Poland - Disposable non-chemical medical and haematological articles

Description

3.3 Ordering Party's requirements concerning the subject matter of the contract (if applicable): 1) the offered medical device must have certificates, attestations and be registered in accordance with legal regulations requiring certificates, attestations and registrations,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 (Dz. U. of 2019r, 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 account, all activities necessary to fulfil all legal requirements related to the product's marketing and use on the territory of the Republic of Poland. The Contractor shall be obliged to perform such actions within the time limits specified in the applicable regulations and to provide the Contracting Authority with appropriate documents confirming the performance of such actions within such time limits. In cases where the description of the subject of the contract indicates trademarks, patents, origin, source or a particular process that characterizes specific products or services, it means that the Contracting Authority cannot describe the subject of the contract with sufficiently precise terms and this is justified by the specificity of the subject of the contract, however, in any such situation the Contracting Authority allows for a solution equivalent to the one described above. In such situations, any references to trademarks, patents, origin, source or specific process should be read together with the words "or equivalent". A Economic Operator who refers to equivalent solutions described by the Contracting Authority is obliged to demonstrate that the materials and equipment offered by him meet the requirements specified by the Contracting Authority at a level not lower than that indicated in the description of the subject matter of the contract.In situations where the Contracting Authority describes the subject of the contract by reference to standards, European technical assessments, approvals, technical specifications and technical reference systems referred to in Article 30(1)(2) and (3) of the PPL Act, the Contracting Authority shall at the same time allow for solutions equivalent to those described herein. In such situations, any possible indications should be read together with the words "or equivalent".3.5 The Contracting Authority requires the performance of the subject matter of the contract on the terms specified in the contract, the specimen of which is attached to the ToR.3.The Contracting Authority reserves the right to call upon Economic Operators, in case of any doubts, to submit a sample of the offered subject of the contract in order to verify its compliance with the descriptions contained in the TITLE DESCRIPTION OF THE CRITERIES THAT THE ORDER WILL BE DIRECTED BY THE CHOICE OF THE SELECTED OFFER, AND WITHIN THE SUBJECT OF THESE CRITERTIES AND THE PERSON OF THE EVALUATION OF THE OFFER13.1. Tenders will be evaluated on the basis of the criteria specified in the ToR and their weights. Tenders will be scored separately for each Task. During the evaluation of tenders, the following criteria will be scored according to the following rules: CRITERION PRICE Weight: 60 % CRITERION OF TIME DURATIONS FOR PARTICIPATION OF THE PARTICIPATION ORDERS Weight: 40 %.

Opportunity closing date

19 September 2019

Value of contract

to be confirmed