Consumables for a spinal surgery neuromonitoring device

The machine-readable notice includes mandatory exclusion grounds related to criminal organisation participation, corruption, fraud and other standard exclusion grounds in the ESPD. The bidder or its managers, representatives or supervisory board members must not have final convictions within the last five years for the listed offences, unless the exclusion period has expired or the tender documents allow self-cleaning and the bidder can prove it. The notice also refers to possible evidence of reliability restoration and electronic availability of evidence where applicable. The exact full list and any additional exclusion grounds must be checked in the official tender documents.

The bid must comply with the conditions set out in the procurement documents and the technical specification. The bidder must submit the RHAD Annex I technical specification / bid form and confirm that the offer has been prepared according to the required structure. The bidder must provide the manufacturer’s technical documentation and other evidence that allows the contracting authority to verify the characteristics and compliance of the offered products. All offered products must bear the CE marking and comply with Medical Device Regulation MDR 2017/745. All accessories must be suitable for use with the NIM Eclipse neuromonitoring device by Medtronic, and they must be new and manufactured no earlier than 2025. If requested, the bidder must provide product samples for testing within 5 working days after the contracting authority’s notice, one piece of each offered consumable. If an equivalent product is offered, equivalence must be explained and supporting evidence must be attached. The machine-readable notice did not include precise selection or suitability criteria; these must be checked in the official tender documents.