Compliance requirements
The exclusion grounds include at least participation in a criminal organisation, corruption, fraud and the other statutory exclusion grounds set out in the ESPD. The bidder, or members of its management, administrative or supervisory body, a proxy holder or other person authorised to represent it, must not have been finally convicted of those offences within the last five years, unless the law or the tender documents provide otherwise. If an exclusion ground applies, the bidder may submit evidence of self-cleaning measures where this is permitted. The machine-readable notice did not set out all exclusion grounds in full; they must be checked in the tender documents.
Qualification criteria and exclusion grounds
The tender must comply with the procurement documents and the technical specification. The bidder must submit the RHAD Annex I technical description and bid form and complete the bid price in the required structure. All offered products must be CE marked and comply with Medical Device Regulation MDR 2017/745. All offered products must be DEHP-free. Each product package must show the product name, reference code, sterilisation date and size/dimensions. Sterile packaged products must be easy to handle and must remain sterile when opened. If requested, the bidder must provide product samples within 5 working days from the buyer’s notice. The bidder must also provide the required contact details for the person signing the contract and the contact person for contract performance. The bidder must confirm that the bid complies with all tender document requirements and that, where necessary, equivalence has been explained and supporting evidence has been attached. Goods that are subject to international sanctions or originate from sanctioned regions are not allowed. The bidder must also confirm that it will not involve subcontractors or suppliers subject to the sanctions rules for more than 10% of the contract value. The machine-readable notice did not include precise qualification or suitability criteria; they must be checked in the tender documents.