Single-use operating sets

The exclusion grounds include at least participation in a criminal organisation, corruption and other criminal-conviction-related grounds listed in the ESPD. The bidder or members of its management body must not have been finally convicted of those offences within the last five years, or the disqualification period stated in the conviction must have expired. If an exclusion ground applies, the bidder may submit evidence of self-cleaning measures where permitted. The machine-readable notice did not set out all exclusion grounds in full; they must be checked in the tender documents.

The bid must comply with the tender documents and the technical specification. The bidder must submit the RHAD Annex I technical description/bid form, the manufacturer’s technical documentation, one sterile sample set for all offered products, and confirm that all products bear the CE mark and comply with MDR 2017/745. The offered products must have a local product representative in Estonia who speaks Estonian. The bidder must also confirm equivalence where it relies on an equivalent solution and provide the required contact person details. Conditional bids are not allowed. The machine-readable notice did not set out all qualification, suitability or compliance requirements in full; they must be checked in the tender documents.