Compliance requirements
The tender documents include the standard exclusion grounds under the Estonian Public Procurement Act, including convictions for participation in a criminal organisation, corruption, fraud, terrorist offences and related crimes. If an exclusion ground applies, the bidder may, where allowed, provide evidence of self-cleaning and restored reliability. The machine-readable notice did not include the full list of exclusion grounds; they must be checked in the official tender documents.
Qualification criteria and exclusion grounds
The bidder’s net turnover for the last three financial years must total at least EUR 400,000 excluding VAT. The bidder must provide turnover data in the ESPD and, on request, documents proving the turnover. The bidder must prove that it has the right to sell the offered diagnostics and analysis software in Estonia. Together with the tender, the bidder must submit a document, or copy of a document, proving the representation right granted by the manufacturer or the manufacturer’s authorised representative; in case of sub-authorisation, the corresponding additional authorisations must also be submitted. The offered diagnostics must bear the CE mark and comply with Regulation (EU) 2017/746 or be on the market under its transitional provisions. Together with the tender, the bidder must submit declarations of conformity and, where applicable, certificates of conformity issued by a notified body. If the products are on the market under the transitional provisions, the bidder must also submit a declaration of conformity to Directive 98/79/EC and the manufacturer’s confirmation that compliance with Regulation (EU) 2017/746 will be ensured by the end of the transition period. The tender must comply with the procurement documents, and the bidder must submit Annex 1 technical specification, Annex 2 price form, informative materials and product leaflets. If the tender is submitted jointly, an authorised representative must be appointed and a joint bidders’ power of attorney must be submitted. The machine-readable notice did not include any more precise qualification or compliance requirements; these must be checked in the official tender documents.