conflicts of interest, involvement in preparing the procurement procedure, material breaches of previous procurement contracts, and the submission of false information or failure to provide required documents. The bidder must also confirm that entering into the contract would not breach international or Estonian sanctions and that no applicable national exclusion ground concerns the bidder or its legal representatives. The bidder must be prepared to provide evidence or information enabling the contracting authority to verify payment of taxes and social security contributions. Where an exclusion ground exists, evidence of remedial measures restoring reliability may be submitted in cases permitted by the applicable rules.

The machine-readable notice did not include precise requirements for financial capacity, turnover, previous experience or team qualifications; these must be checked in the tender documents. To demonstrate compliance, the bidder must submit Annex 1, the technical description and compliance form, together with technical documentation for the proposed equipment. The completed pricing form (Annex 3) and equipment spare-parts list (Annex 5) must also be submitted. The offer must include the manufacturer's original English operating manuals, maintenance and repair manuals, and comprehensive Estonian operating and safety instructions. The manufacturer must confirm that technical support, including spare parts, will be available for at least 5 years. The bidder must confirm that the system bears the CE marking and complies with the requirements of Medical Devices Regulation No. 2017/747, that setup will be performed by a manufacturer-trained and authorised specialist, and that training will be delivered by a suitably trained specialist. The names, email addresses and telephone numbers of those specialists must be provided. The offer must include details of the contract signatory and contract contact person, as well as the email or web address used for ordering capsules; a power of attorney is required where the contract is signed by an authorised representative. A power of attorney for joint bidders must be submitted where applicable. The bidder must identify and justify any business secrets and confirm compliance with the tender documents; where an equivalent solution is offered, the bidder must provide an explanation and supporting evidence. Subcontractors or suppliers who are Russian citizens, residents or entities established in Russia, or entities owned or controlled by such persons, may not account for more than 10% of the contract value.