TEER system for general use

DEK-1637 Procurement of a transcatheter heart valve clip (TEER) system for the DE KK Cardiology and Cardiac Surgery Clinic in two parts. A framework purchase agreement for the procurement of 25 TEER systems for general use and 25 TEER systems for special cases for the DE KK Cardiology and Cardiac Surgery Clinic. Part 1 TEER system for general use A device suitable for percutaneous treatment of regurgitation, available in at least four different sizes of clips. • Clip selection available in 4 different dimensions; (Arm length and width: 9x4 mm, 9x6 mm, 12x4 mm, 12x6 mm) • Independent movement of the grasping arms • Delivery system consisting of 2 catheters/components • Possibility of measuring atrial pressure through the device • Clinical study involving at least 600 patients at a minimum of 60 sites with the device and its previous generations, with a follow-up of at least two years • More than 100,000 implants worldwide with the device and its previous generations The specified quantity applies to 12 months. The contract can be extended by 12 months. Option: +200% quantity deviation (pursuant to Section 6 (2a) of Government Decree 16/2012. (II.16.)) The contracting authority applies the sole evaluation criterion of the lowest price in accordance with Section 6 (3) of Government Decree 16/2012. (II. 16.) on the specific rules for public procurement of medicines and medical devices. Only factory new, unused devices can be offered. Further requirements are detailed in the technical description, which is part of the procurement documents. The tenderer must indicate the specific name, type designation, manufacturer, country of origin, and product code of the goods in their offer. The procurement includes delivery to the place of performance. Warranty period: 12 months from the date of handover for the goods. Pursuant to Section 9 (2) of Government Decree 16/2012. (II.16.), the successful tenderer must prove the conformity of the offered products at the time of contract conclusion with the manufacturer's declaration of conformity required by the MDR or the regulation on medical devices, and – if required for the placing on the market of the medical device under the MDR or the regulation on medical devices – with the CE conformity assessment certificate. As a result of the public procurement procedure, the contracting authority will conclude a framework purchase agreement, which will be valid for a fixed period of 12 months from its conclusion or until the framework quantity specified in this point of the invitation to tender and in Annex 1 to the framework agreement (quantity calculated including the option, if the option is exercised) is exhausted, whichever occurs first. Pursuant to Section 46 (3) of Government Decree 321/2015. (X. 30.), if the documentation (public procurement technical description) refers to a specific standard, technical approval, technical specifications, technical recommendation, or a product of a specific make, origin or type, procedure, activity, person, patent or trademark, the designation is made solely to clearly define the nature of the subject matter, and the phrase "or equivalent" must be understood alongside the designation, based on which the contracting authority is obliged to accept an equivalent or better solution than those specified in the documentation. The tenderer – if they intend to offer an equivalent device, solution, etc. instead of the technical content referred to – must submit the document(s) supporting the equivalence in their offer. The contracting authority draws the tenderers' attention to the fact that the document supporting the equivalence may include, but is not limited to, technical documentation from the manufacturer or a certificate from an independent, professionally recognized body.