Poland - Medical devices

Description

The subject matter of the contract is:Rental of a surgical robot with peripheral devices along with the purchase of a set of instruments for performing procedures The Ordering Party does not allow partial bids.A detailed description of the subject matter of the contract is contained in Appendix 2b to the SWZ.
3.3 The Ordering Party's requirements for the subject matter of the contract: 1) the offered medical device must have approvals, certificates and be registered in accordance with the law requiring approvals, certificates and registration,2) the offered medical device must be marketed and used in accordance with the requirements of the Act of April 7, 2022 on medical devices ( i.e. Journal of Laws of 2022, item 974 as amended),3) the offered medical device must comply with the standards or technical specifications applicable to the device;In the event that 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 in its own scope, all actions necessary to fulfill all legal requirements related to the introduction of the device for marketing and use in the Republic of Poland. The Contractor shall be obliged to perform such activities within the time limits resulting from the applicable regulations and to provide the Ordering Party within these time limits with the relevant documents confirming the performance of such activities.3.4. In cases where the description of the subject matter of the contract indicates trademarks, patents or origin, source or a particular process that characterizes certain products or services provided by a particular contractor, it means that the Ordering Party cannot describe the subject matter of the contract in a sufficiently precise and understandable manner, however, in each such situation the Ordering Party shall allow solutions equivalent to those described above. In such situations, any reference to trademarks, patents, origin, source or a particular process that characterizes specific products or services provided by a particular contractor shall be read together with the words "or equivalent".When describing the subject matter of the contract by reference to standards, technical evaluations, technical specifications and technical reference systems referred to in Article 101(1)(2) and para. 3, the Contracting Authority allows solutions equivalent to those described In such situations, any indications should be read together with the words "or equivalent".The Contracting Authority does not provide for the award of contracts referred to in Article 214 (1) (7) of the PPL Act.The Contracting Authority does not anticipate awarding a contract referred to in Article 214 (1) (8) of the PPL Act.DESCRIPTION OF CRITERIA WHICH THE CONTRACTING AUTHORITY WILL TAKE INTO ACCOUNT WHEN SELECTING A TENDER'S OFFER, INCLUDING THE WEIGHT OF THESE CRITERIA AND THE METHOD OF EVALUATION OF TENDERS13.1. The evaluation of tenders will be carried out on the basis of the criteria specified in the TERMS of Reference and their weights. Bids will be evaluated by points. During the evaluation of the bids, the bids considered and evaluated consecutively will be awarded points for the following criteria according to the following rules:PRICE CRITERION weight: 60%TERMIN OF PERFORMANCE OF THE PARTICULAR ORDER weight: 20% i.e. the delivery date of the robot from the date of sending the call.DATE OF PERFORMANCE OF THE PARTICULAR ORDER weight: 20% i.e. the delivery date of consumables.

Opportunity closing date

17 August 2023

Value of contract

to be confirmed