Public procurement notice: Contract Notice
Published: 2020-06-05
Buyer: Comando Generale dell'Arma dei Carabinieri — Centro Unico Contrattuale
Country: IT
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33141000: Disposable medical supplies
Estimated value: 18000000 EUR
Submission deadline: 2020-06-25
Award criteria: Lowest price

Technical requirements: Медицински консумативи, с изключение на химическите и хематологични консумативи, за еднократна употреба
Niet-chemische medische gebruiksgoederen voor eenmalig gebruik en verbruiksartikelen voor hematologie
Accelerated open procedure for the conclusion of a maximum of 2 ‘framework agreements’ lasting 12 months, each with only one or a plurality of economic operators usefully classified in the ranking, for the supply of surgical masks in the context of the health emergency by Covid-19.
Price of clothing warehouse near the airport airport customs clearance of goods located on the national territory at the regional capital level, unless the A.D. do not communicate other place.
Supply of surgical masks or face masks for medical use, falling within the medical devices referred to in Legislative Decree no 24 February 1997, n. 46 and subsequent amendments.
Price of clothing warehouse near the airport airport customs clearance of goods located on the national territory at the regional capital level, unless the A.D. do not communicate other place.
Supply of surgical masks or face masks for medical use, falling within the medical devices referred to in Legislative Decree no. 24 February 1997, n. 46 and subsequent amendments.
All economic operators are allowed under art. 45 of Legislative Decree no 50/2016, including competitors specifically and temporarily grouped pursuant to art. 45, paragraph 2, lett. d) of Legislative Decree no 50/2016 and aggregations between companies participating in the network contract pursuant to art. 45, paragraph 2, lett. f) of Legislative Decree no. 50/2016, according to the procedures indicated in the tender specification.
All economic operators wishing to participate in this tender must produce, together with the remaining documentation provided in this notice and in the tender specifications, under penalty of exclusion from this procedure, the declaration signed by the legal representative, or by his agent, certifying its global turnover for the 3-year period 2017-2019, whose annual average must be at least half the value of the lot for which the offer is presented (regardless of the quantity of templates offered by the economic operator). If the tenderer submits an offer for both lots in the tender, the average of the global turnover for the last three years must be at least half the total amount placed at the tender base.
All economic operators wishing to participate in this tender must produce, together with the remaining documentation provided for in this call for tender and in the tender specification, under penalty of exclusion from this procedure, the quality certification relating to the ISO 9001 quality management system, in validity course, issued by ACCREDIA accredited body or other body in mutual recognition. In the case of R.T.I. (constituting or constituting) said certification must be in the possession of all the economic operators gathered.
Furthermore, with reference to the manufacturer of the surgical masks that the competitor intends to offer, the following documentation must be produced — under penalty of exclusion from the tender:
(a) certification relating to the UNI CEI EN ISO 13485: 2016 quality management system, currently valid, regarding requirements that allow an organization to demonstrate its ability to provide medical devices and related services that comply with the regulatory requirements applicable to such medical devices;
(b) certification of conformity to UNI EN 14683: 2019, currently valid, relating to the product to be offered, which certifies the possession of the following performance requirements provided by the aforementioned standard for Type IIR (ref. UNI EN 14683: 2019 para 5.2 .7):
The aforementioned certification of compliance with UNI EN 14683: 2019 must be accompanied by the official test report issued by a notified body, verifiable by accessing the ‘NANDO’ system of the European Commission, which registers all the bodies notified for EU Regulation 425/2016. at the link: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.notifiedbody&cou_id=380 or through the website of the Italian Accreditation Accredia Body (www.accredia.it), pursuant to Directive 89/686 / EEC and Regulation (EU) 2016/425 on Personal Protective Equipment (PPE). In addition, the aforementioned test report must include the results of the following biocompatibility tests pursuant to EN ISO 10993-1: 2019 (ref. UNI EN 14683: 2019 para. 5.2.6):
The official test report must also include the photographic reproduction of the objects being analyzed.

Eligibility requirements: All economic operators are allowed under art. 45 of Legislative Decree no 50/2016, including competitors specifically and temporarily grouped pursuant to art. 45, paragraph 2, lett. d) of Legislative Decree no 50/2016 and aggregations between companies participating in the network contract pursuant to art. 45, paragraph 2, lett. f) of Legislative Decree no. 50/2016, according to the procedures indicated in the tender specification.
Sono ammessi tutti gli operatori economici previsti dall’art. 45 del D.Lgs. n. 50/2016, compresi i concorrenti appositamente e temporaneamente raggruppati ai sensi dell’art. 45, comma 2, lett. d) del D.Lgs. n. 50/2016 e aggregazioni tra imprese aderenti al contratto di rete ai sensi dell’art. 45, comma 2, lett. f) del D.Lgs. n. 50/2016, secondo le modalità indicate nel disciplinare di gara.

Award value: 18000000