Poland - Cardiac pacemaker devices

Description

3.3 Requirements of the Contracting Authority concerning the subject matter of the contract: 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 20.5.2010 on Medical Devices (Journal of Laws of 2019, 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 activities within the time limits specified in the applicable regulations and to provide the Contracting Authority with appropriate documents confirming the performance of such activities within such time limits.The evaluation of the offers will be carried out on the basis of the criteria specified in the ToR and their weightings. During the evaluation of the offers successively considered and evaluated offers, points are awarded for the following criteria according to the following principles: Criterion price weight: 60% Criterion term of partial deliveries weight: 40% weighting

Opportunity closing date

27 June 2019

Value of contract

to be confirmed