Poland - Medical devices

Description

3.3 The Orderer's requirements concerning the subject of the order: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,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 2020, item 186If 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 fulfill all legal requirements related to marketing and use of the device on the territory of the Republic of Poland. The Contractor shall be obliged to perform such actions within the deadlines resulting from the applicable regulations and provide the Contracting Authority with appropriate documents confirming such actions.3.4. If 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 Contracting Authority cannot 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 Contracting Authority shall accept 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". The Economic Operator who invokes equivalent solutions to those described by the Awarding Entity is obliged to prove that the materials and equipment offered by him 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".3.5. The Contracting Authority reserves the right to invite the tenderer to submit samples of selected tools in order to verify compliance with the required technical parameters. The samples must be packaged in the original manufacturer's packaging individually with the catalogue number.3.6 The Awarding Entity requires that the subject matter of the contract be performed according to the terms and conditions specified in the contract, the specimen of which is attached to the SIC. DESCRIPTION OF CRITERIA WHICH THE CONTRACTOR WILL BE DIRECTED BY THE SELECTED OFFERS, WITHIN THIS CRITERIA'S WEIGHT AND THE WORK OF ASSESSMENT OF THE OFFERS.13.1 The evaluation of tenders will be conducted on the basis of the criteria specified in the SIC and their weights.Proposals will be scored separately for each Task. During the evaluation of the proposals, the following criteria will be scored according to the following rules: PRICE CRITERIA Weight: 60 % PRICE CRITERIA Weight: 20 % PRICE CRITERIA WARRANTY DURATION Weight: 20 % WARRANTY DURATION Weight: 20 %

Opportunity closing date

10 August 2020

Value of contract

to be confirmed