provision of surgical robotic system

Economic operators submitting tenders must prove a form of registration under the law of the resident country, showing that the economic operator is legally constituted, that he is not in any of the situations of annulment of the constitution, and that he has the professional capacity to carry out the activities covered by the public contract. The requirement shall also apply to subcontractors for the part of the contract they are to undertake, which will complement the information related to their situation at the level of a separate DUAE. Method of implementation: The DUAE will be supplemented by economic operators participating in the procurement procedure with the information requested by the contracting authority - information on the fulfilment of the requirements for the ability to pursue the professional activity. The supporting document proving the fulfilment of those assumed by the completion of the DUAE, namely the finding certificate issued by the ONRC, or in the case of foreign legal / natural persons tenderers, equivalent documents proving a form of registration / attestation or professional affiliation under the conditions of the law of the country of residence, showing that the economic operator is adequately constituted, that he is not in any situation of cancellation of the constitution, and that he has the legal professional capacity to carry out all the activities covered by this contract in connection with the above mentioned requirements and the rules applicable in the country of origin / country in which the economic operator is established, translated into Romanian, at the request of the contracting authority, only by the highest bidder in accordance with the criteria set out in the contract. Where parts of the contract will be executed by subcontractors, proof of registration and correspondence of the main / secondary activities within the contract with the object of the acquisition will also be required by subcontractors for the part of the contract they will perform. The certificate or equivalent documents submitted shall contain actual / actual data at the time of presentation.

Economic operators submitting the offer must be authorized by ANMDMR for the marketing, installation, commissioning, maintenance and repair of the medical device in the procedure. How to demonstrate compliance with the requirement: will be completed DUAE by economic operators (leader, associate, subcontractor - if applicable) with the registration number of the operating opinion issued by ANMDMR. The supporting document proposing the fulfilment of those assumed by the completion of the DUAE, i.e. the Operating Opinion issued by ANMDMR in accordance with Law 95 / 2006 republished, with subsequent amendments and additions and WHO 1008 / 2016 for the types of activities provided in the field of medical devices (according to Article 926 (1) of Law 95 / 2006 - as applicable), in which the manufacturer of the medical device which is the subject of the procurement, is to be submitted, at the request of the contracting authority, only by the highest bidder in the ranking drawn up after the award criterion is applied. The opinion submitted must reflect the capacity of the tenderer on the date of submission of tenders and be valid on the date of submission of tenders. In accordance with the provisions of art. 927, paragraph (2) of Law 95 / 2006 republished, the notice of operation issued by ANMDMR should not be submitted by natural persons and legal persons established in the EU or EEA which demonstrate by supporting documents that they carry out legally marketing, installation, putting into service, maintenance and repair of the medical device in their home state.

Economic operators shall specify the part (s) of the contract they intend to subcontract. The supply of products cannot be the conf subcontractor. Art. 3 of Law 98 / 2016 with subsequent modifications and completions but only the services / works attached to the provision of products. How to demonstrate compliance with the requirement: The DUAE shall be completed by the economic operators participating in the procurement procedure with the information requested by the contracting authority and shall be attached with the DUAE and the subcontracting agreement

Implementation of the quality management system according to ISO 9001: 2015 or equivalent for the marketing / delivery / supply activity and, where appropriate, installation and maintenance of the category of product subject to the award procedure. How to demonstrate compliance with the requirement: the DUAE will be completed by economic operators (leader, associate, third supporter, subcontractor - if applicable) participants in the award procedure with the registration number of ISO 9001: 2015 or equivalent. The supporting document proving the fulfilment of those assumed by the completion of the DUAE is the Certificate issued by an accredited certification body attesting compliance with ISO 9001: 2015 or equivalent. Prior to the award of the supply contract, the contracting authority shall require the highest ranking tenderer (leader, associate, third supporter, subcontractor - if applicable), after applying the award criterion, to submit the supporting documents within the period of validity, in certified copy for compliance with the original, demonstrating compliance with the qualification criteria, in accordance with the information contained in the DUAE.