Poland - Disposable, non-chemical medical and haematological articles

Description

3.3 The Orderer's requirements concerning the subject matter of the order (if applicable):1) the offered medical device must have attestations, certificates and be registered in accordance with the legal provisions 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 of 2019r, item 175),3) the offered medical device must comply with standards or technical specifications applicable to the device; In case 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 device on the territory of the Republic of Poland. The Economic Operator shall be obliged to perform such actions within the time limits resulting from the applicable regulations and provide the Contracting Authority with appropriate documents confirming such actions.3.4. In the cases where 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 allow for a solution equivalent to the one described above. In such situations, possible indications for trademarks, patents, origin, source or a specific process shall be read together with the words "or equivalent". A contractor who invokes equivalent solutions described by the Ordering Party shall be obliged to prove that the materials and equipment offered by him meet the requirements specified by the Ordering Party at a level not lower than that indicated in the description of the subject of the contract.In situations where the Contracting Authority describes the subject matter of the contract by reference to standards, European technical assessments, approvals, technical specifications and technical reference systems referred to in art. 30 sec. 1 item 2 and sec. 3 of the PPL Act, the Contracting Authority also allows 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, in case of any doubts, to call upon the Contractors to submit samples of the offered assortment in the number of 3 pieces - in order to verify its compliance with the descriptions included in the ToR. Failure to submit the required samples or submitting samples that do not meet the requirements specified in the ToR will result in rejecting the offer pursuant to art. 89 sec. 1 item 2 of the Act PPL.3..6 The Awarding Entity requires that the subject matter of the contract be performed according to the rules specified in the contract, the specimen of which is attached to the ToR. DESCRIPTION OF CRITERIA WHICH THE CONTRACTOR WILL BE DIRECTED BY THE SELECTING OF OFFERS, WITHIN THIS CRITERIA'S WEIGHT AND THE WORK OF ASSESSMENT OF OFFERS.13.1 Evaluation of tenders will be conducted on the basis of the criteria specified in the ToR and their weights.Proposals will be scored separately for each Task. During the evaluation of the proposals, the proposals that are successively examined and evaluated will be awarded points for the following criteria according to the following rules: PRICE CRITERIONS Weight: 60 %Crime limit for PARTICIPAL ORDERS Weight: 40 %

Opportunity closing date

24 February 2020

Value of contract

to be confirmed