Compliance requirements
The tender notice includes the standard exclusion grounds for criminal organisation, corruption and fraud. The bidder or its management, administrative or supervisory body members, or persons authorised to represent, decide for or control the bidder must not have a final conviction within the last five years for these offences, unless the exclusion period stated in the conviction has already expired. If an exclusion ground applies, the bidder may submit evidence of self-cleaning measures. The notice also indicates that the bidder should check the official tender documents for the exact wording and any additional exclusion grounds.
Qualification criteria and exclusion grounds
The bidder must submit the tender with the required forms and evidence. In a joint tender, a power of attorney from the joint bidders must be attached. The bidder must confirm that the tender complies with the procurement documents, that the tender has been submitted on the required form, and that the price offer follows the prescribed structure. If the signatory does not have statutory representation rights, a power of attorney proving the signatory’s authority must be submitted. A document from the manufacturer or authorised supplier proving sales rights or technical support for the offered product must be provided. For the warranty period and the subsequent period, the bidder must have at least one medical technology specialist who has received manufacturer training for servicing and repairing the device; the specialist’s details and the manufacturer’s training confirmation must be submitted. The offered device must be authorised in EU countries, bear the CE mark and comply with Medical Devices Regulation MDR 2017/745; a declaration of conformity or a copy must be provided. For the assessment of compliance, technical descriptions, manufacturer information materials, certificates, declarations of conformity and other evidence must be attached, as well as an excerpt from the device maintenance manual. The machine-readable notice did not include precise qualification or compliance requirements; these must be checked in the tender documents.