Poland - Medical devices

Description

The subject of the order is:Delivery of medical equipmentPlease 1 - electromagnetic navigation for the Laryngology and Laryngology Oncology Ward.A detailed description of the subject of the order is included in Annexes 2b and 5 to the ToR.
3.3 The Orderer's requirements concerning the subject matter of the order:3.1) the offered medical device must have attestations, certificates and be registered in accordance with the legal regulations requiring the possession of attestations, certificates and registration; 3.2) the offered medical device must be marketed and used in accordance with the requirements of the Act of 20 May 2010 on Medical Devices (Journal of Laws of 2020, If the offered medical device does not require notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the Contractor shall be obliged to perform, at its own expense and on its own, all activities necessary to meet all legal requirements related to marketing and use of the product on the territory of the Republic of Poland. The Contractor shall be obliged to perform such activities within the deadlines resulting from the applicable regulations and provide the Contracting Authority with appropriate documents confirming the performance of such activities within these deadlines. The Contracting Authority shall require performance of the subject matter of the contract according to the rules specified in the contracts, specimens of which are appendices to the ToR. 3.4 The Contracting Authority allows for submission of equivalent tenders. In the cases when the description of the subject matter of the contract specifies trademarks, patents, origin, source or a specific process which characterizes specific products or services, it means that the Awarding Entity may not describe the subject matter of the contract by means of sufficiently precise descriptions and this is justified by the specificity of the subject matter of the contract, however, in each such situation the Awarding Entity shall allow for a solution equivalent to the one described above. In such situations possible indications for trademarks, patents, origin, source or a specific process should be read together with the words "or equivalent". A contractor who invokes equivalent solutions to those described by the Awarding Entity shall be obliged to prove that the materials and equipment they offer meet the requirements specified by the Awarding Entity at a level not lower than that indicated in the description of the subject matter of the contract.In situations when the Awarding Entity describes the subject matter of the contract by reference to standards, European technical evaluations, approvals, technical specifications and technical reference systems referred to in art. 30 item 1 point 2 and item 3 of the PPL Act, the Awarding Entity shall at the same time allow for solutions equivalent to those described. In such situations possible indications should be read together with the words "or equivalent".13.1. The evaluation of tenders will be carried out on the basis of the criteria specified in the ToR and their weighting. During the evaluation of the tenders, the tenders which are successively examined and evaluated are awarded points for the following criteria according to the following rules: - price criterion - weighting: 60%,- contract performance deadline criterion - weighting: 20%,- warranty period criterion - weighting: 20%.

Opportunity closing date

10 August 2020

Value of contract

to be confirmed